Phase 2 N=197 Treatment

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

COVID-19 Disease

Bottom Line

View on ClinicalTrials.gov: NCT05077267 ↗

Enrolled (actual)

197

Serious AEs

3.1%

Results posted

Sep 2024

Primary outcome: Primary: Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV)-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination — 516.7; 970.9; 978.9 titer

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: ABNCoV2 100ug (Biological); ABNCoV2 50ug (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bavarian Nordic
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Severe Acute Respiratory Syndrome (SARS) Coronavirus (CoV)-2 Index Virus Neutralizing Antibody Titers at 2 Weeks After the Last Vaccination	516.7; 970.9; 978.9	—
SECONDARY Subjects Reporting Any SAEs or AESIs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination	0; 0; 0	—
SECONDARY Subjects Reporting Any Grade ≥ 3 AEs Assessed as Related to Trial Vaccine Within 8 Days After Vaccination	0; 0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Seronegative (Group 1): negative qualitative test for SARS-CoV-2 antibodies at SCR.

Seropositive (Group 2 and Group 3): Previous COVID-19 disease or previously completed vaccination regimen with an authorized SARS-CoV-2 vaccine at least 90 days before planned trial vaccination and a positive qualitative test for SARS-CoV-2 antibodies at SCR. "Authorized" SARS-CoV-2 vaccine refers to authorization status at SCR, i.e., subjects can be eligible if the subject previously received investigational vaccines that have since been authorized for emergency use or granted full market licensure. Receipt of a single dose of an authorized COVID-19 vaccine regimen in subjects with a previous diagnosis of COVID-19 or a mix/match series of 2 doses of any authorized COVID-19 vaccine will be considered as a completed vaccination.

General good health, without acute medical illness, physical exam findings, or laboratory abnormalities, as determined by the investigator.
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 the last vaccination. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is allowed.
Post organ transplant subjects, whether or not receiving 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 the last 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05077267). 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.