Phase 3
N=4,205
ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2
COVID-19 Disease
Bottom Line
View on ClinicalTrials.gov: NCT05329220 ↗Enrolled (actual)
4,205
Serious AEs
2.0%
Results posted
Feb 2025
Primary outcome: Primary: Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination — 1018.1; 1060.6; 1259.0; 1619.6 titer — p=0.6350
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABNCoV2 (Biological); Comirnaty (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bavarian Nordic
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neutralizing Antibody Titers Against the SARS-CoV-2 Index Virus (Wuhan Wild Type Isolate) at 2 Weeks After Trial Vaccination |
1018.1; 1060.6; 1259.0; 1619.6 | 0.6350 |
| 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 |
17112.6; 23506.3; 54.7; 81.3 | 0.0008 sig |
| 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] |
— | — |
| 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. |
0; 0; 0; 0; 0; 0 | — |
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.
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 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.
Data sourced from ClinicalTrials.gov (NCT05329220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.