On Jun. 29, 2021, VBI Vaccines announced positive Phase 1 data from its Phase 1/2 trial of the first of its enveloped virus-like particle (eVLP) COVID-19 vaccine candidates, VBI-2902a, in healthy adults age 18-54 years of age. The 5ﾵg dose of VBI-2902a, which expresses an optimized SARS-CoV-2 spike antigen and is adjuvanted with aluminum phosphate, was generally well-tolerated and elicited potent immune responses significantly higher than those seen in human convalescent sera. The data established a robust human proof-of-concept, at a low dose without the use of a next-generation adjuvant, demonstrating the potency of the eVLP particulate delivery platform against COVID-19.

The ongoing adaptive Phase 1/2 clinical study is a randomized, observer-blind, placebo-controlled trial. The Phase 1 portion of the study assessed a 5µg dose of VBI-2902a, adjuvanted with aluminum phosphate, in both one- and two-dose vaccination regimens, with the second immunization given 28 days after the first. 61 healthy, previously unvaccinated adults, age 18-54, were enrolled in the Phase 1 portion of the study.

VBI-2900 consists of three enveloped virus-like particle (eVLP) vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, (2) VBI-2902, a monovalent COVID-19-specific vaccine expressing the native SARS-CoV-2 spike protein, and (3) VBI-2905, a monovalent COVID-19-specific vaccine expressing the spike protein from the Beta variant (also known as B.1.351). The vaccine program has been developed through collaborations with the National Research Council of Canada (NRC), the Coalition for Epidemic Preparedness Innovations (CEPI), and the Government of Canada, through their Strategic Innovation Fund.