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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
197
IM injection 100ug dose
IM injection 50ug dose
Emovis GmbH
Berlin, Germany
Velocity Clinical Research Hamburg
Hamburg, Germany
Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV)-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination
The primary endpoint was SARS-CoV-2 index virus neutralizing antibody titers by pseudovirus assay at 2 weeks after the last vaccination, i.e., after the second vaccination in initially seronegative subjects (Group 1) and after the single boost vaccination in initially seropositive subjects (Groups 2 and 3), for subjects in the Immunogenicity Analysis Set.
Time frame: 2 weeks after the second vaccination in initially seronegative subjects (Group 1) and after the single boost vaccination in initially seropositive subjects (Groups 2 and 3)
Subjects Reporting Any SAEs or AESIs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination
Subjects reporting any serious adverse events (SAEs) or adverse events of special interest (AESIs) assessed as related to trial vaccine within 8 days after vaccination
Time frame: Within 8 days of the Day 1 vaccination for Groups 1, 2, and 3, as well as within 8 days of the Day 29 vaccination for Group 1.
Subjects Reporting Any Grade ≥ 3 AEs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination
Subjects reporting any Grade ≥ 3 adverse events (AEs) assessed as related to trial vaccine within 8 days after vaccination
Time frame: Within 8 days of the Day 1 vaccination for Groups 1, 2, and 3, as well as within 8 days of the Day 29 vaccination for Group 1.
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