At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1a/1b, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the COVID-19 (SARS-CoV-2) Vaccine Candidates VBI-2902a and VBI-2905a in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating VBI-2902a, Placebo, and 1 other intervention for Covid19. Completed, enrolled 114 participants across 4 sites.
Detailed Summary
VBI-2902a and VBI-2905a are investigational vaccine candidates that use enveloped virus-like particle (eVLP) expression of a modified version of the SARS-CoV-2 spike (S) glycoprotein and are designed to induce neutralizing antibody and cell-mediated immune responses against the SARS-CoV-2 spike protein. VBI-2902a expresses the spike protein of SARS-CoV-2 Wuhan isolate (the first virus variant isolated in 2019 in Wuhan, China), while VBI-2905a expresses the spike protein of SARS-CoV-2 variant Beta (B.1.351 variant, first isolated in 2020 in South Africa). The Phase 1a portion of this study tests one- and two-dose regimens of VBI- 2902a with 5 μg S protein content and aluminum phosphate (alum) adjuvant or placebo delivered by intramuscular (IM) injection. The Phase 1b portion of the study tests a one-dose regimen of VBI-2905a with 5 μg S protein content and alum adjuvant or placebo delivered by IM injection in participants previously vaccinated with an authorized mRNA COVID-19 vaccine.
Study Details
Timeline
Interventions
VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
0.9% sodium chloride
VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.