NCT05329220

ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,205 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19 Disease

Interventions

Type	Name	Description
BIOLOGICAL	ABNCoV2	ABNCoV2 100μg single dose
BIOLOGICAL	Comirnaty	Comirnaty

Timeline

• Start date: 2022-08-30
• Primary completion: 2023-03-15
• Completion: 2023-10-05
• First posted: 2022-04-14
• Last updated: 2025-02-24
• Results posted: 2025-02-24

Locations

57 sites across 3 countries: United States, Belgium, Denmark

Regulatory

• FDA-regulated drug study