NCT05077267

ABNCoV2 Vaccine in SARS-CoV-2 (COVID-19) Seronegative and Seropositive Adult Subjects

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

For this Phase 2 trial ABNCoV2-01, in a run in phase 6 adults (comprising of 3 subjects in each Group 1 and 2) will be vaccinated at 1 clinical trial site in a consecutive manner, with an at least 48 hours interval between the first and second subject of each group, then the second and third subject dosed on consecutive days, before opening up to full enrolment of the trial. Safety assessments will be based on solicited and unsolicited adverse event (AE) data (first week after vaccination) evaluated by an independent Data Monitoring Committee (DMC). After a positive DMC recommendation, enrolment to the rest of Group 1 and 2 of the trial will commence. Group 3 subjects will be enrolled after completion of Group 2 enrollment. This phase 2 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) and 50 µg (Group 3) ABNCoV2 in initially seropositive subjects, as defined by a positive qualitative test for SARS-CoV-2 antibodies and either a history of SARS-CoV-2 vaccination or previous COVID-19 disease (Group 2 and 3) at least 90 days prior to planned trial vaccination. Due to the timing of the addition of Group 3, enrollment into Group 2 will be completed prior to enrolling subjects into Group 3. Therefore, no randomization will be required for the seropositive subjects.

Conditions

• COVID-19 Disease

Interventions

Type	Name	Description
BIOLOGICAL	ABNCoV2 100ug	IM injection 100ug dose
BIOLOGICAL	ABNCoV2 50ug	IM injection 50ug dose

Timeline

• Start date: 2021-08-19
• Primary completion: 2022-02-02
• Completion: 2023-10-31
• First posted: 2021-10-14
• Last updated: 2024-09-27
• Results posted: 2024-09-27

Locations

2 sites across 1 country: Germany