COVID-19 Disease
Conditions
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.
Interventions
BIOLOGICALComirnaty
Comirnaty
BIOLOGICALABNCoV2
ABNCoV2 100μg single dose
Sponsors
Bavarian Nordic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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. * History of myocarditis or pericarditis. * History of or active autoimmune disease. History of Guillain-Barré syndrome or Reye's syndrome. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination | 2 weeks after the single trial vaccination occurring on Day 1 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 weeks after the single trial vaccination occurring on Day 1 | 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. |
| 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] | 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). |
| 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. | 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. | 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. |
Countries
Belgium, Denmark, United States
Participant flow
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.
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.
Participants by arm
| Arm | Count |
|---|---|
| Part A Cohort 1 ABNCoV2 Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1 | 34 |
| Part A Cohort 1 Comirnaty Subjects who previously completed primary vaccination 30ug Comirnaty by subcutaneous injection on Day 1 | 34 |
| Part A Cohort 2 ABNCoV2 Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1 | 277 |
| Part A Cohort 2 Comirnaty Subjects who previously completed primary vaccination plus 1 booster 30ug Comirnaty by subcutaneous injection on Day 1 | 277 |
| Part B Cohort 1 ABNCoV2 Subjects who previously completed primary vaccination 100ug ABNCoV2 by subcutaneous injection on Day 1 | 1,438 |
| Part B Cohort 2 ABNCoV2 Subjects who previously completed primary vaccination plus 1 booster 100ug ABNCoV2 by subcutaneous injection on Day 1 | 2,145 |
| Total | 4,205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Active Trial Period | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 |
| Active Trial Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 32 | 28 |
| Active Trial Period | Physician Decision | 0 | 0 | 0 | 0 | 2 | 0 |
| Active Trial Period | Protocol Violation | 0 | 0 | 0 | 0 | 1 | 3 |
| Active Trial Period | SPONSOR GUIDANCE DUE TO SUBJECT'S CHANGE IN SCHEDULE WITH TRAVELING OUT OF THE COUNTRY | 0 | 0 | 0 | 0 | 0 | 1 |
| Active Trial Period | SUBJECT WAS OOW | 0 | 0 | 0 | 0 | 0 | 1 |
| Active Trial Period | THE PARTICIPANT HAD TO BE DROPPED FROM THE STUDY AS THEY WERE UNABLE TO CONTINUE. | 0 | 0 | 0 | 0 | 0 | 1 |
| Active Trial Period | Withdrawal by Subject | 0 | 0 | 0 | 1 | 12 | 13 |
| Follow-up Period | Adverse Event | 0 | 0 | 0 | 0 | 2 | 1 |
| Follow-up Period | Death | 0 | 0 | 1 | 1 | 0 | 1 |
| Follow-up Period | DROPPED | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow-up Period | DROPPED DUE TO BEING UNABLE TO CONTINUE IN THE TRIAL. | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow-up Period | EARLY TERMINATION | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow-up Period | Lost to Follow-up | 0 | 1 | 2 | 2 | 113 | 89 |
| Follow-up Period | PATIENT WORKS IN AUSTRALIA SINCE JUNE2023 | 0 | 0 | 1 | 0 | 0 | 0 |
| Follow-up Period | Physician Decision | 0 | 0 | 0 | 0 | 2 | 2 |
| Follow-up Period | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow-up Period | SUBJECT HAD BUT DID NOT COMPLETE THEIR FINAL VISIT WITHIN 14 DAYS BEFORE THE V1 + 182 DAYS | 0 | 0 | 0 | 0 | 0 | 2 |
| Follow-up Period | SUBJECT MOVED OUT OF TOWN | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow-up Period | SUBJECT NON-COMPLIANCE | 0 | 0 | 0 | 0 | 1 | 0 |
| Follow-up Period | SUBJECT WAS GOING OUT OF TOWN FOR AN EXTENDED PERIOD OF TIME | 0 | 0 | 0 | 0 | 1 | 0 |
| Follow-up Period | Withdrawal by Subject | 0 | 0 | 1 | 1 | 34 | 35 |
Baseline characteristics
| Characteristic | Part A Cohort 1 Comirnaty | Part A Cohort 2 ABNCoV2 | Part A Cohort 2 Comirnaty | Part A Cohort 1 ABNCoV2 | Part B Cohort 1 ABNCoV2 | Part B Cohort 2 ABNCoV2 | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 30 Participants | 28 Participants | 0 Participants | 291 Participants | 789 Participants | 1138 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 247 Participants | 249 Participants | 34 Participants | 1147 Participants | 1356 Participants | 3067 Participants |
| Age, Continuous | 32.2 years STANDARD_DEVIATION 11.67 | 42.8 years STANDARD_DEVIATION 16.4 | 41.8 years STANDARD_DEVIATION 15.91 | 34.4 years STANDARD_DEVIATION 13.44 | 48.2 years STANDARD_DEVIATION 15.6 | 54.5 years STANDARD_DEVIATION 15.73 | 50.4 years STANDARD_DEVIATION 16.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants | 00 Participants | 623 Participants | 593 Participants | 1222 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 274 Participants | 274 Participants | 34 Participants | 795 Participants | 1523 Participants | 2933 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 20 Participants | 29 Participants | 50 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 17 Participants | 23 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 27 Participants | 59 Participants | 89 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 439 Participants | 469 Participants | 909 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 14 Participants | 28 Participants | 43 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 41 Participants | 48 Participants | 94 Participants |
| Race (NIH/OMB) White | 34 Participants | 272 Participants | 273 Participants | 33 Participants | 911 Participants | 1521 Participants | 3044 Participants |
| Region of Enrollment Belgium | 26 participants | 161 participants | 167 participants | 24 participants | 0 participants | 0 participants | 378 participants |
| Region of Enrollment Denmark | 8 participants | 116 participants | 110 participants | 10 participants | 0 participants | 0 participants | 244 participants |
| Region of Enrollment United States | 0 participants | 0 participants | 0 participants | 0 participants | 1438 participants | 2145 participants | 3583 participants |
| Sex: Female, Male Female | 12 Participants | 133 Participants | 135 Participants | 15 Participants | 813 Participants | 1210 Participants | 2318 Participants |
| Sex: Female, Male Male | 22 Participants | 144 Participants | 142 Participants | 19 Participants | 625 Participants | 935 Participants | 1887 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 34 | 1 / 277 | 1 / 277 | 0 / 1,438 | 1 / 2,145 |
| other Total, other adverse events | 6 / 34 | 4 / 34 | 40 / 277 | 47 / 277 | 36 / 1,438 | 125 / 2,145 |
| serious Total, serious adverse events | 2 / 34 | 0 / 34 | 3 / 277 | 7 / 277 | 23 / 1,438 | 49 / 2,145 |
Outcome results
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).
Time frame: 2 weeks after the single trial vaccination occurring on Day 1
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Part A Cohort 1 ABNCoV2 | Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination | 1018.1 titer |
| Part A Cohort 1 Comirnaty | Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination | 1060.6 titer |
| Part A Cohort 2 ABNCoV2 | Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination | 1259.0 titer |
| Part A Cohort 2 Comirnaty | Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination | 1619.6 titer |
Comparison: 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.p-value: 0.63597.5% CI: [0.5, 1.57]Mixed Models Analysis
Comparison: 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.p-value: 0.000297.5% CI: [0.7, 0.92]Mixed Models Analysis
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).
Time frame: 2 weeks after the single trial vaccination occurring on Day 1
Population: 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.
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.
Time frame: 2 weeks after the single trial vaccination occurring on Day 1
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part A Cohort 1 ABNCoV2 | 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 | Omicron Variant BA.4/BA.5 | 17112.6 titer |
| Part A Cohort 1 ABNCoV2 | 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 | Omicron Variant XBB.1.5 | 54.7 titer |
| Part A Cohort 1 Comirnaty | 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 | Omicron Variant BA.4/BA.5 | 23506.3 titer |
| Part A Cohort 1 Comirnaty | 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 | Omicron Variant XBB.1.5 | 81.3 titer |
Comparison: 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.p-value: 0.000897.5% CI: [0.64, 0.91]Mixed Models Analysis
Comparison: 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.p-value: <0.000197.5% CI: [0.59, 0.81]Mixed Models Analysis
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.
Time frame: 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.
Population: All subjects who received at least one vaccination with ABNCoV2 at any time during the trial.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A Cohort 1 ABNCoV2 | 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. | Related Grade 3 or Higher AEs within 8 Days of Vaccination | 7 Participants |
| Part A Cohort 1 ABNCoV2 | 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. | Related AESIs during Entire Trial Period | 0 Participants |
| Part A Cohort 1 ABNCoV2 | 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. | Related SAEs during Entire Trial Period | 0 Participants |
| Part A Cohort 1 ABNCoV2 | 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. | SAE, AESI, or MAAE during Active Trial Period | 1 Participants |
| Part A Cohort 1 ABNCoV2 | 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. | SAE, AESI, or MAAE during Entire Trial Period | 6 Participants |
| Part A Cohort 1 ABNCoV2 | 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. | Related Grade 3 or Higher AEs during Active Trial Period | 7 Participants |
| Part A Cohort 1 ABNCoV2 | 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. | Solicited Local AE within 8 Days of Vaccination | 28 Participants |
| Part A Cohort 1 ABNCoV2 | 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. | Solicited Systemic AE within 8 Days of Vaccination | 23 Participants |
| Part A Cohort 1 Comirnaty | 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. | SAE, AESI, or MAAE during Active Trial Period | 3 Participants |
| Part A Cohort 1 Comirnaty | 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. | Solicited Systemic AE within 8 Days of Vaccination | 17 Participants |
| Part A Cohort 1 Comirnaty | 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. | Related SAEs during Entire Trial Period | 0 Participants |
| Part A Cohort 1 Comirnaty | 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. | Solicited Local AE within 8 Days of Vaccination | 30 Participants |
| Part A Cohort 1 Comirnaty | 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. | Related Grade 3 or Higher AEs during Active Trial Period | 3 Participants |
| Part A Cohort 1 Comirnaty | 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. | Related Grade 3 or Higher AEs within 8 Days of Vaccination | 2 Participants |
| Part A Cohort 1 Comirnaty | 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. | Related AESIs during Entire Trial Period | 0 Participants |
| Part A Cohort 1 Comirnaty | 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. | SAE, AESI, or MAAE during Entire Trial Period | 6 Participants |
| Part A Cohort 2 ABNCoV2 | 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. | Related AESIs during Entire Trial Period | 3 Participants |
| Part A Cohort 2 ABNCoV2 | 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. | Related Grade 3 or Higher AEs within 8 Days of Vaccination | 28 Participants |
| Part A Cohort 2 ABNCoV2 | 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. | SAE, AESI, or MAAE during Active Trial Period | 42 Participants |
| Part A Cohort 2 ABNCoV2 | 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. | Solicited Systemic AE within 8 Days of Vaccination | 185 Participants |
| Part A Cohort 2 ABNCoV2 | 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. | SAE, AESI, or MAAE during Entire Trial Period | 85 Participants |
| Part A Cohort 2 ABNCoV2 | 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. | Related Grade 3 or Higher AEs during Active Trial Period | 35 Participants |
| Part A Cohort 2 ABNCoV2 | 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. | Solicited Local AE within 8 Days of Vaccination | 238 Participants |
| Part A Cohort 2 ABNCoV2 | 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. | Related SAEs during Entire Trial Period | 0 Participants |
| Part A Cohort 2 Comirnaty | 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. | Solicited Local AE within 8 Days of Vaccination | 236 Participants |
| Part A Cohort 2 Comirnaty | 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. | Related Grade 3 or Higher AEs during Active Trial Period | 34 Participants |
| Part A Cohort 2 Comirnaty | 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. | SAE, AESI, or MAAE during Entire Trial Period | 78 Participants |
| Part A Cohort 2 Comirnaty | 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. | Related SAEs during Entire Trial Period | 0 Participants |
| Part A Cohort 2 Comirnaty | 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. | Related Grade 3 or Higher AEs within 8 Days of Vaccination | 24 Participants |
| Part A Cohort 2 Comirnaty | 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. | SAE, AESI, or MAAE during Active Trial Period | 30 Participants |
| Part A Cohort 2 Comirnaty | 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. | Solicited Systemic AE within 8 Days of Vaccination | 170 Participants |
| Part A Cohort 2 Comirnaty | 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. | Related AESIs during Entire Trial Period | 0 Participants |
| Part B Cohort 1 ABNCoV2 | 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. | Solicited Systemic AE within 8 Days of Vaccination | 715 Participants |
| Part B Cohort 1 ABNCoV2 | 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. | Related SAEs during Entire Trial Period | 0 Participants |
| Part B Cohort 1 ABNCoV2 | 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. | SAE, AESI, or MAAE during Entire Trial Period | 192 Participants |
| Part B Cohort 1 ABNCoV2 | 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. | Related Grade 3 or Higher AEs during Active Trial Period | 218 Participants |
| Part B Cohort 1 ABNCoV2 | 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. | Solicited Local AE within 8 Days of Vaccination | 810 Participants |
| Part B Cohort 1 ABNCoV2 | 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. | Related AESIs during Entire Trial Period | 6 Participants |
| Part B Cohort 1 ABNCoV2 | 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. | Related Grade 3 or Higher AEs within 8 Days of Vaccination | 164 Participants |
| Part B Cohort 1 ABNCoV2 | 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. | SAE, AESI, or MAAE during Active Trial Period | 96 Participants |
| Part B Cohort 2 ABNCoV2 | 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. | Solicited Systemic AE within 8 Days of Vaccination | 1139 Participants |
| Part B Cohort 2 ABNCoV2 | 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. | SAE, AESI, or MAAE during Entire Trial Period | 442 Participants |
| Part B Cohort 2 ABNCoV2 | 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. | Related Grade 3 or Higher AEs within 8 Days of Vaccination | 188 Participants |
| Part B Cohort 2 ABNCoV2 | 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. | SAE, AESI, or MAAE during Active Trial Period | 204 Participants |
| Part B Cohort 2 ABNCoV2 | 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. | Related Grade 3 or Higher AEs during Active Trial Period | 272 Participants |
| Part B Cohort 2 ABNCoV2 | 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. | Related AESIs during Entire Trial Period | 7 Participants |
| Part B Cohort 2 ABNCoV2 | 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. | Solicited Local AE within 8 Days of Vaccination | 1269 Participants |
| Part B Cohort 2 ABNCoV2 | 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. | Related SAEs during Entire Trial Period | 0 Participants |