A Trial Evaluating the Safety and Immunogenicity of 3 COV... | NCT05037097 | Trialant
NCT05037097
Sponsor
Arcturus Therapeutics, Inc.
Status
Completed
Last Update Posted
Oct 15, 2025Actual
Enrollment
72Actual
Phase
Phase 1Phase 2
Conditions
COVID-19
SARS-CoV-2 Infection
Corona Virus Infection
Interventions
ARCT-165
ARCT-154
ARCT-021
Countries
United States
Singapore
South Africa
Protocol Section
Identification Module
NCT ID
NCT05037097
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ARCT-165-01
Secondary IDs
Not provided
Brief Title
A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults
Official Title
A Phase 1/2 Randomized, Observer-Blind Study of the Safety, Reactogenicity, and Immunogenicity of 3 SARS-CoV-2 RNA Vaccine Candidates in Adults Previously Vaccinated and Not Previously Vaccinated Against SARS-CoV-2
Acronym
Not provided
Organization
Arcturus Therapeutics, Inc.INDUSTRY
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 30, 2021Actual
Primary Completion Date
Dec 19, 2023Actual
Completion Date
Dec 19, 2023Actual
First Submitted Date
Aug 30, 2021
First Submission Date that Met QC Criteria
Sep 3, 2021
First Posted Date
Sep 8, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Aug 28, 2025
Results First Submitted that Met QC Criteria
Sep 30, 2025
Results First Posted Date
Oct 15, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 16, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Oct 15, 2025Actual
Last Update Submitted Date
Sep 30, 2025
Last Update Posted Date
Oct 15, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Arcturus Therapeutics, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 1/2, randomized, observer-blind study in healthy adults. The study will evaluate the safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 self-amplifying RNA vaccine candidates against COVID-19 in adults previously vaccinated and not previously vaccinated against SARS-CoV-2.
Detailed Description
The study will initially enroll approximately 72 adult participants into 2 cohorts (A and B). Cohort A is further sub-divided into two sub-cohorts which include 12 participants who are seronegative, not previously vaccinated at screening (Sub-cohort A1) and 24 participants who are seropositive, not previously vaccinated at screening (Sub-cohort A2).
Within the first cohort (Cohort A), Sub-cohort A1 will include a total of 12 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Sub-cohort A2 will include a total of 24 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Study vaccines will be given as 2 doses separated by 28 days.
The second cohort (Cohort B) will include a total of 36 adult participants ≥21 to ≤65 years of age who have been previously vaccinated (5 months or longer prior to study enrollment) with SARS-CoV-2 vaccine. Study vaccines will be given as single doses.
Additional cohorts may increase the age range of participants up to 80 years of age.
Conditions Module
Conditions
COVID-19
SARS-CoV-2 Infection
Corona Virus Infection
Keywords
SARS-CoV-2 Vaccine
Coronavirus Virus Diseases
RNA COVID-19
COVID-19 Vaccine Arcturus
Self Amplifying RNA Vaccine
Variants of Concern
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
72Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Study Group 1, Adult Participants Seronegative, Not Previously Vaccinated randomized to ARCT-165
Experimental
Participants will receive one dose of ARCT-165 on Day 1 and one dose of ARCT-165 on Day 29
Biological: ARCT-165
Study Group 2, Adult Participants Seronegative, Not Previously Vaccinated randomized to ARCT-154
Experimental
Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29
Biological: ARCT-154
Study Group 3, Adult Participants Seronegative, Not Previously Vaccinated to receive ARCT-021
Experimental
Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29
Biological: ARCT-021
Study Group 4, Adult Participants Seropositive, Not Previously Vaccinated to receive ARCT-021
Experimental
Participants will receive one dose of ARCT-021 on Day 1 and one dose of ARCT-021 on Day 29
Biological: ARCT-021
Study Group 5, Adult Participants Seropositive, Not Previously Vaccinated randomized to ARCT-154
Experimental
Participants will receive one dose of ARCT-154 on Day 1 and one dose of ARCT-154 on Day 29
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ARCT-165
Biological
Dose 3
Study Group 1, Adult Participants Seronegative, Not Previously Vaccinated randomized to ARCT-165
Study Group 6, Adult Participants Previously Vaccinated randomized to receive ARCT-165
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs)
Solicited local AEs were defined as injection site erythema, injection site pain, injection site induration, and injection site tenderness. Solicited systemic AEs were defined as arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, nausea and vomiting. Data are reported for the number of participants with solicited local and solicited systemic AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to Day 8 (7 days after first vaccine administration for Cohorts A1, A2 and B), and up to Day 36 (7 days after second vaccine administration for Cohorts A1 and A2)
Number of Participants Reporting Unsolicited AEs
Unsolicited AEs were defined as any spontaneously reported or discovered AE. Data are reported for the number of participants with unsolicited AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Up to Day 29 (28 days after vaccine administration for Cohort B), and up to Day 57 (up to 28 days after each vaccine administration for Cohorts A1 and A2)
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs)
An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) with a health care provider (HCP) (e.g., nurse, nurse practitioner, physician's assistant, physician), including visits to a study site for unscheduled assessments (e.g., rash assessment, abnormal laboratory follow up, coronavirus disease 2019 [COVID-19]) and visits to HCPs external to the study site (e.g., urgent care, primary care physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Individuals who:
Are able to provide consent
Agree to comply with all study visits and procedures
Are willing and able to adhere to study restrictions
Are sexually active and willing to adhere to contraceptive requirements
Are male, female, or transgender ≥21 to ≤80 years of age
For the previously vaccinated groups only, received 2 doses of SARS-CoV-2 vaccine 5 months or longer prior to study enrollment
Exclusion Criteria:
Individuals who:
For the unvaccinated groups only, previously received any investigational or authorized MERS-CoV, SARS-CoV, and SARS-CoV-2 vaccines (including ARCT-021)
For the previously vaccinated groups only, previously received BNT162b2 but have not received 2 doses within at least 5 months prior to study enrollment
Are planning to receive other COVID-19 vaccines during the study period
Recently received other vaccines
Have a fever or are feeling sick close to the time of the first study vaccination
Have a known history of COVID-19 disease or asymptomatic SARS-CoV-2 infection
Are pregnant or breastfeeding
Have had a severe reaction to previous vaccines
Have a severe or uncontrolled disease(s) that may interfere with the interpretation of the study
Have some respiratory diseases
Have some significant heart diseases
Have some neurological conditions
Have sickle cell disease or some other blood disorders
Have had a major surgery within the past 6 months
Have a history of chronic liver disease
Have a history of autoimmune disease or immunodeficiency
Have received allergy injections, interferon, immunomodulators, cytotoxic drugs or other similar toxic drugs.
Have received blood products
Have a positive test for hepatitis B or C or human immunodeficiency virus
Have uncontrolled hypertension
Have had cancer except for cancers that were treated and that have low risk of returning
Are obese
Are Investigator site staff members, employees of Arcturus or the contract research organization (CRO) directly involved in the conduct of the study, or site staff members otherwise supervised by the Investigator or immediate family members of any of the previously mentioned individuals
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
21 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Program Director
Arcturus Therapeutics
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Arcturus Investigational Site 202
Wichita
Kansas
67207
United States
Arcturus Investigational Site 201
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Individual participant data will only be made available to study investigators at this time.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 22, 2022
Aug 28, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The study will evaluate 3 investigational vaccines in parallel.
Study Group 6, Adult Participants Previously Vaccinated randomized to receive ARCT-165
Experimental
Participants will receive one dose of ARCT-165 on Day 1
Biological: ARCT-165
Study Group 7, Adult Participants Previously Vaccinated randomized to receive ARCT-154
Experimental
Participants will receive one dose of ARCT-154 on Day 1
Biological: ARCT-154
Study Group 8, Adult Participants Previously Vaccinated randomized to receive ARCT-021
Experimental
Participants will receive one dose of ARCT-021 on Day 1
Biological: ARCT-021
ARCT-154
Biological
Dose 2
Study Group 2, Adult Participants Seronegative, Not Previously Vaccinated randomized to ARCT-154
Study Group 5, Adult Participants Seropositive, Not Previously Vaccinated randomized to ARCT-154
Study Group 7, Adult Participants Previously Vaccinated randomized to receive ARCT-154
ARCT-021
Biological
Dose 1
Study Group 3, Adult Participants Seronegative, Not Previously Vaccinated to receive ARCT-021
Study Group 4, Adult Participants Seropositive, Not Previously Vaccinated to receive ARCT-021
Study Group 8, Adult Participants Previously Vaccinated randomized to receive ARCT-021
Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC)
Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral D614G variant. Data are reported in international units per milliliter (IU/mL).
Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC
Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral B.1.351 (beta) variant. Data are reported in arbitrary units per milliliter (AU/mL).
Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR)
Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral D614G variant.
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR
Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral B.1.351 (beta) variant.
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G variant.
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral B.1.351 (beta) variant.
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154. Data are reported for the ARCT-165 and ARCT-021 arms (vs ARCT-154 values).
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-021 vs ARCT-165. Data are reported for the ARCT-021 arm (vs ARCT-165 values).
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohort A1, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs
Spike binding antibody levels expressed as GMCs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibodies for ancestral strain.
Baseline and Day 57 for Cohorts A1 and A2, Baseline and Day 15 for Cohort B
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs
Spike binding antibody levels expressed as GMFRs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibody levels expressed as GMFR for ancestral strain.
Day 57 for Cohorts A1 and A2, Day 15 for Cohort B
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels
Data are reported for ancestral, D614G, and B.1.351 variants for Spike binding antibodies and ancestral for RBD binding antibodies.
Day 57 for Cohorts A1 and A2, Day 15 for Cohort B
Kansas City
Missouri
64114
United States
Arcturus Investigational Site 101
Singapore
169608
Singapore
Arcturus Investigational Site 301
Diepkloof
Soweto
1862
South Africa
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
FG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
FG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
FG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
FG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
FG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
FG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0036 subjects
FG00418 subjects
FG00512 subjects
FG00612 subjects
FG00712 subjects
Received at Least 1 Dose of Study Drug
FG0004 subjects
FG0014 subjects
FG0024 subjects
FG0036 subjects
FG00418 subjects
FG00512 subjects
FG00612 subjects
FG00712 subjects
COMPLETED
FG0004 subjects
FG0012 subjects
FG0024 subjects
FG0035 subjects
FG00417 subjects
FG0059 subjects
FG00612 subjects
FG00712 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Measured in the Safety Set (SS): The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
BG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
BG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
BG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
BG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
BG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
BG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
BG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0014
BG0024
BG0036
BG00418
BG00512
BG00612
BG00712
BG00872
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00046± 17
BG00134± 10
BG00250± 17
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Reporting Solicited Local or Systemic Adverse Events (AEs)
Solicited local AEs were defined as injection site erythema, injection site pain, injection site induration, and injection site tenderness. Solicited systemic AEs were defined as arthralgia, chills, diarrhea, dizziness, fatigue, fever (categorized by measured body temperature), headache, myalgia, nausea and vomiting. Data are reported for the number of participants with solicited local and solicited systemic AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received. Number analyzed for Cohort B arms for AEs after Dose 2 = 0 as participants in this Cohort received only a single dose of treatment.
Posted
Count of Participants
Participants
Up to Day 8 (7 days after first vaccine administration for Cohorts A1, A2 and B), and up to Day 36 (7 days after second vaccine administration for Cohorts A1 and A2)
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Units
Counts
Participants
OG0004
OG0014
OG0024
OG003
Title
Denominators
Categories
Any Solicited Local AE After Dose 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG003
Primary
Number of Participants Reporting Unsolicited AEs
Unsolicited AEs were defined as any spontaneously reported or discovered AE. Data are reported for the number of participants with unsolicited AEs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Posted
Count of Participants
Participants
Up to Day 29 (28 days after vaccine administration for Cohort B), and up to Day 57 (up to 28 days after each vaccine administration for Cohorts A1 and A2)
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Primary
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), AEs Leading to Discontinuation From Study Vaccine/Study Withdrawal, or Serious Adverse Events (SAEs)
An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) with a health care provider (HCP) (e.g., nurse, nurse practitioner, physician's assistant, physician), including visits to a study site for unscheduled assessments (e.g., rash assessment, abnormal laboratory follow up, coronavirus disease 2019 [COVID-19]) and visits to HCPs external to the study site (e.g., urgent care, primary care physician). An SAE was defined as any event that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
Posted
Count of Participants
Participants
Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
Primary
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Concentration (GMC)
Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral D614G variant. Data are reported in international units per milliliter (IU/mL).
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Primary
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMC
Blood samples were collected to assess participants' immune response. GMC data are reported for the pseudoviral B.1.351 (beta) variant. Data are reported in arbitrary units per milliliter (AU/mL).
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Baseline, Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2; Baseline, Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Primary
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as Geometric Mean Fold Rise (GMFR)
Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral D614G variant.
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
95% Confidence Interval
ratio
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Primary
SARS-CoV-2 Serum Neutralizing Antibody Levels, Expressed as GMFR
Blood samples were collected to assess participants' immune response. GMFR data are reported for the pseudoviral B.1.351 (beta) variant.
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
95% Confidence Interval
ratio
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Primary
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral D614G Variant)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G variant.
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Primary
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Serum Neutralizing Antibody Levels (Pseudoviral B.1.351 [Beta] Variant)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral B.1.351 (beta) variant.
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Primary
GMC Ratio (ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-165 vs ARCT-154 and ARCT-021 vs ARCT-154. Data are reported for the ARCT-165 and ARCT-021 arms (vs ARCT-154 values).
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
95% Confidence Interval
ratio
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohorts A1 and A2, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Primary
GMC Ratio (ARCT-021 vs ARCT-165 Cohorts A1 and B)
Blood samples were collected to assess participants' immune response. Data are reported for the pseudoviral D614G Variant, B.1.351 Variant, B.1.617.2 Variant, BA.1 Variant for the GMC ratio of ARCT-021 vs ARCT-165. Data are reported for the ARCT-021 arm (vs ARCT-165 values).
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
95% Confidence Interval
ratio
Days 29, 57, 209, Final Visit (approx. Day 394) for Cohort A1, and Days 15, 29, 91, 181, 271 and Final Visit (approx. Day 366) for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
Primary
SARS-CoV-2 Full-length Spike and Receptor-binding Domain (RBD) Binding Antibody Levels, Expressed as GMCs
Spike binding antibody levels expressed as GMCs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibodies for ancestral strain.
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
95% Confidence Interval
AU/mL
Baseline and Day 57 for Cohorts A1 and A2, Baseline and Day 15 for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Primary
Changes in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels, Expressed as GMFRs
Spike binding antibody levels expressed as GMFRs are reported for ancestral, D614G, and B.1.351 variants and RBD binding antibody levels expressed as GMFR for ancestral strain.
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed=participants evaluable for endpoint. Number analyzed=participants evaluable at specified timepoint.
Posted
Geometric Mean
95% Confidence Interval
ratio
Day 57 for Cohorts A1 and A2, Day 15 for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Primary
Number of Participants Achieving Greater Than or Equal to 4-fold Rise From Before Vaccination in SARS-CoV-2 Full-length Spike and RBD Binding Antibody Levels
Data are reported for ancestral, D614G, and B.1.351 variants for Spike binding antibodies and ancestral for RBD binding antibodies.
Immunogenicity Analysis Set, all eligible enrolled participants who received the specified number of doses of study vaccine to which they were assigned within the predefined window, had ≥1 valid/evaluable immunogenicity results after specified dose, had blood collection within an appropriate window after specified dose, and no other major protocol deviations. Overall number participants analyzed =participants evaluable for endpoint. Number analyzed =participants evaluable at specified timepoint.
Posted
Count of Participants
Participants
Day 57 for Cohorts A1 and A2, Day 15 for Cohort B
ID
Title
Description
OG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Time Frame
Through Final Visit (365 days after last study vaccine dose); up to a maximum of approximately 394 days
Description
Measured in the SS: The SS included all randomized participants who received at least one dose of the study vaccine. Assignment of participants to study vaccine group was based on the study vaccine actually received.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort A1: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
0
4
0
4
3
4
EG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
0
4
0
4
3
4
EG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
0
4
0
4
2
4
EG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
0
6
1
6
4
6
EG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
0
18
0
18
15
18
EG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
0
12
1
12
9
12
EG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
0
12
0
12
9
12
EG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
0
12
0
12
10
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Spontaneous abortion
Pregnancy, puerperium and perinatal conditions
MedDRA v24.0
Systematic Assessment
N values for at risk have been adjusted as this is a sex-specific event.
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
6
OG00418
OG00512
OG00612
OG00712
6
ParticipantsOG00418
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00712
Title
Measurements
OG0003
OG0014
OG0023
OG0035
OG00410
OG00512
OG00610
OG00710
Any Solicited Local AE After Dose 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG00418
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0002
OG0012
OG0024
OG003
Any Solicited Systemic AE After Dose 1
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG00418
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00712
Title
Measurements
OG0003
OG0013
OG0021
OG003
Any Solicited Systemic AE After Dose 2
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG00418
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0002
OG0012
OG0023
OG003
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0036
OG00418
OG00512
OG00612
OG00712
Title
Denominators
Categories
Title
Measurements
OG0003
OG0013
OG0022
OG0034
OG00415
OG0059
OG0069
OG00710
OG001
Cohort A1: ARCT-165
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-165 on Days 1 and 29. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0014
OG0024
OG0036
OG00418
OG00512
OG00612
OG00712
Title
Denominators
Categories
Any MAAEs
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0043
OG0052
OG0061
OG0070
Any AEs Leading to Discontinuation from Study Vaccine/Study Withdrawal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Any SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0036
OG00418
OG00512
OG00612
OG00712
Title
Denominators
Categories
Pseudoviral D614G; Baseline
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG00418
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00712
Title
Measurements
OG0008(NA to NA)Confidence interval data were non-estimable because baseline values were below the limit of quantification for all participants in the arm.
OG0018(6 to 11)
OG00212(4 to 33)
OG003
Pseudoviral D614G; Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral D614G; Day 29
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Pseudoviral D614G; Day 57
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Pseudoviral D614G; Day 91
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral D614G; Day 181
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral D614G; Day 209
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0034
Pseudoviral D614G; Day 271
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral D614G; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG003
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0036
OG00418
OG00512
OG00612
OG00712
Title
Denominators
Categories
Pseudoviral B.1.351 (Beta); Baseline
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG00418
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00712
Title
Measurements
OG00014(NA to NA)Confidence interval data were non-estimable because baseline values were below the limit of quantification for all participants in the arm.
OG00114(NA to NA)Confidence interval data were non-estimable because baseline values were below the limit of quantification for all participants in the arm.
OG00214(13 to 15)
OG003
Pseudoviral B.1.351 (Beta); Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral B.1.351 (Beta); Day 29
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Pseudoviral B.1.351 (Beta); Day 57
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0036
Pseudoviral B.1.351 (Beta); Day 91
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral B.1.351 (Beta); Day 181
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral B.1.351 (Beta); Day 209
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0034
Pseudoviral B.1.351 (Beta); Day 271
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Pseudoviral B.1.351 (Beta); Final Visit Cohort A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG003
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG0036
OG00417
OG00512
OG00612
OG00712
Title
Denominators
Categories
Pseudoviral D614G; Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00711
Title
Measurements
OG00516(9 to 30)
OG00622(9 to 50)
OG00728(11 to 67)
Pseudoviral D614G; Day 29
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Pseudoviral D614G; Day 57
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Pseudoviral D614G; Day 91
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral D614G; Day 181
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral D614G; Day 209
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0034
Pseudoviral D614G; Day 271
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral D614G; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG003
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG0036
OG00417
OG00512
OG00612
OG00712
Title
Denominators
Categories
Pseudoviral B.1.351 (Beta); Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00711
Title
Measurements
OG00514(8 to 26)
OG00634(16 to 72)
OG00725(12 to 51)
Pseudoviral B.1.351 (Beta); Day 29
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Pseudoviral B.1.351 (Beta); Day 57
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG0036
Pseudoviral B.1.351 (Beta); Day 91
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral B.1.351 (Beta); Day 181
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral B.1.351 (Beta); Day 209
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG0034
Pseudoviral B.1.351 (Beta); Day 271
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG003
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG0036
OG00417
OG00512
OG00612
OG00712
Title
Denominators
Categories
Pseudoviral D614G; Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00711
Title
Measurements
OG00511
OG00611
OG00710
Pseudoviral D614G; Day 29
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Pseudoviral D614G; Day 57
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Pseudoviral D614G; Day 91
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral D614G; Day 181
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral D614G; Day 209
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0034
Pseudoviral D614G; Day 271
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral D614G; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG003
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG0036
OG00417
OG00512
OG00612
OG00712
Title
Denominators
Categories
Pseudoviral B.1.351 (Beta); Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00711
Title
Measurements
OG00511
OG00611
OG00710
Pseudoviral B.1.351 (Beta); Day 29
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Pseudoviral B.1.351 (Beta); Day 57
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Pseudoviral B.1.351 (Beta); Day 91
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral B.1.351 (Beta); Day 181
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral B.1.351 (Beta); Day 209
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG0034
Pseudoviral B.1.351 (Beta); Day 271
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pseudoviral B.1.351 (Beta); Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Pseudoviral B.1.351 (Beta); Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0022
ParticipantsOG003
OG002
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG003
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
Units
Counts
Participants
OG0004
OG0012
OG0026
OG00312
OG00412
Title
Denominators
Categories
Pseudoviral D614G; Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00312
ParticipantsOG00412
Title
Measurements
OG0030.41(0.179 to 0.924)
OG0040.58(0.240 to 1.405)
Pseudoviral D614G; Day 29
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG00312
Pseudoviral D614G; Day 57
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0030
Pseudoviral D614G; Day 91
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
Pseudoviral D614G; Day 181
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0036
Pseudoviral D614G; Day 209
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
Pseudoviral D614G; Day 271
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG003
Pseudoviral D614G; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Pseudoviral B.1.351; Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00312
Pseudoviral B.1.351; Day 29
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG00312
Pseudoviral B.1.351; Day 57
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0030
Pseudoviral B.1.351; Day 91
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
Pseudoviral B.1.351; Day 181
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0036
Pseudoviral B.1.351; Day 209
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
Pseudoviral B.1.351; Day 271
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Pseudoviral B.1.351; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG003
Pseudoviral B.1.351; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Pseudoviral B.1.617.2; Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00312
Pseudoviral B.1.617.2; Day 29
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG00312
Pseudoviral B.1.617.2; Day 57
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0030
Pseudoviral B.1.617.2; Day 91
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
Pseudoviral B.1.617.2; Day 181
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0036
Pseudoviral B.1.617.2; Day 209
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
Pseudoviral B.1.617.2; Day 271
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Pseudoviral B.1.617.2; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG003
Pseudoviral B.1.617.2; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Pseudoviral BA.1 Variant; Day 15
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00312
Pseudoviral BA.1 Variant; Day 29
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG00312
Pseudoviral BA.1 Variant; Day 57
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0030
Pseudoviral BA.1 Variant; Day 91
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00310
Pseudoviral BA.1 Variant; Day 181
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0036
Pseudoviral BA.1 Variant; Day 209
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0024
ParticipantsOG0030
Pseudoviral BA.1 Variant; Day 271
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Pseudoviral BA.1 Variant; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0023
ParticipantsOG003
Pseudoviral BA.1 Variant; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Units
Counts
Participants
OG0004
OG00112
Title
Denominators
Categories
Pseudoviral D614G; Day 15
ParticipantsOG0000
ParticipantsOG00112
Title
Measurements
OG0010.70(0.368 to 1.335)
Pseudoviral D614G; Day 29
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0004.00(0.063 to 252.690)
OG001
Pseudoviral D614G; Day 57
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0000.48(0.004 to 53.354)
Pseudoviral D614G; Day 91
ParticipantsOG0000
ParticipantsOG00110
Title
Measurements
OG0011.06(0.460 to 2.432)
Pseudoviral D614G; Day 181
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG0010.70(0.186 to 2.624)
Pseudoviral D614G; Day 209
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG000NA(NA to NA)Data were non-estimable because values were below the limit of quantification for all participants in the arm.
Pseudoviral D614G; Day 271
ParticipantsOG0000
ParticipantsOG0015
Title
Measurements
OG0010.28(0.117 to 0.684)
Pseudoviral D614G; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG000NA(NA to NA)Data were non-estimable because values were below the limit of quantification for all participants in the arm.
Pseudoviral D614G; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0015
Title
Measurements
OG0010.29(0.062 to 1.377)
Pseudoviral B.1.351; Day 15
ParticipantsOG0000
ParticipantsOG00112
Title
Measurements
OG0010.37(0.192 to 0.731)
Pseudoviral B.1.351; Day 29
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0000.54(0.061 to 4.779)
OG001
Pseudoviral B.1.351; Day 57
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0000.05(0.004 to 0.609)
Pseudoviral B.1.351; Day 91
ParticipantsOG0000
ParticipantsOG00110
Title
Measurements
OG0010.52(0.232 to 1.160)
Pseudoviral B.1.351; Day 181
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG0010.56(0.122 to 2.616)
Pseudoviral B.1.351; Day 209
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG000NA(NA to NA)Data were non-estimable because values were below the limit of quantification for all participants in the arm.
Pseudoviral B.1.351; Day 271
ParticipantsOG0000
ParticipantsOG0015
Title
Measurements
OG0010.21(0.037 to 1.223)
Pseudoviral B.1.351; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG000NA(NA to NA)Data were non-estimable because values were below the limit of quantification for all participants in the arm.
Pseudoviral B.1.351; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG0010.14(0.028 to 0.688)
Pseudoviral B.1.617.2; Day 15
ParticipantsOG0000
ParticipantsOG00112
Title
Measurements
OG0010.63(0.328 to 1.210)
Pseudoviral B.1.617.2; Day 29
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0003.16(0.028 to 357.696)
OG001
Pseudoviral B.1.617.2; Day 57
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0001.26(0.053 to 29.735)
Pseudoviral B.1.617.2; Day 91
ParticipantsOG0000
ParticipantsOG00110
Title
Measurements
OG0010.68(0.266 to 1.740)
Pseudoviral B.1.617.2; Day 181
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG0010.56(0.159 to 1.948)
Pseudoviral B.1.617.2; Day 209
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG000NA(NA to NA)Data were non-estimable because values were below the limit of quantification for all participants in the arm.
Pseudoviral B.1.617.2; Day 271
ParticipantsOG0000
ParticipantsOG0015
Title
Measurements
OG0010.31(0.109 to 0.904)
Pseudoviral B.1.617.2; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG000NA(NA to NA)Data were non-estimable because values were below the limit of quantification for all participants in the arm.
Pseudoviral B.1.617.2; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG0010.27(0.065 to 1.097)
Pseudoviral BA.1 Variant; Day 15
ParticipantsOG0000
ParticipantsOG00112
Title
Measurements
OG0010.29(0.156 to 0.537)
Pseudoviral BA.1 Variant; Day 29
ParticipantsOG0003
ParticipantsOG00112
Title
Measurements
OG0001.45(0.304 to 6.868)
OG001
Pseudoviral BA.1 Variant; Day 57
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG0000.12(0.003 to 4.660)
Pseudoviral BA.1 Variant; Day 91
ParticipantsOG0000
ParticipantsOG00110
Title
Measurements
OG0010.43(0.182 to 0.996)
Pseudoviral BA.1 Variant; Day 181
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG0010.27(0.059 to 1.217)
Pseudoviral BA.1 Variant; Day 209
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG000NA(NA to NA)Data were non-estimable because values were below the limit of quantification for all participants in the arm.
Pseudoviral BA.1 Variant; Day 271
ParticipantsOG0000
ParticipantsOG0015
Title
Measurements
OG0010.15(0.042 to 0.570)
Pseudoviral BA.1 Variant; Final Visit Cohorts A1 and A2 (approx. Day 394)
ParticipantsOG0004
ParticipantsOG0010
Title
Measurements
OG000NA(NA to NA)Data were non-estimable because values were below the limit of quantification for all participants in the arm.
Pseudoviral BA.1 Variant; Final Visit Cohort B (approx. Day 366)
ParticipantsOG0000
ParticipantsOG0016
Title
Measurements
OG0010.12(0.024 to 0.622)
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0036
OG00418
OG00512
OG00612
OG00712
Title
Denominators
Categories
Baseline; RBD (Ancestral)
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG00418
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00712
Title
Measurements
OG0000.0(0.0 to 0.0)
OG0010.1(0.0 to 1.2)
OG0020.1(0.0 to 0.7)
OG003
Baseline; Spike (Ancestral)
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
Baseline; Spike (D614G)
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
Baseline; Spike (B.1.351)
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0036
Day 57; RBD (Ancestral)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Day 57; Spike (Ancestral)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Day 57; Spike (D614G)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Day 57; Spike (B.1.351)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Day 15; RBD (Ancestral)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 15; Spike (Ancestral)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 15; Spike (D614G)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 15; Spike (B.1.351)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG0036
OG00415
OG00512
OG00612
OG00711
Title
Denominators
Categories
Day 57; RBD (Ancestral)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG00415
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG000129(6 to 2894)
OG001286(0 to 46860600000)
OG002110(8 to 1560)
OG003
Day 57; Spike (Ancestral)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Day 57; Spike (D614G)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Day 57; Spike (B.1.351)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Day 15; RBD (Ancestral)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 15; Spike (Ancestral)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 15; Spike (D614G)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 15; Spike (B.1.351)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Cohort A1: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seronegative at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG003
Cohort A2: ARCT-021
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-021 on Days 1 and 29. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG004
Cohort A2: ARCT-154
Participants ≥21 to ≤65 years of age who had not been previously vaccinated with a SARS-CoV-2 vaccine and were seropositive at screening were randomized to receive two doses of ARCT-154 on Days 1 and 29. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
OG005
Cohort B: ARCT-021
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-021 on Day 1. ARCT-021 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain.
OG006
Cohort B: ARCT-165
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-165 on Day 1. ARCT-165 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Beta variant.
OG007
Cohort B: ARCT-154
Participants ≥21 to ≤65 years of age who had been previously vaccinated (5 months or longer prior to study enrollment) with the BNT162b2 (Comirnaty) SARS-CoV-2 vaccine were randomized to receive a single dose of ARCT-154 on Day 1. ARCT-154 is a monovalent vaccine encoding for SARS-CoV-2 S glycoprotein of the Ancestral strain including the D614G mutation.
Units
Counts
Participants
OG0004
OG0012
OG0024
OG0036
OG00415
OG00512
OG00612
OG00711
Title
Denominators
Categories
Day 57; RBD (Ancestral)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
ParticipantsOG00415
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0004
OG0012
OG0024
OG003
Day 57; Spike (Ancestral)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Day 57; Spike (D614G)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Day 57; Spike (B.1.351)
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG0036
Day 15; RBD (Ancestral)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 15; Spike (Ancestral)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 15; Spike (D614G)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 15; Spike (B.1.351)
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
0 affected
10 at risk
EG0050 affected9 at risk
EG0060 affected6 at risk
EG0070 affected7 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0051 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
15 affected
18 at risk
EG0050 affected12 at risk
EG0061 affected12 at risk
EG0072 affected12 at risk
2 affected
6 at risk
EG0046 affected18 at risk
EG0054 affected12 at risk
EG0066 affected12 at risk
EG0076 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
1 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
1 affected
6 at risk
EG0041 affected18 at risk
EG0052 affected12 at risk
EG0060 affected12 at risk
EG0072 affected12 at risk
1 affected
6 at risk
EG0040 affected18 at risk
EG0052 affected12 at risk
EG0061 affected12 at risk
EG0072 affected12 at risk
0 affected
6 at risk
EG0042 affected18 at risk
EG0052 affected12 at risk
EG0061 affected12 at risk
EG0071 affected12 at risk
0 affected
6 at risk
EG0042 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
1 affected
6 at risk
EG0045 affected18 at risk
EG0051 affected12 at risk
EG0061 affected12 at risk
EG0071 affected12 at risk
1 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0051 affected12 at risk
EG0061 affected12 at risk
EG0071 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0042 affected18 at risk
EG0052 affected12 at risk
EG0061 affected12 at risk
EG0072 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0051 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
1 affected
6 at risk
EG0040 affected18 at risk
EG0051 affected12 at risk
EG0061 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0061 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0061 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0071 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0061 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0061 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0041 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0051 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0051 affected12 at risk
EG0060 affected12 at risk
EG0071 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0071 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0071 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0060 affected12 at risk
EG0071 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0061 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0061 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0061 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0051 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0051 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0061 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0050 affected12 at risk
EG0061 affected12 at risk
EG0070 affected12 at risk
0 affected
6 at risk
EG0040 affected18 at risk
EG0051 affected12 at risk
EG0060 affected12 at risk
EG0070 affected12 at risk
6
OG00410
5
OG0049
OG00512
OG0069
OG00711
5
OG00410
0
OG0040
OG0050
OG0060
OG0070
1
OG0040
OG0051
OG0060
OG0070
421
(74 to 2383)
OG004455(202 to 1028)
OG00587(51 to 148)
OG00694(29 to 301)
OG007114(58 to 224)
ParticipantsOG0040
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00711
Title
Measurements
OG0051415(927 to 2160)
OG0062019(1179 to 3459)
OG0073474(1577 to 7656)
ParticipantsOG00417
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00712
Title
Measurements
OG00036(0 to 2715)
OG0019(2 to 47)
OG00226(6 to 107)
OG0031966(592 to 6534)
OG0041949(1026 to 3701)
OG0051741(1001 to 3028)
OG0062202(1170 to 4145)
OG0074200(2274 to 7757)
ParticipantsOG00415
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00042(2 to 998)
OG00187(0 to 1334270362)
OG00270(11 to 452)
OG0032038(676 to 6143)
OG0043563(2083 to 6096)
ParticipantsOG0040
ParticipantsOG00510
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG0051796(1067 to 3024)
OG0061697(840 to 3429)
OG0073427(2113 to 5558)
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0079
Title
Measurements
OG0051072(450 to 2551)
OG0061534(552 to 4260)
OG0073041(1334 to 6932)
ParticipantsOG00416
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00090(2 to 3976)
OG00219(4 to 85)
OG0031340(100 to 17882)
OG0041402(819 to 2402)
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0079
Title
Measurements
OG005611(246 to 1518)
OG0062158(1198 to 3888)
OG0071965(789 to 4893)
0
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0077
Title
Measurements
OG005564(232 to 1370)
OG0061924(374 to 9900)
OG0072463(870 to 6976)
3
ParticipantsOG00411
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00060(2 to 2088)
OG00214(0 to 3129)
OG0031000(10 to 100036)
OG0041324(671 to 2609)
402
(92 to 1761)
OG004442(187 to 1042)
OG00538(21 to 70)
OG00644(15 to 130)
OG00760(31 to 117)
ParticipantsOG0040
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00711
Title
Measurements
OG005554(370 to 829)
OG0061479(824 to 2652)
OG0071692(905 to 3162)
ParticipantsOG00417
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00712
Title
Measurements
OG00017(7 to 45)
OG00132(0 to 1385422)
OG00217(12 to 24)
OG0031926(788 to 4710)
OG0041273(615 to 2634)
OG005664(447 to 986)
OG0061608(940 to 2749)
OG0071768(1061 to 2948)
ParticipantsOG00415
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00021(6 to 75)
OG001452(0 to 1024516559)
OG00227(10 to 71)
OG0032292(991 to 5300)
OG0043237(2123 to 4936)
ParticipantsOG0040
ParticipantsOG00510
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG005560(326 to 960)
OG0061079(559 to 2083)
OG0071376(838 to 2260)
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0079
Title
Measurements
OG005400(142 to 1126)
OG006708(219 to 2293)
OG0071202(512 to 2819)
ParticipantsOG00416
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00097(3 to 3668)
OG00214(13 to 16)
OG0031372(185 to 10163)
OG0041438(780 to 2652)
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0079
Title
Measurements
OG005175(30 to 1036)
OG006829(252 to 2724)
OG0071129(446 to 2858)
0
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0065
ParticipantsOG0078
Title
Measurements
OG005213(60 to 763)
OG0061532(389 to 6036)
OG0071578(604 to 4122)
3
ParticipantsOG00411
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00061(3 to 1082)
OG00214(NA to NA)Confidence interval data were non-estimable because values were below the limit of quantification for all participants in the arm.
OG0031502(45 to 50296)
OG004847(467 to 1535)
ParticipantsOG00417
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00712
Title
Measurements
OG0004.6(0.1 to 346.2)
OG0011.0(0.6 to 1.7)
OG0022.2(0.4 to 12.2)
OG0034.7(1.4 to 15.9)
OG0044.4(2.7 to 7)
OG00520(10 to 41)
OG00624(10 to 54)
OG00737(17 to 77)
ParticipantsOG00415
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0005.4(0.2 to 127.2)
OG00110.1(0 to 48765966.9)
OG0025.9(0.5 to 65)
OG0034.8(1.2 to 19.0)
OG0046.2(3.8 to 10)
ParticipantsOG0040
ParticipantsOG00510
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG00520(10 to 41)
OG00617(8 to 36)
OG00730(19 to 47)
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0079
Title
Measurements
OG00511(4 to 30)
OG00612(3 to 45)
OG00731(14 to 70)
ParticipantsOG00416
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG00011.4(0.3 to 506.9)
OG0021.4(0.1 to 14.7)
OG0033.2(0.7 to 14.2)
OG0042.7(1.8 to 4.1)
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0079
Title
Measurements
OG0055(1 to 19)
OG00613(2 to 71)
OG00720(10 to 43)
0
ParticipantsOG0040
ParticipantsOG0055
ParticipantsOG0065
ParticipantsOG0077
Title
Measurements
OG0056(1 to 27)
OG00627(5 to 147)
OG00725(7 to 88)
3
ParticipantsOG00411
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0007.7(0.2 to 266.2)
OG0020.8(0 to 329524.9)
OG0032.7(0.2 to 42.6)
OG0041.9(1.1 to 3.3)
ParticipantsOG00417
ParticipantsOG00512
ParticipantsOG00612
ParticipantsOG00712
Title
Measurements
OG0001.2(0.5 to 3.2)
OG0012.3(0 to 98958.7)
OG0021.2(0.8 to 1.7)
OG0034.8(1.6 to 14.0)
OG0043.2(1.3 to 7.5)
OG00517(10 to 31)
OG00637(17 to 77)
OG00729(16 to 54)
ParticipantsOG00415
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0001.5(0.4 to 5.4)
OG00132.3(0 to 73179754.2)
OG0021.9(0.7 to 4.9)
OG0035.7(1.4 to 22.7)
OG0045.6(3.3 to 9.7)
ParticipantsOG0040
ParticipantsOG00510
ParticipantsOG00611
ParticipantsOG00712
Title
Measurements
OG00514(7 to 27)
OG00623(10 to 51)
OG00723(15 to 35)
ParticipantsOG0040
ParticipantsOG0056
ParticipantsOG0069
ParticipantsOG0079
Title
Measurements
OG00510(4 to 26)
OG00612(1 to 98)
OG00724(10 to 56)
ParticipantsOG00416
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
Title
Measurements
OG0006.9(0.2 to 262.0)
OG0021.0(NA to NA)Confidence interval data were non-estimable because values were below the limit of quantification for all participants in the arm.