CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 197 enrolled
Drug / intervention
ABNCoV2 100ug +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05077267
NCT05077267Phase 2Completed

An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of the ABNCoV2 Vaccine in Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV)-2 Seronegative and Seropositive Adult Subjects

Bavarian Nordic·interventional·Posted Oct 14, 2021·Updated Sep 27, 2024

In Brief

A Phase 2 clinical trial evaluating ABNCoV2 100ug and ABNCoV2 50ug for COVID-19 Disease. Completed, enrolled 197 participants across 2 sites.

Detailed Summary

An open label phase 2 trial to evaluate safety, tolerability and immunogenicity of the ABNCoV2 vaccine after intramuscular (IM) application. The trial will evaluate a homologous prime-boost regimen with 100 µg ABNCoV2 in initially seronegative adult subjects (Group 1), as determined by a qualitative test for SARS-CoV-2 antibodies, compared to a single boost vaccination with 100 µg (Group 2) or 50 µg (Group 3) ABNCoV2 in initially seropositive subjects, as defined by a positive qualitative test for SARS-CoV-2 antibodies and a history of SARS-CoV-2 vaccination or previous COVID-19 disease at least 90 days prior to planned trial vaccination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedOct 14, 2021
Enrollment StartAug 19, 2021
Primary CompletionFeb 2, 2022
Study CompletionOct 31, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.7 years ago

Interventions

ABNCoV2 100ugbiological

IM injection 100ug dose

ABNCoV2 50ugbiological

IM injection 50ug dose