A Trial Evaluating the Safety and Effects of an RNA Vacci... | NCT04668339 | Trialant
NCT04668339
Sponsor
Arcturus Therapeutics, Inc.
Status
Terminated
Last Update Posted
May 15, 2025Actual
Enrollment
581Actual
Phase
Phase 2
Conditions
Covid19
SARS-CoV Infection
Corona Virus Infection
Interventions
ARCT-021 single dose priming
ARCT-021 two lower dose priming
ARCT-021 two higher dose priming
Placebo (two doses), priming
Randomized booster
Placebo booster
Countries
United States
Singapore
Protocol Section
Identification Module
NCT ID
NCT04668339
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ARCT-021-04
Secondary IDs
Not provided
Brief Title
A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults
Official Title
A Phase 2 Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of the SARS CoV-2 Vaccine ARCT-021 in Healthy Adult Participants
Acronym
Not provided
Organization
Arcturus Therapeutics, Inc.INDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
A decision was made to terminate the study for operational/business reasons. The study was not terminated for reasons of safety or immunogenicity.
Expanded Access Info
No
Start Date
Jan 7, 2021Actual
Primary Completion Date
Mar 1, 2022Actual
Completion Date
Mar 1, 2022Actual
First Submitted Date
Nov 25, 2020
First Submission Date that Met QC Criteria
Dec 10, 2020
First Posted Date
Dec 16, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Dec 23, 2024
Results First Submitted that Met QC Criteria
May 14, 2025
Results First Posted Date
May 15, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 14, 2025
Last Update Posted Date
May 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)
Yes
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 2, randomized, placebo-controlled, and observer-blind study in healthy adults.
The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19:
As 2 doses (at two different dose levels), separated by 28 days or as 1 dose
In adults 18 years of age and older
Detailed Description
This is a multiregional, multicenter, Phase 2, randomized, observer-blind study designed to evaluate the safety, reactogenicity, and immunogenicity of the study vaccine in younger and older adult participants. Enrolled participants will be randomly assigned to receive either study vaccine ARCT-021 or placebo (sterile saline).
Approximately 600 participants (300 each in younger [18 to <56 years of age in United States or 21 to <56 years of age in Singapore] and older [≥56 years of age] participants) will be enrolled (including at least 50% of participants in the older cohort ≥65 years of age). Participants will be stratified by age and then randomly assigned (3 ARCT-021:1 placebo) to receive 2 doses of study vaccine separated by 28 days. At 180 days after second study vaccination (Day 208), participants in Study Groups 1, 2, and 3 will be randomly assigned again to receive a single booster dose of study vaccine (randomly assigned as 1 ARCT-021:1 placebo). Study Group 4 will not be randomized but will receive 1 dose of placebo at Day 208. Study Groups are summarized in Table 1. Study vaccine will be administered in an observer-blind fashion. Participants will be followed for safety and immunogenicity through 180 days after booster vaccination (Day 388). At a subset of clinical sites, all enrolled participants will also undergo blood sampling for evaluation of CMI responses.
Vaccine doses will be assigned as follows:
Younger Age Cohort:
Study Group 1: n= 75 participants, ARCT-021 7.5 µg (first dose), Placebo (second dose Study Group 2: n= 75 participants, ARCT-021 5.0 µg (first dose), 5.0 µg (second dose) Study Group 3: n= 75 participants, ARCT-021 7.5 µg (first dose), 7.5 µg (second dose) Study Group 4: n= 75 participants, Placebo (first dose), Placebo (second dose)
Booster Vaccine:
Study Groups 1, 2, 3: 113 participants, ARCT-021 5.0 µg or 7.5 µg, 112 participants, Placebo Study Group 4: n= 75 participants, Placebo
Older Age Cohort:
Study Group 1: n= 75 participants, ARCT-021 7.5 µg (first dose), Placebo (second dose Study Group 2: n= 75 participants, ARCT-021 5.0 µg (first dose), 5.0 µg (second dose) Study Group 3: n= 75 participants, ARCT-021 7.5 µg (first dose), 7.5 µg (second dose) Study Group 4: n= 75 participants, Placebo (first dose), Placebo (second dose)
Booster Vaccine:
Study Groups 1, 2, 3: 113 participants, ARCT-021 5.0 µg or 7.5 µg, 112 participants, Placebo Study Group 4: n= 75 participants, Placebo
A DSMB will be in place to independently review the safety data of participants. Pausing Rules are also utilized in this study to reduce risk to study participants.
The expected duration of participation for an individual participant is approximately 14 months, inclusive of the Screening period.
Conditions Module
Conditions
Covid19
SARS-CoV Infection
Corona Virus Infection
Keywords
SARS-CoV-2 Vaccine
Coronavirus Virus Diseases
RNA COVID 19
COVID 19 Vaccine Arcturus
self amplifying RNA vaccine
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
581Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Study Group 1, Younger Adult Participants
Experimental
Participants will receive one dose of ARCT-021 on Day 0, one dose of Placebo (saline) on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 single dose priming
Biological: Randomized booster
Study Group 2, Younger Adult Participants
Experimental
Participants will receive one dose of ARCT-021 on Day 0, a second dose of ARCT-021 on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 two lower dose priming
Biological: Randomized booster
Study Group 3, Younger Adult Participants
Experimental
Participants will receive one dose of ARCT-021 on Day 0, a second dose of ARCT-021 on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 two higher dose priming
Biological: Randomized booster
Study Group 4, Younger Adult Participants
Placebo Comparator
Participants will receive one of Placebo (Saline) on Day 0, one dose of Placebo on Day 28, and one dose of Placebo on Day 208
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2)
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination
Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
For 7 days following each dose administration (Day 208 up to Day 215)
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Per prespecified analysis, solicited systemic adverse events were defined as fever, headache, fatigue, myalgia, arthralgia, nausea, chills, diarrhea, dizziness, and vomiting. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2)
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination
Days 0 and 56
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination
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 or female ≥18 or (in Singapore) ≥21 years of age
are medically stable
Exclusion Criteria:
Individuals who:
have had SARS-CoV-2 infection or COVID-19 disease.
have had cancer except for cancers that were treated and that have low risk of returning
have chronic kidney disease
have some chronic lung diseases
have some heart conditions
have compromised immune systems
are obese
have sickle cell disease or some other blood disorders
are current smokers and/or use illegal drugs
have Type 2 diabetics
are immunocompromised, immunodeficient or have had a transplant
have autoimmune disease
have other severe or uncontrolled diseases or disease that may interfere with the interpretation of the study
have a positive test for hepatitis B or C or human immunodeficiency virus
have had a severe reaction to previous investigational vaccines
have a fever or are feeling sick close to the time of the first vaccination of the study
have positive drug test at screening
are pregnant
are breastfeeding
have a bleeding disorder
have previously received an investigational coronavirus vaccine (SARS-CoV(1) or MERS) or who plan to be in other COVID-19 studies
have recently been vaccinated with other vaccines
have recently received blood products
who work at one of the clinic sites participating in this study, work at Arcturus, who work at other companies that monitor the study or close family members to the sites, Arcturus, or partners involved in study monitoring
other restrictions may apply
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Arcturus Investigational Site 103
Chandler
Arizona
85224
United States
Arcturus Investigational Site 107
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
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Participants will receive one dose of ARCT-021 on Day 0, one dose of Placebo (saline) on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 single dose priming
Biological: Randomized booster
Study Group 2, Older Adult Participants
Experimental
Participants will receive one dose of ARCT-021 on Day 0, a second dose of ARCT-021 on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 two lower dose priming
Biological: Randomized booster
Study Group 3, Older Adult Participants
Experimental
Participants will receive one dose of ARCT-021 on Day 0, a second dose of ARCT-021 on Day 28 and on Day 208 either one dose of ARCT-021 or one dose of placebo
Biological: ARCT-021 two higher dose priming
Biological: Randomized booster
Study Group 4, Older Adult Participants
Placebo Comparator
Participants will receive one dose of Placebo (saline) on Day 0, a second dose of Placebo on Day 28 and a third dose of Placebo on Day 208
Biological: Placebo (two doses), priming
Biological: Placebo booster
ARCT-021 two lower dose priming
Biological
ARCT-021 lower dose (two doses, Day 0 and Day 28)
Study Group 2, Older Adult Participants
Study Group 2, Younger Adult Participants
ARCT-021 two higher dose priming
Biological
ARCT-021 higher dose (two doses, Day 0 and Day 28)
Study Group 3, Older Adult Participants
Study Group 3, Younger Adult Participants
Placebo (two doses), priming
Biological
Placebo (two doses, Day 0 and Day 28)
Study Group 4, Older Adult Participants
Study Group 4, Younger Adult Participants
Randomized booster
Biological
ARCT-021 (single dose) OR placebo, booster
Study Group 1, Older Adult Participants
Study Group 1, Younger Adult Participants
Study Group 2, Older Adult Participants
Study Group 2, Younger Adult Participants
Study Group 3, Older Adult Participants
Study Group 3, Younger Adult Participants
Placebo booster
Biological
Placebo (single dose)
Study Group 4, Older Adult Participants
Study Group 4, Younger Adult Participants
Per prespecified analysis, solicited systemic adverse events were defined as fever, headache, fatigue, myalgia, arthralgia, nausea, chills, diarrhea, dizziness, and vomiting. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
For 7 days post booster dose administration (Day 208 up to Day 215)
Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination
An unsolicited AE was defined as any AE (serious and nonserious) occurring after administration of first dose of study vaccine and before the end of study. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
28 days following each dose administration (Day 0 up to Day 28 for Vaccination 1 and Day 29 up to Day 56 for Vaccination 2)
Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Booster Vaccination
An unsolicited AE was defined as any AE (serious and nonserious) occurring after administration of first dose of study vaccine and before the end of study. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
28 days following each dose administration (Day 208 up to 236 days)
Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination
SAEs were defined as any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, resulted in a congenital anomaly or birth defect, or was an important medical event. An NOCD was defined as any AE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Up to Day 207
Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination
SAEs were defined as any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, resulted in a congenital anomaly or birth defect, or was an important medical event. An NOCD was defined as an AE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Day 208 to early termination (up to 396 days)
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies Post Priming Vaccination
Day 1
GMT of SARS-CoV-2 Neutralizing Antibodies Post Priming Vaccination
Day 56
GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination
Day 208
GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination
Day 236
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Priming Vaccination
GMFR is reported as a ratio to baseline (Day 0).
Day 56
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination
GMFR is reported as a ratio to baseline (Day 0).
Day 208
GMFR in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination
GMFR is reported as a ratio to baseline (Day 0).
Day 236
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56
Baseline up to Day 56
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208
Baseline up to Day 208
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236
Baseline up to Day 236
Day 208 and 236
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56
Day 56
Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels
Day 56
Tucson
Arizona
85741
United States
Arcturus Investigational Site 112
San Diego
California
92108
United States
Arcturus Investigational Site 104
Melbourne
Florida
32934
United States
Arcturus Investigational Site 105
Orlando
Florida
32806
United States
Arcturus Investigational Site 106
Pinellas Park
Florida
33781
United States
Arcturus Investigational Site 109
The Villages
Florida
32162
United States
Arcturus Investigational Site 101
Peoria
Illinois
61614
United States
Arcturus Investigational Site 110
Rockville
Maryland
20850
United States
Arcturus Investigational Site 102
Anderson
South Carolina
29621
United States
Arcturus Investigational Site 111
Austin
Texas
78705
United States
Arcturus Investigational Site 108
Dallas
Texas
75234
United States
Arcturus Investigational Site 204
Singapore
117599
Singapore
Arcturus Investigational Site 201
Singapore
169608
Singapore
Arcturus Investigational Site 203
Singapore
308433
Singapore
FG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
FG002
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
FG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
FG000146 subjects
FG001145 subjects
FG002145 subjects
FG003145 subjects
Received Vaccination 1
FG000146 subjects
FG001145 subjects
FG002144 subjects
FG003145 subjects
Received Vaccination 2
FG000132 subjects
FG001135 subjects
FG002139 subjects
FG003139 subjects
Received Booster Vaccination
FG00051 subjects
FG00160 subjects
FG00258 subjects
FG0031 subjects
Booster - ARCT-021 5 mcg
FG00013 subjects
FG00116 subjects
FG00215 subjects
FG0030 subjects
Booster - ARCT-154 5 mcg
FG00012 subjects
FG00115 subjects
FG00214 subjects
FG0030 subjects
Booster - ARCT-165 5 mcg
FG00014 subjects
FG00114 subjects
FG00214 subjects
FG0030 subjects
Booster - Placebo
FG00012 subjects
FG00114 subjects
FG00215 subjects
FG0030 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG000146 subjects
FG001145 subjects
FG002145 subjects
FG003145 subjects
Type
Comment
Reasons
Physician Decision
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
Lost to Follow-up
FG00014 subjects
FG00112 subjects
FG0028 subjects
FG0035 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Other than specified
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Participant unblinded between Day 98 and 198
FG0006 subjects
FG0015 subjects
FG0024 subjects
FG00391 subjects
Vaccine not Administered
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Protocol Violation
FG00018 subjects
FG00123 subjects
FG00212 subjects
FG00320 subjects
Withdrawal by Subject
FG00045 subjects
FG00146 subjects
FG00246 subjects
FG00327 subjects
Study Terminated by Sponsor
FG00059 subjects
FG00159 subjects
FG00271 subjects
FG0031 subjects
Safety Set included all participants who received at least 1 dose of priming study vaccine (ARCT-021 or placebo). Participants were analyzed according to the vaccine received at the time of priming or booster vaccination. One participant who was randomized to group A received treatment dosing and schedule for group D due to a dosing error. This participant is included in group D for the safety set.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
BG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
BG002
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
BG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000145
BG001144
BG002145
BG003146
BG004580
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
BG00048.9± 16.15
BG00149.9± 15.16
BG00248.2± 17.08
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00070
BG00171
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00014
BG00122
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0012
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
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Each Priming Vaccination
Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
The Reactogenicity analysis set included all participants who received any dose of priming study vaccine (ARCT-021 or placebo) and provided at least 1 reactogenicity diary report for the time period evaluated. Here, number analyzed signifies those participants who were evaluable in specified categories only.
Posted
Number
percentage of participants
For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2)
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG002
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Units
Counts
Participants
OG000142
OG001142
OG002144
OG003
Title
Denominators
Categories
Vaccination 1: Pain
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002144
ParticipantsOG003
Primary
Percentage of Participants Reporting Solicited Local Adverse Events Within 7 Days Post Booster Vaccination
Per prespecified analysis, solicited local adverse events were defined as pain, erythema, swelling, or injection site tenderness. Solicited adverse reactions were recorded by the participant in an eDiary. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
The Booster Reactogenicity analysis set included all participants who received any dose of booster vaccination (ARCT-021, ARCT-145, ARCT-156 or placebo) and provided at least 1 diary entry for the time period evaluated. Participants were analyzed according to the vaccine actually received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable in specified categories only.
Posted
Number
percentage of participants
For 7 days following each dose administration (Day 208 up to Day 215)
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
Primary
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Each Priming Vaccination
Per prespecified analysis, solicited systemic adverse events were defined as fever, headache, fatigue, myalgia, arthralgia, nausea, chills, diarrhea, dizziness, and vomiting. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
The Reactogenicity analysis set included all participants who received any dose of priming study vaccine (ARCT-021 or placebo) and provided at least 1 reactogenicity diary report for the time period evaluated. Here, number analyzed signifies those participants who were evaluable in specified categories only.
Posted
Number
percentage of participants
For 7 days following each dose administration (Day 0 up to Day 7 for Vaccination 1 and Day 29 up to Day 35 for Vaccination 2)
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Primary
Percentage of Participants Reporting Solicited Systemic Adverse Events Within 7 Days Post Booster Vaccination
Per prespecified analysis, solicited systemic adverse events were defined as fever, headache, fatigue, myalgia, arthralgia, nausea, chills, diarrhea, dizziness, and vomiting. Per prespecified analysis, solicited adverse events were not evaluated for severity (such as, serious or non-serious). A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
The Booster Reactogenicity analysis set included all participants who received any dose of booster vaccination (ARCT-021, ARCT-145, ARCT-156 or placebo) and provided at least 1 diary entry for the time period evaluated. Participants were analyzed according to the vaccine actually received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable in specified categories only.
Posted
Number
percentage of participants
For 7 days post booster dose administration (Day 208 up to Day 215)
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
Primary
Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Each Priming Vaccination
An unsolicited AE was defined as any AE (serious and nonserious) occurring after administration of first dose of study vaccine and before the end of study. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Safety Set included all participants who received at least 1 dose of priming study vaccine (ARCT-021 or placebo). Participants were analyzed according to the vaccine received at the time of priming or booster vaccination. One participant who was randomized to group A received treatment dosing and schedule for group D due to a dosing error. This participant is included in group D for the safety set.
Posted
Number
percentage of participants
28 days following each dose administration (Day 0 up to Day 28 for Vaccination 1 and Day 29 up to Day 56 for Vaccination 2)
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Primary
Percentage of Participants Reporting Unsolicited Adverse Events Up to 28 Days Post Booster Vaccination
An unsolicited AE was defined as any AE (serious and nonserious) occurring after administration of first dose of study vaccine and before the end of study. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Booster Safety Set included all participants who received at least 1 dose of booster study vaccine (ARCT-021, ARCT-154, ARCT-165, or placebo) or had safety data collected in the period following booster administration.
Posted
Number
percentage of participants
28 days following each dose administration (Day 208 up to 236 days)
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
OG002
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Primary
Percentage of Participants Reporting Treatment-Emergent Serious Adverse Events (SAE), Medically Attended Adverse Events (MAAE) and New Onset of Chronic Disease (NOCD) Post Each Priming Vaccination
SAEs were defined as any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, resulted in a congenital anomaly or birth defect, or was an important medical event. An NOCD was defined as any AE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Safety Set included all participants who received at least 1 dose of priming study vaccine (ARCT-021 or placebo). Participants were analyzed according to the vaccine received at the time of priming or booster vaccination. One participant who was randomized to group A received treatment dosing and schedule for group D due to a dosing error. This participant is included in group D for the safety set.
Posted
Number
percentage of participants
Up to Day 207
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Primary
Percentage of Participants Reporting Treatment-emergent Serious Adverse Events, Medically Attended Adverse Events and New Onset of Chronic Disease Post Booster Vaccination
SAEs were defined as any event that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, resulted in a congenital anomaly or birth defect, or was an important medical event. An NOCD was defined as an AE that led to the new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. An MAAE was an AE that led to an unscheduled visit (including a telemedicine visit) to a healthcare practitioner. A summary of all unsolicited adverse events and solicited adverse events regardless of causality is located in the Reported Adverse Events module.
Booster Safety Set included all participants who received at least 1 dose of booster study vaccine (ARCT-021, ARCT-154, ARCT-165, or placebo) or had safety data collected in the period following booster administration.
Posted
Number
percentage of participants
Day 208 to early termination (up to 396 days)
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
Primary
Geometric Mean Titer (GMT) of Serum Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibodies Post Priming Vaccination
Modified intent to treat (mITT) analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. The mITT analysis set was analyzed according to vaccine received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Geometric Mean
95% Confidence Interval
IU/mL
Day 1
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG002
Treatment C
Primary
GMT of SARS-CoV-2 Neutralizing Antibodies Post Priming Vaccination
mITT Analysis Set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. The mITT analysis set was analyzed according to vaccine received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 56
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG002
Treatment C
Primary
GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination
Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 208
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
OG002
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Treatment H1
Participants in this group received placebo at Day 208.
Primary
GMT of SARS-CoV-2 Neutralizing Antibodies Post Booster Vaccination
Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Geometric Mean
95% Confidence Interval
Titer
Day 236
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
OG002
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Treatment H1
Participants in this group received placebo at Day 208.
Primary
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Priming Vaccination
GMFR is reported as a ratio to baseline (Day 0).
mITT Analysis Set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. The mITT analysis set was analyzed according to vaccine received. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 56
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG002
Primary
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination
GMFR is reported as a ratio to baseline (Day 0).
Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 208
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
OG002
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Treatment H1
Participants in this group received placebo at Day 208.
Primary
GMFR in SARS-CoV-2 Neutralizing Antibody Titers Post Booster Vaccination
GMFR is reported as a ratio to baseline (Day 0).
Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 236
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
OG002
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Treatment H1
Participants in this group received placebo at Day 208.
Primary
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 56
mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Number
percentage of participants
Baseline up to Day 56
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG002
Treatment C
Primary
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 208
Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Number
percentage of participants
Baseline up to Day 208
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
OG002
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Treatment H1
Participants in this group received placebo at Day 208.
Primary
Percentages of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Serum Neutralizing Antibody Levels at Day 236
Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Number
percentage of participants
Baseline up to Day 236
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
OG002
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Treatment H1
Participants in this group received placebo at Day 208.
Secondary
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Priming Vaccination
mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only and number analyzed signifies those participants who were evaluable at specified time points only.
Posted
Geometric Mean
95% Confidence Interval
Binding antibody units/milliliters
Days 0 and 56
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG002
Secondary
Geometric Mean Concentration of SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Post Booster Vaccination
Booster mITT Analysis Set included all mITT participants who had at least 1 immunogenicity data evaluable by the assay in use with valid results during the booster vaccination period. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only and number analyzed signifies those participants who were evaluable at specified time points only.
Posted
Geometric Mean
95% Confidence Interval
Binding antibody units/milliliters
Day 208 and 236
ID
Title
Description
OG000
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
OG001
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
OG002
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Treatment H1
Participants in this group received placebo at Day 208.
Secondary
Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels Before Vaccination to Day 56
mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 56
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG002
Treatment C
Secondary
Percentage of Participants Achieving Greater Than or Equal to 2-fold and 4-fold Increase From Before Vaccination (Baseline) in SARS-CoV-2 Anti-S1, Anti-RBD, and Anti-N Binding Antibody Levels
mITT analysis set included all participants who received at least 1 dose of study vaccine and who had pre- and post-vaccination immunogenicity data evaluable by the assay in use with valid results for the relevant time point. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure only.
Posted
Number
95% Confidence Interval
percentage of participants
Day 56
ID
Title
Description
OG000
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG002
Treatment C
Time Frame
Vaccination 1 and 2: Day 1 up to Day 207; Booster Vaccination: Day 208 to early termination (up to 396 days). Groups E-H1 also include participants who did not receive booster dose. As pre-specified, if a participant didn't receive booster dose but had safety data collected for the booster vaccination period, the participant was included in the placebo booster group for summarization (Group H1).
Description
Trt. A, B, C, D: Safety population. 1 participant in group A moved to group D in safety set due to not receiving correct dose. Trt. E1, F1, G1, H1: Booster Safety population. For Reactogenicity analysis, solicited AEs were documented by the participant in an eDiary, not assessed as serious or nonserious, and reported below in "Other" (Not Including Serious) Adverse Events.Unsolicited AEs are reported in Serious Adverse Events or "Other" (Not Including Serious) Adverse Events as assessed by PI.
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
Treatment A
Participants in this group received ARCT-021 7.5 micrograms (mcg) at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
0
145
0
145
49
145
EG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
0
144
3
144
15
144
EG002
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
0
145
1
145
27
145
EG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
0
146
3
146
11
146
EG004
Treatment E1
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
0
44
0
44
10
44
EG005
Treatment F1
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
0
41
0
41
9
41
EG006
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
0
42
1
42
11
42
EG007
Treatment H1
Participants in this group received placebo at Day 208.
0
99
0
99
19
99
EG008
Treatment A - Reactogenicity Analysis
Participants in this group received ARCT-021 7.5 mcg at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
0
142
0
142
113
142
EG009
Treatment B - Reactogenicity Analysis
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
0
142
0
142
107
142
EG010
Treatment C - Reactogenicity Analysis
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
0
144
0
144
120
144
EG011
Treatment D - Reactogenicity Analysis
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
0
146
0
146
30
146
EG012
Treatment E1 - Reactogenicity Analysis
Participants in this group received booster dose of ARCT-021 5 mcg at Day 208.
0
43
0
43
35
43
EG013
Treatment F1- Reactogenicity Analysis
Participants in this group received booster dose of ARCT-154 5 mcg at Day 208.
0
38
0
38
25
38
EG014
Treatment G1 - Reactogenicity Analysis
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
0
38
0
38
28
38
EG015
Treatment H1 - Reactogenicity Analysis
Participants in this group received placebo at Day 208.
0
39
0
39
10
39
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA v24.1
Systematic Assessment
EG0000 affected145 at risk
EG0011 affected144 at risk
EG0020 affected145 at risk
EG0030 affected146 at risk
EG0040 affected44 at risk
EG0050 affected41 at risk
EG0060 affected42 at risk
EG0070 affected99 at risk
EG0080 affected142 at risk
EG0090 affected142 at risk
EG0100 affected144 at risk
EG0110 affected146 at risk
EG0120 affected43 at risk
EG0130 affected38 at risk
EG0140 affected38 at risk
EG0150 affected39 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v24.1
Systematic Assessment
EG0000 affected145 at risk
EG0011 affected144 at risk
EG0020 affected145 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA v24.1
Systematic Assessment
EG0000 affected145 at risk
EG0011 affected144 at risk
EG0020 affected145 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA v24.1
Systematic Assessment
EG0000 affected145 at risk
EG0010 affected144 at risk
EG0020 affected145 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Treatment H1
Participants in this group received placebo at Day 208.
Units
Counts
Participants
OG00041
OG00136
OG00238
OG00339
Title
Denominators
Categories
Pain
Title
Measurements
OG00051.2
OG00136.8
OG00239.5
OG0035.1
Erythema (Redness)
Title
Measurements
OG0009.3
OG0017.9
OG0027.9
OG003
Swelling (Hardness)
Title
Measurements
OG00011.6
OG0015.3
OG0027.9
OG003
Injection Site Tenderness
Title
Measurements
OG00081.4
OG00165.8
OG00273.7
OG003
OG002
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Units
Counts
Participants
OG000142
OG001142
OG002144
OG003146
Title
Denominators
Categories
Vaccination 1: Fever
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002143
ParticipantsOG003146
Title
Measurements
OG0004.2
OG0012.1
OG0022.8
OG003
Vaccination 1: Headache
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002144
ParticipantsOG003146
Vaccination 1: Fatigue
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002144
ParticipantsOG003145
Vaccination 1: Myalgia
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002144
ParticipantsOG003145
Vaccination 1: Arthralgia
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002144
ParticipantsOG003145
Vaccination 1: Nausea
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002144
ParticipantsOG003145
Vaccination 1: Chills
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002144
ParticipantsOG003145
Vaccination 1: Diarrhea
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002144
ParticipantsOG003145
Vaccination 1: Dizziness
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002144
ParticipantsOG003145
Vaccination 1: Vomiting
ParticipantsOG000142
ParticipantsOG001142
ParticipantsOG002144
ParticipantsOG003145
Vaccination 2: Fever
ParticipantsOG000123
ParticipantsOG001129
ParticipantsOG002131
ParticipantsOG003134
Vaccination 2: Headache
ParticipantsOG000127
ParticipantsOG001130
ParticipantsOG002136
ParticipantsOG003135
Vaccination 2: Fatigue
ParticipantsOG000127
ParticipantsOG001130
ParticipantsOG002136
ParticipantsOG003135
Vaccination 2: Myalgia
ParticipantsOG000127
ParticipantsOG001130
ParticipantsOG002136
ParticipantsOG003135
Vaccination 2: Arthralgia
ParticipantsOG000127
ParticipantsOG001130
ParticipantsOG002136
ParticipantsOG003135
Vaccination 2: Nausea
ParticipantsOG000127
ParticipantsOG001130
ParticipantsOG002136
ParticipantsOG003135
Vaccination 2: Chills
ParticipantsOG000127
ParticipantsOG001130
ParticipantsOG002136
ParticipantsOG003135
Vaccination 2: Diarrhea
ParticipantsOG000127
ParticipantsOG001130
ParticipantsOG002136
ParticipantsOG003135
Vaccination 2: Dizziness
ParticipantsOG000127
ParticipantsOG001130
ParticipantsOG002136
ParticipantsOG003135
Vaccination 2: Vomiting
ParticipantsOG000127
ParticipantsOG001130
ParticipantsOG002136
ParticipantsOG003135
OG002
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Treatment H1
Participants in this group received placebo at Day 208.
Units
Counts
Participants
OG00041
OG00135
OG00238
OG00338
Title
Denominators
Categories
Fever
ParticipantsOG00040
ParticipantsOG00134
ParticipantsOG00237
ParticipantsOG00337
Title
Measurements
OG00011.6
OG0010
OG0025.3
OG003
Headache
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00238
ParticipantsOG00338
Fatigue
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00238
ParticipantsOG00338
Myalgia
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00238
ParticipantsOG00338
Arthralgia
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00238
ParticipantsOG00338
Nausea
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00238
ParticipantsOG00338
Chills
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00238
ParticipantsOG00338
Diarrhea
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00238
ParticipantsOG00338
Dizziness
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00238
ParticipantsOG00338
Vomiting
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00238
ParticipantsOG00338
OG002
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Units
Counts
Participants
OG000145
OG001144
OG002145
OG003146
Title
Denominators
Categories
Vaccination 1
ParticipantsOG000145
ParticipantsOG001144
ParticipantsOG002145
ParticipantsOG003146
Title
Measurements
OG00020.7
OG00122.2
OG00217.9
OG003
Vaccination 2
ParticipantsOG000131
ParticipantsOG001134
ParticipantsOG002140
ParticipantsOG003140
Treatment H1
Participants in this group received placebo at Day 208.
Units
Counts
Participants
OG00044
OG00141
OG00242
OG00399
Title
Denominators
Categories
Title
Measurements
OG00015.9
OG00114.6
OG00211.9
OG0039.1
OG001
Treatment B
Participants in this group received ARCT-021 5 mcg at Day 0 and ARCT-021 5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG002
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Units
Counts
Participants
OG000145
OG001144
OG002145
OG003146
Title
Denominators
Categories
Any SAEs
Title
Measurements
OG0000
OG0012.1
OG0020.7
OG0032.1
Any MAAEs
Title
Measurements
OG00016.6
OG00120.8
OG00218.6
OG003
Any NOCDs
Title
Measurements
OG0004.1
OG0017.6
OG0022.8
OG003
OG002
Treatment G1
Participants in this group received booster dose of ARCT-165 5 mcg at Day 208.
OG003
Treatment H1
Participants in this group received placebo at Day 208.
Units
Counts
Participants
OG00044
OG00141
OG00242
OG00399
Title
Denominators
Categories
Any SAEs
Title
Measurements
OG0000
OG0010
OG0022.4
OG0030
Any MAAEs
Title
Measurements
OG00011.4
OG00119.5
OG00211.9
OG003
Any NOCDs
Title
Measurements
OG0002.3
OG0014.9
OG0020
OG003
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Units
Counts
Participants
OG000131
OG001140
OG002134
OG003141
Title
Denominators
Categories
Title
Measurements
OG0004.40(4.03 to 4.80)
OG0015.14(4.47 to 5.90)
OG0025.31(4.57 to 6.18)
OG0034.75(4.30 to 5.25)
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Units
Counts
Participants
OG000114
OG001116
OG002117
OG003116
Title
Denominators
Categories
Title
Measurements
OG0005.47(4.61 to 6.48)
OG00113.37(10.65 to 16.79)
OG00215.31(11.89 to 19.72)
OG0034.21(3.89 to 4.57)
Units
Counts
Participants
OG00041
OG00135
OG00237
OG00349
Title
Denominators
Categories
Title
Measurements
OG00013.37(7.84 to 22.80)
OG00120.71(10.47 to 40.97)
OG00214.04(7.14 to 27.62)
OG00311.84(7.57 to 18.51)
Units
Counts
Participants
OG00040
OG00135
OG00235
OG00334
Title
Denominators
Categories
Title
Measurements
OG000229.70(135.70 to 388.80)
OG001503.18(296.57 to 853.72)
OG002380.77(249.24 to 581.71)
OG00310.73(6.56 to 17.56)
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Units
Counts
Participants
OG000114
OG001116
OG002117
OG003116
Title
Denominators
Categories
Title
Measurements
OG0001.3(1.1 to 1.6)
OG0012.7(2.2 to 3.5)
OG0022.9(2.2 to 3.7)
OG0030.9(0.8 to 1.0)
Units
Counts
Participants
OG00041
OG00135
OG00237
OG00349
Title
Denominators
Categories
Title
Measurements
OG0002.4(1.3 to 4.6)
OG0014.2(2.1 to 8.3)
OG0023.0(1.6 to 5.7)
OG0032.0(1.5 to 2.8)
Units
Counts
Participants
OG00040
OG00135
OG00235
OG00334
Title
Denominators
Categories
Title
Measurements
OG00041.3(22.0 to 77.7)
OG001100.8(59.6 to 170.5)
OG00286.1(58.8 to 126.1)
OG0031.7(1.3 to 2.1)
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Units
Counts
Participants
OG000114
OG001116
OG002117
OG003116
Title
Denominators
Categories
>=2-fold Increase from Baseline
Title
Measurements
OG00015.8
OG00159.5
OG00262.4
OG0032.6
>=4-fold Increase from Baseline
Title
Measurements
OG0008.8
OG00143.1
OG00242.7
OG003
Units
Counts
Participants
OG00041
OG00135
OG00237
OG00349
Title
Denominators
Categories
>=2-fold Increase from Baseline
Title
Measurements
OG00053.7
OG00174.3
OG00248.6
OG00353.1
>=4-fold Increase from Baseline
Title
Measurements
OG00026.8
OG00125.7
OG00221.6
OG003
Units
Counts
Participants
OG00040
OG00135
OG00235
OG00334
Title
Denominators
Categories
>=2-fold Increase from Baseline
Title
Measurements
OG00090.0
OG00197.1
OG002100
OG00350.0
>=4-fold Increase from Baseline
Title
Measurements
OG00085.0
OG00194.3
OG002100
OG003
Treatment C
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Units
Counts
Participants
OG000131
OG001140
OG002133
OG003141
Title
Denominators
Categories
Anti-N: Day 0
ParticipantsOG000131
ParticipantsOG001140
ParticipantsOG002133
ParticipantsOG003141
Title
Measurements
OG0000.27(0.21 to 0.35)
OG0010.26(0.20 to 0.33)
OG0020.29(0.22 to 0.37)
OG003
Anti-N: Day 56
ParticipantsOG000114
ParticipantsOG001115
ParticipantsOG002117
ParticipantsOG003116
Anti-RBD: Day 0
ParticipantsOG000131
ParticipantsOG001140
ParticipantsOG002133
ParticipantsOG003141
Anti-RBD: Day 56
ParticipantsOG000114
ParticipantsOG001115
ParticipantsOG002117
ParticipantsOG003116
Anti-S1: Day 0
ParticipantsOG000131
ParticipantsOG001140
ParticipantsOG002133
ParticipantsOG003141
Anti-S1: Day 56
ParticipantsOG000114
ParticipantsOG001115
ParticipantsOG002117
ParticipantsOG003116
Units
Counts
Participants
OG00041
OG00135
OG00236
OG00349
Title
Denominators
Categories
Anti- N: Day 208
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00236
ParticipantsOG00349
Title
Measurements
OG0000.39(0.22 to 0.66)
OG0010.38(0.22 to 0.66)
OG0020.43(0.23 to 0.79)
OG003
Anti-N: Day 236
ParticipantsOG00040
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00334
Anti- S1: Day 208
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00236
ParticipantsOG00349
Anti- S1: Day 236
ParticipantsOG00040
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00334
Anti- RBD: Day 208
ParticipantsOG00041
ParticipantsOG00135
ParticipantsOG00236
ParticipantsOG00349
Anti- RBD: Day 236
ParticipantsOG00040
ParticipantsOG00135
ParticipantsOG00235
ParticipantsOG00334
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
Units
Counts
Participants
OG000114
OG001115
OG002117
OG003116
Title
Denominators
Categories
Anti-N
Title
Measurements
OG0000.9(0.8 to 0.9)
OG0010.9(0.8 to 1.0)
OG0020.9(0.8 to 1.0)
OG0030.9(0.9 to 1.0)
Anti-RBD
Title
Measurements
OG0008.6(6.3 to 11.8)
OG00142.7(32.0 to 57.0)
OG00248.7(34.3 to 69.3)
OG003
Anti-S1
Title
Measurements
OG00019.8(14.8 to 26.4)
OG00165.9(50.3 to 86.5)
OG00277.7(55.2 to 109.4)
OG003
Participants in this group received ARCT-021 7.5 mcg at Day 0 and ARCT-021 7.5 mcg at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.
OG003
Treatment D
Participants in this group received placebo matched to ARCT-021 at Day 0 and placebo matched to ARCT-021 at Day 28. Participants who did not otherwise have any contraindications to additional study vaccinations were randomly assigned to ARCT-021, ARCT-154, ARCT-165, or placebo for a third (booster) dose of study vaccine given at Day 208.