COVID-19 disease MedDRA version: 23.1 Level: PT Classification code 10084457 Term: COVID-19 immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Code: ABNCoV2
Pharmaceutical Form: Dispersion for injection
INN or Proposed INN: COVID-19 Vaccine (recombinant, non-adjuvanted)
Other descriptive name: ABNCoV2
Concentration unit: µg microgram
Sponsors
Bavarian Nordic A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years at screening. 2. Documented, previous completion of a primary vaccination regimen with locally authorized SARS-CoV-2 vaccine(s) or completion of primary plus 1 boost vaccination (see definition of completed primary vaccination regimen and completed primary plus boost vaccination in Section 1.2), 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 3. Absence of acute medical illness, significant physical exam findings, or laboratory abnormalities, as determined by the investigator. 4. 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. 5. Body mass index (BMI) =18.5 and =65 years) yes F.1.3.1 Number of subjects for this age range 1000
Exclusion criteria
Exclusion criteria: 1. History of COVID-19 infection within the last 3 months before screening. 2. Previous vaccination with a SARS-CoV-2 vaccine other than those mentioned in inclusion criterion #2. 3. Positive test for SARS-CoV-2 infection at screening. 4. Breastfeeding with intent to continue. 5. 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. 6. History of myocarditis or pericarditis. 7. 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. 8. Known or suspected impairment of immunologic functions including, but not limited to, known immunodeficiency syndrome. 9. 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. 10. 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, or electrocardiogram (ECG) outside normal range at screening and deemed clinically relevant by the investigator. 11. Clinically significant mental disorder not adequately controlled by medical treatment. 12. Active or recent history (within 6 months before screening) of chronic alcohol abuse, or illicit drug abuse. 13. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 14. History of anaphylaxis or severe allergic reaction to any vaccine. 15. History of any vaccinations or plan to receive any vaccinations with a live vaccine within 30 days prior to or after trial vaccination. 16. History of any vaccinations or plan to receive any vaccinations with a non-live vaccine within 14 days prior to or after trial vaccination. 17. 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. 18. 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. 19. History of organ transplantation, whether or not accompanied by chronic immunosuppressive therapy. 20. 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). 21. 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. 22. Involvement in this trial as site personnel. 23. Known bleeding disorder that, in the opinion of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this phase 3 trial is to assess the non-inferiority, or superiority of vaccination with ABNCoV2 compared to Comirnaty in terms of neutralizing antibodies against the SARS CoV 2 index virus (Wuhan wild type isolate). This objective will be carried out in the randomized, double-blind component (Part A), in Cohort 1 (adult subjects who previously completed primary vaccination only) and Cohort 2 (adult subjects who have received 1 booster vaccination after a primary regimen) simultaneously. If the non-inferiority margin is met, superiority comparison will be carried out in the same cohort with the same type I error level. If for any reason, the minimum sample size of 400 is not met in one cohort, data from that cohort will be summarized descriptively. ;Secondary Objective: The key secondary objective is to assess the non-inferiority, or superiority of vaccination with ABNCoV2 compared to Comirnaty in terms of neutralizing antibodies against VOCs circulating at the time of the trial, again in Part A Cohort 1 and Cohort 2. Variants of concern might include Omicron (B.1.1.529), Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), and/or Delta (B.1.617.2). If the non-inferiority margin is met for a VOC, superiority comparison will be carried out in the same cohort with the same type I error level. Another secondary objective is to assess the neutralizing antibody titers against the SARS-CoV-2 index virus in the immunogenicity subsets of the single-arm component (Part B), for Cohort 1 and Cohort 2. ;Primary end point(s): Part A: Geometric mean titer (GMT) of neutralizing antibodies against the SARS-CoV-2 index virus at 2 weeks after trial vaccination, in each Part A cohort. ;Timepoint(s) of evaluation of this end point: Ratio of GMTs at 2 weeks after trial vaccination, for ABNCoV2 vaccine compared to Comirnaty vaccine, is within the non-inferiority margin of 0.67; specifically, the success criterion will be met within each cohort if the lowe | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): If both Cohort 1 and Cohort 2 are tested for and meet the success criterion for the primary endpoint, VOCs will be tested in the cohort with the higher number of evaluable subjects, followed by the cohort with the smaller number of evaluable subjects if the success criterion is met in at least one of the tested VOCs in the cohort tested first. In the event only one cohort meets the success criterion for the primary endpoint, VOCs will be formally tested for the successful cohort only. ;Timepoint(s) of evaluation of this end point: Ratios of GMTs for the VOCs at 2 weeks after trial vaccination, for ABNCoV2 vaccine compared to Comirnaty vaccine, will be tested using the non-inferiority margin of 0.67 as was used for the primary endpoint. The result will be based on the lower limit of a two-sided CI with coverage determined based on the number of VOCs circulating at the time of the trial. A Bonferroni correction will be employed for the simultaneous non-inferiority tests to control the trial-wide type I error. | — |
Countries
Belgium, Denmark, United States
Contacts
Public Contactclinical-mailbox
Bavarian Nordic GmbH
Outcome results
None listed