ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2
Official Title
Evaluation of the Immunogenicity, Safety, and Tolerability of a Single Dose of ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2: a Phase 3 Trial in Two Parts
Acronym
Not provided
Organization
Bavarian NordicINDUSTRY
Status Module
Record Verification Date
Dec 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Aug 30, 2022Actual
Primary Completion Date
Mar 15, 2023Actual
Completion Date
Oct 5, 2023Actual
First Submitted Date
Mar 25, 2022
First Submission Date that Met QC Criteria
Apr 7, 2022
First Posted Date
Apr 14, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Mar 19, 2024
Results First Submitted that Met QC Criteria
Feb 21, 2025
Results First Posted Date
Feb 24, 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
Feb 21, 2025
Last Update Posted Date
Feb 24, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bavarian NordicINDUSTRY
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
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This trial is composed of a randomized, double-blind, active controlled component (Part A) and an open-label, single-arm component (Part B) conducted in parallel.
Part A is designed to compare vaccination with a single 100 µg dose of ABNCoV2 to a single 30 µg adult booster dose of Comirnaty (active control) in adult subjects who either previously completed primary vaccination (Cohort 1) or have already received 1 booster dose (Cohort 2) of SARS-CoV-2 locally authorized vaccine(s), and whose last locally authorized SARS-CoV-2 vaccination was at least 3 months prior to the screening visit. Subjects will be randomized in a 1:1 ratio to receive either ABNCoV2 or Comirnaty.
Part B is designed to collect ABNCoV2 safety and tolerability data from a larger population of adult subjects, as well as additional immunogenicity data from a subset. Part B involves vaccination with the same single 100 µg dose of ABNCoV2 in the same population of adult subjects as the randomized component, and subjects will similarly be enrolled into 2 cohorts according to whether they have completed primary vaccination only or primary plus booster vaccination.
Detailed Description
Not provided
Conditions Module
Conditions
COVID-19 Disease
Keywords
Not provided
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
4,205Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ABNCoV2 100μg single dose
Experimental
ABNCoV2 100μg single dose
Biological: ABNCoV2
Comirnaty
Active Comparator
Comirnaty
Biological: Comirnaty
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ABNCoV2
Biological
ABNCoV2 100μg single dose
ABNCoV2 100μg single dose
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination
The primary endpoint was SARS-CoV-2 index virus (Wuhan wild type isolate) neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination).
2 weeks after the single trial vaccination occurring on Day 1
Secondary Outcomes
Measure
Description
Time Frame
Neutralizing Antibody Titers Against the SARS-CoV-2 Variants of Concern (Omicron Variants BA.4/BA.5 and XBB.1.5) at 2 Weeks After Trial Vaccination
The secondary endpoint was SARS-CoV-2 variants of concern (Omicron Variant BA.4/BA.5 and XBB.1.5) pseudovirus or virus neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years at screening.
Documented, previous completion of a primary vaccination regimen with locally authorized SARS-CoV-2 vaccine(s) or completion of primary plus 1 boost vaccination, with last vaccination at least 3 months before screening. "Locally authorized" SARS-CoV-2 vaccines are those that have received market approval or emergency use authorization in the country of enrollment.
Absence of acute medical illness, significant physical exam findings, or laboratory abnormalities, as determined by the investigator.
Informed consent, provided by the subject prior to performance of any trial-specific procedures; the subject has read, signed, and dated an informed consent form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
Body mass index (BMI) ≥18.5 and <40.
For female subjects of childbearing potential (WOCBP) and male subjects who are sexually active with a WOCBP, agreement to use an effective method of birth control from at least 30 days prior to administration of the vaccine until 30 days after the vaccination. A woman is considered of childbearing potential unless post-menopausal (defined as ≥12 months without a menstrual period at screening) or surgically sterilized (bilateral oophorectomy, bilateral tubal ligation, hysterectomy). Acceptable contraception methods are restricted to abstinence (only acceptable if refraining from heterosexual intercourse during the period of 30 days prior to administration of the vaccine until 30 days after the vaccination), double barrier contraceptives, vasectomy, intrauterine contraceptive devices, or licensed hormonal products.
For WOCBP, a negative serum pregnancy test at screening.
Negative tests for human immunodeficiency virus antibody (anti HIV), hepatitis B surface antigen (HBsAG), and antibody to hepatitis C virus (HCV).
Exclusion Criteria:
History of COVID 19 infection within the last 3 months before screening.
Previous vaccination with a SARS-CoV-2 vaccine other than those mentioned in inclusion criterion #2.
Positive test for SARS-CoV-2 infection at screening.
Breastfeeding with intent to continue.
Acute or chronic medical condition that, in the opinion of the investigator, would render the trial procedures unsafe or would interfere with the evaluation of the responses.
Known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome.
History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months prior to screening that is considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous tumor site.
Laboratory parameters (such as complete blood count, serum biochemistry including aspartate aminotransferase [AST], alanine amino transferase [ALT], alkaline phosphokinase [ALP], bilirubin, or creatinine values), pulse rate, or blood pressure outside normal range at screening and deemed clinically relevant by the investigator.
Clinically significant mental disorder not adequately controlled by medical treatment.
Active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
History of anaphylaxis or severe allergic reaction to any vaccine.
History of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination.
History of any vaccinations or plan to receive any vaccinations with a non-live vaccine within 14 days prior to or after trial vaccination.
Recent blood donation (including platelets, plasma and red blood cells) within 4 weeks prior to screening, or planned blood donations during the active phase of the trial.
Chronic systemic administration (defined as more than 14 days) of >5 mg prednisone (or equivalent)/day, or any other immune-modifying drugs during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed.
History of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy.
Administration or planned administration of immunoglobulins and/or any blood products during a period starting 3 months prior to administration of the vaccine and ending 4 weeks after vaccination. Receipt of packed red blood cells given for an emergency indication in an otherwise healthy person, and not required as ongoing treatment is not exclusionary (for example packed red blood cells given in emergency during an elective surgery).
Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the administration of trial vaccine, or planned administration of such a drug or vaccine throughout the trial.
Involvement in this trial as site personnel.
Known bleeding disorder that, in the opinion of the investigator, would contraindicate intramuscular injection.
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
Name
Affiliation
Role
Leo James, MD
Bavarian Nordic
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Achieve Clinical Research LLC d/b/a Accel Research Sites
Birmingham
Alabama
35216
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Three subjects were randomized but were withdrawn prior to receiving study product. One subject withdrew consent and two subjects were randomized in error and withdrawn due to not meeting inclusion/exclusion criteria.
Recruitment Details
At least 500 subjects were to be enrolled into Part A of this trial, and approximately 3000 subjects were to be enrolled into Part B. Enrollment for Part A and Part B occurred simultaneously and enrollment was based on prior SARS-CoV-2 experience, with Cohort 1 including an authorized primary vaccination regimen; and Cohort 2 including an authorized primary vaccination regimen with a booster vaccination.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A Cohort 1 ABNCoV2
Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1
FG001
Part A Cohort 1 Comirnaty
Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1
Periods
Title
Milestones
Reasons Not Completed
Active Trial Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
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
Jun 30, 2023
Mar 15, 2024
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
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Comirnaty
Biological
Comirnaty
Comirnaty
2 weeks after the single trial vaccination occurring on Day 1
Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination [Time Frame: 2 Weeks After the Single Trial Vaccination Occurring on Day 1]
The secondary endpoint was SARS-CoV-2 index virus (Wuhan wild type isolate) neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part B Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part B Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination).
2 weeks after the single trial vaccination occurring on Day 1
Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination.
The number and percent of subjects who report:
SAEs or AESIs assessed as related to trial vaccine during the entire trial period, which includes both the active trial phase and follow-up.
Grade 3 or higher AEs assessed as related to trial vaccine in the 8 day period starting with the day of vaccination.
SAEs, AESIs or MAAEs, regardless of relationship, during the active trial phase.
SAE, AESI or MAAEs, regardless of relationship, during the entire trial period.
Grade 3 or higher AEs assessed as related to trial vaccine during the active trial phase.
Solicited local AEs in the 8 day period starting with the day of vaccination.
Solicited general AEs in the 8 day period starting with the day of vaccination.
Solicited event grading based on FDA 2007 Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, where Grade 1 is Mild and Grade 4 is Life-Threatening and the worst outcome.
Active trial period is from vaccination until 28 to 35 days after vaccination. Entire trial period is from vaccination until 182 to 196 days after vaccination. Solicited events are reported if occurring within 8 days following vaccination.
Arizona Clinical Trials
Mesa
Arizona
85210
United States
Tucson Neuroscience Research - M3 WR
Tucson
Arizona
85710
United States
Wr-Pri, Llc
Los Alamitos
California
90720
United States
PRI, LLC - Newport Beach - M3 WR
Newport Beach
California
92660
United States
FOMAT Medical Research
Oxnard
California
93030
United States
Women's Healthcare Research Corporation
San Diego
California
92111
United States
Medical Center For Clinical Research
San Diego
California
92120
United States
Tekton Research
Fort Collins
Colorado
80525
United States
Clinical Site Partners
Leesburg
Florida
34748
United States
Accel Research Sites
Maitland
Florida
32751
United States
Suncoast Research Group LLC
Miami
Florida
33135
United States
Suncoast Research Associates LLC
Miami
Florida
33173
United States
Clinical Site Partners
Miami
Florida
33186
United States
TrueBlue Clinical Research
Tampa
Florida
33609
United States
Clinical Site Partners
Winter Park
Florida
32789
United States
Atlanta Center for Medical Research - CenExel ACMR
Bispebjerg Hospital, Afdeling for Lunge- og Infektionssygdomme
Copenhagen
2400
Denmark
Regionshospitalet Gødstrup, Medicinsk afdeling, Klinik for Infektionssygdomme
Herning
7400
Denmark
Nordsjællands Hospital, Hillerød, Lunge- og Infektionsmedicinsk Afdeling
Hillerød
3400
Denmark
Hvidovre Hospital, Infektionsmedicinsk afd.
Hvidovre
2650
Denmark
Odense Universitetshospital, Q, Infektionsmedicinsk Afdeling
Odense
5000
Denmark
Sjællands Universitetshospital
Roskilde
4000
Denmark
FG002
Part A Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
FG003
Part A Cohort 2 Comirnaty
Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1
FG004
Part B Cohort 1 ABNCoV2
Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1
FG005
Part B Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
FG00034 subjects
FG00134 subjects
FG002277 subjects
FG003277 subjects
FG0041438 subjects
FG0052145 subjects
COMPLETED
FG00034 subjects
FG00134 subjects
FG002277 subjects
FG003276 subjects
FG0041390 subjects
FG0052098 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG00448 subjects
FG00547 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
SPONSOR GUIDANCE DUE TO SUBJECT'S CHANGE IN SCHEDULE WITH TRAVELING OUT OF THE COUNTRY
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
THE PARTICIPANT HAD TO BE DROPPED FROM THE STUDY AS THEY WERE UNABLE TO CONTINUE.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
SUBJECT WAS OOW
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Follow-up Period
Type
Comment
Milestone Data
STARTED
Subject could participate in follow-up even if not completing the active trial period.
FG00034 subjects
FG00134 subjects
FG002277 subjects
FG003277 subjects
FG0041438 subjects
FG0052144 subjects
COMPLETED
FG00034 subjects
FG00133 subjects
FG002272 subjects
FG003273 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0025 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
"All subjects who received at least one vaccination with ABNCoV2 at any time during the trial. "
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A Cohort 1 ABNCoV2
Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1
BG001
Part A Cohort 1 Comirnaty
Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1
BG002
Part A Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
BG003
Part A Cohort 2 Comirnaty
Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1
BG004
Part B Cohort 1 ABNCoV2
Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1
BG005
Part B Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00034
BG00134
BG002277
BG003277
BG0041438
BG0052145
BG0064205
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00034.4± 13.44
BG00132.2± 11.67
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00112
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Belgium
Title
Measurements
BG00024
BG00126
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
Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination
The primary endpoint was SARS-CoV-2 index virus (Wuhan wild type isolate) neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination).
All subjects who are in the Safety Analysis Set, have at least a baseline and 1 post-vaccination neutralizing antibody result, and have neither intercurrent events indicative of SARSCoV2 infection nor received a booster for SARSCoV2 outside of the trial within 2 weeks of vaccination. Subjects with protocol deviations substantially affecting the immunogenicity outcomes were excluded from this analysis set.
Posted
Geometric Mean
95% Confidence Interval
titer
2 weeks after the single trial vaccination occurring on Day 1
ID
Title
Description
OG000
Part A Cohort 1 ABNCoV2
Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1
OG001
Part A Cohort 1 Comirnaty
Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1
OG002
Part A Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
OG003
Part A Cohort 2 Comirnaty
Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1
Units
Counts
Participants
OG00034
OG00133
OG002267
OG003
Title
Denominators
Categories
Title
Measurements
OG0001018.1(621.1 to 1669.0)
OG0011060.6(708.2 to 1588.3)
OG0021259.0(1125.3 to 1408.4)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is >=0.67.
Mixed Models Analysis
A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.
0.6350
P-value corresponds to Cohort 1 ABNCoV2 comparison to Cohort 1 Comirnaty
Geometric Mean Ratio
0.89
2-Sided
97.5
0.50
1.57
Secondary
Neutralizing Antibody Titers Against the SARS-CoV-2 Variants of Concern (Omicron Variants BA.4/BA.5 and XBB.1.5) at 2 Weeks After Trial Vaccination
The secondary endpoint was SARS-CoV-2 variants of concern (Omicron Variant BA.4/BA.5 and XBB.1.5) pseudovirus or virus neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part A Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part A Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination.
All subjects who are in the Safety Analysis Set, have at least a baseline and 1 post-vaccination neutralizing antibody result, and have neither intercurrent events indicative of SARSCoV2 infection nor received a booster for SARSCoV2 outside of the trial within 2 weeks of vaccination. Subjects with protocol deviations substantially affecting the immunogenicity outcomes were excluded. Part A Cohort 2 is the only group that met the primary endpoint criteria and are the only results analyzed.
Posted
Geometric Mean
95% Confidence Interval
titer
2 weeks after the single trial vaccination occurring on Day 1
ID
Title
Description
OG000
Part A Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
OG001
Part A Cohort 2 Comirnaty
Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1
Secondary
Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination [Time Frame: 2 Weeks After the Single Trial Vaccination Occurring on Day 1]
The secondary endpoint was SARS-CoV-2 index virus (Wuhan wild type isolate) neutralizing antibodies assessed at 2 weeks after trial vaccination, for subjects in the Immunogenicity Analysis Sets in Part B Cohort 1 (adult subjects who previously completed primary vaccination at least 3 months prior to the screening visit) and Part B Cohort 2 (adult subjects who have completed primary vaccination and have received 1 booster vaccination).
This secondary endpoint was defined in the protocol and originally intended to be performed on the Part B Cohorts. However, based on the assessment of Part A lower neutralizing antibody results versus the comparator it was decided not to analyze the Part B open-label samples. Due to there being no assays performed, there are no assay results to report.
Posted
2 weeks after the single trial vaccination occurring on Day 1
ID
Title
Description
OG000
Part B Cohort 1 ABNCoV2
Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1
OG001
Part B Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
Secondary
Safety and Tolerability of the ABNCoV2 Vaccine as Measured by the Frequency of Solicited and Unsolicited Adverse Events Occurring During or After the Trial Vaccination.
The number and percent of subjects who report:
SAEs or AESIs assessed as related to trial vaccine during the entire trial period, which includes both the active trial phase and follow-up.
Grade 3 or higher AEs assessed as related to trial vaccine in the 8 day period starting with the day of vaccination.
SAEs, AESIs or MAAEs, regardless of relationship, during the active trial phase.
SAE, AESI or MAAEs, regardless of relationship, during the entire trial period.
Grade 3 or higher AEs assessed as related to trial vaccine during the active trial phase.
Solicited local AEs in the 8 day period starting with the day of vaccination.
Solicited general AEs in the 8 day period starting with the day of vaccination.
Solicited event grading based on FDA 2007 Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials, where Grade 1 is Mild and Grade 4 is Life-Threatening and the worst outcome.
All subjects who received at least one vaccination with ABNCoV2 at any time during the trial.
Posted
Count of Participants
Participants
Active trial period is from vaccination until 28 to 35 days after vaccination. Entire trial period is from vaccination until 182 to 196 days after vaccination. Solicited events are reported if occurring within 8 days following vaccination.
ID
Title
Description
OG000
Part A Cohort 1 ABNCoV2
Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1
Time Frame
Overall trial from vaccination through final follow-up visit occurring between Day 182 and Day 196 after vaccination.
Description
Not provided
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
Part A Cohort 1 ABNCoV2
Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1
0
34
2
34
6
34
EG001
Part A Cohort 1 Comirnaty
Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1
0
34
0
34
4
34
EG002
Part A Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
1
277
3
277
40
277
EG003
Part A Cohort 2 Comirnaty
Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1
1
277
7
277
47
277
EG004
Part B Cohort 1 ABNCoV2
Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1
0
1,438
23
1,438
36
1,438
EG005
Part B Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
1
2,145
49
2,145
125
2,145
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Sepsis
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG0030 events0 affected277 at risk
EG0041 events1 affected1,438 at risk
EG0052 events2 affected2,145 at risk
Urinary tract infection
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Appendicitis
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Large intestine infection
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Liver abscess
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Pelvic inflammatory disease
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Dengue fever
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Intervertebral discitis
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Seizure
Nervous system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Migraine
Nervous system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Presyncope
Nervous system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected277 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Spinal cord injury cervical
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Wound necrosis
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Acoustic neuroma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Brain cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Endometrial adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Lung cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Oropharyngeal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Small cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
End stage renal disease
Renal and urinary disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Obstructive nephropathy
Renal and urinary disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Bipolar disease
Psychiatric disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Delirium tremens
Psychiatric disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Major depression
Psychiatric disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected277 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0021 events1 affected277 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Peptic ulcer haemorrhage
Gastrointestinal disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Intervertebral disc degeneration
Musculoskeletal and connective tissue disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Arterial occlusive disease
Vascular disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Blood loss anaemia
Blood and lymphatic system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Abnormal uterine bleeding
Reproductive system and breast disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Pelvic organ prolapse
Reproductive system and breast disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Astrovirus test positive
Investigations
MedDRA version 25.0
Non-systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected34 at risk
EG0020 events0 affected277 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COVID-19
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected34 at risk
EG00217 events17 affected277 at risk
EG00314 events14 affected277 at risk
EG00436 events36 affected1,438 at risk
EG005125 events125 affected2,145 at risk
Nasopharyngitis
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0002 events2 affected34 at risk
EG0010 events0 affected34 at risk
EG00215 events15 affected277 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA version 25.0
Non-systematic Assessment
EG0001 events1 affected34 at risk
EG0012 events2 affected34 at risk
EG0022 events2 affected277 at risk
EG003
Headache
Nervous system disorders
MedDRA version 25.0
Non-systematic Assessment
EG0003 events3 affected34 at risk
EG0011 events1 affected34 at risk
EG00211 events11 affected277 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Institution/Investigator agree to submit any proposed publication or presentation to Sponsor for review at least 60 days prior to submitting any such proposed publication to a publisher or proceeding with such proposed presentation. Sponsor shall have the right to require Institution/Investigator to remove specifically identified Confidential Information and/or to delay the proposed publication or presentation for an additional 60 days to enable Sponsor to seek patent protection for Inventions.
SUBJECT WAS GOING OUT OF TOWN FOR AN EXTENDED PERIOD OF TIME
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
SUBJECT NON-COMPLIANCE
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
SUBJECT MOVED OUT OF TOWN
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
EARLY TERMINATION
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
SUBJECT HAD BUT DID NOT COMPLETE THEIR FINAL VISIT WITHIN 14 DAYS BEFORE THE V1 + 182 DAYS
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
DROPPED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
DROPPED DUE TO BEING UNABLE TO CONTINUE IN THE TRIAL.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
0
BG0040
BG0050
BG0060
Between 18 and 65 years
BG00034
BG00134
BG002247
BG003249
BG0041147
BG0051356
BG0063067
>=65 years
BG0000
BG0010
BG00230
BG00328
BG004291
BG005789
BG0061138
42.8
± 16.4
BG00341.8± 15.91
BG00448.2± 15.6
BG00554.5± 15.73
BG00650.4± 16.43
133
BG003135
BG004813
BG0051210
BG0062318
Male
BG00019
BG00122
BG002144
BG003142
BG004625
BG005935
BG0061887
2
BG0033
BG004623
BG005593
BG0061222
Not Hispanic or Latino
BG00034
BG00133
BG002274
BG003274
BG004795
BG0051523
BG0062933
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG00420
BG00529
BG00650
0
BG0030
BG0046
BG00517
BG00623
Asian
BG0000
BG0010
BG0022
BG0031
BG00427
BG00559
BG00689
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0053
BG0063
Black or African American
BG0000
BG0010
BG0020
BG0031
BG004439
BG005469
BG006909
White
BG00033
BG00134
BG002272
BG003273
BG004911
BG0051521
BG0063044
More than one race
BG0000
BG0010
BG0020
BG0031
BG00414
BG00528
BG00643
Unknown or Not Reported
BG0001
BG0010
BG0023
BG0031
BG00441
BG00548
BG00694
161
BG003167
BG0040
BG0050
BG006378
United States
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041438
BG0052145
BG0063583
Denmark
Title
Measurements
BG00010
BG0018
BG002116
BG003110
BG0040
BG0050
BG006244
261
1619.6
(1485.9 to 1765.4)
Non-Inferiority
The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is >=0.67.
OG002
OG003
Formal hypothesis testing was performed due to having at least 400 evaluable subjects with primary endpoint data available at baseline and at 2 weeks after trial vaccination. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is >=0.67.
Mixed Models Analysis
A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.
0.0002
P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty
Geometric Mean Ratio
0.80
2-Sided
97.5
0.70
0.92
Non-Inferiority
The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is >=0.67.
Units
Counts
Participants
OG000265
OG001260
Title
Denominators
Categories
Omicron Variant BA.4/BA.5
Title
Measurements
OG00017112.6(14775.8 to 19818.9)
OG00123506.3(20794.5 to 26571.7)
Omicron Variant XBB.1.5
Title
Measurements
OG00054.7(48.9 to 61.3)
OG00181.3(73.1 to 90.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is >=0.67.
Mixed Models Analysis
A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.
0.0008
P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron variant BA.4/BA.5
Geometric Mean Ratio
0.76
2-Sided
97.5
0.64
0.91
Non-Inferiority
The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is >=0.67.
OG000
OG001
Formal hypothesis testing was performed due to meeting the primary endpoint success criterion in Cohort 2. The null hypothesis is that ABNCoV2 is inferior to Comirnaty and will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is >=0.67.
Mixed Models Analysis
A generalized linear model with age and baseline results included as covariates was used to compare between the vaccination groups.
<0.0001
P-value corresponds to Cohort 2 ABNCoV2 comparison to Cohort 2 Comirnaty for Omicron Variant XBB.1.5.
Geometric Mean Ratio
0.69
2-Sided
97.5
0.59
0.81
Non-Inferiority
The success criterion for the null hypothesis that ABNCoV2 is inferior to Comirnaty will be rejected if the ratio of the GMTs for ABNCoV2 versus Comirnaty is within the non-inferiority margin of 0.67; that is, the lower bound of the 2-sided 97.5% CI of the GMT ratio is >=0.67.
Units
Counts
Participants
OG0000
OG0010
OG001
Part A Cohort 1 Comirnaty
Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1
OG002
Part A Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
OG003
Part A Cohort 2 Comirnaty
Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1
OG004
Part B Cohort 1 ABNCoV2
Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1
OG005
Part B Cohort 2 ABNCoV2
Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1
Units
Counts
Participants
OG00034
OG00134
OG002277
OG003277
OG0041438
OG0052145
Title
Denominators
Categories
Related SAEs during Entire Trial Period
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Related AESIs during Entire Trial Period
Title
Measurements
OG0000
OG0010
OG0023
OG003
Related Grade 3 or Higher AEs within 8 Days of Vaccination
Title
Measurements
OG0007
OG0012
OG00228
OG003
SAE, AESI, or MAAE during Active Trial Period
Title
Measurements
OG0001
OG0013
OG00242
OG003
SAE, AESI, or MAAE during Entire Trial Period
Title
Measurements
OG0006
OG0016
OG00285
OG003
Related Grade 3 or Higher AEs during Active Trial Period
Title
Measurements
OG0007
OG0013
OG00235
OG003
Solicited Local AE within 8 Days of Vaccination
Title
Measurements
OG00028
OG00130
OG002238
OG003
Solicited Systemic AE within 8 Days of Vaccination