VBI vaccines starts clinical trials for multivalent coronavirus vaccine candidate
Coronaviruses are enveloped viruses by nature, making them prime targets for the company’s flexible eVLP technology, says the company. A Phase 1a/1b study of two monovalent, variant-specific vaccine candidates has already generated human proof-of-concept data, demonstrating safety, tolerability and immunogenicity of the platform.
Now, the multivalent version is targeting BA.4 and BA.5 as well as the ancestral strain, Delta, Beta, Lambda, Omicron, and wider pangolin and bat coronaviruses distantly related to circulating human strains.
Pre-clinical studies have suggested the multivalent version already elicited a stronger response than variant-specific candidates.
Three in one
VBI-2900 consists of three enveloped virus-like particle (eVLP) vaccine candidates. The first, VBI-2901, is a multivalent coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins. The second is VBI-2902, a monovalent COVID-19 vaccine expressing a modified prefusion form of the SARS-CoV-2 ancestral spike protein, and finally VBI-2905 is a monovalent COVID-19 vaccine expressing a modified prefusion form of the spike protein from the Beta variant (also known as B.1.351).
Jeff Baxter, VBI’s President and CEO, said: “We strive to contribute to the long-term solution in the fight against coronaviruses and remain committed to supporting our public health partners. As we work to develop a vaccine capable of providing broad protection against known, emerging, and as-yet-unknown COVID-19 and coronavirus strains, we believe this study initiation is a meaningful step toward that goal.”
The Phase 1 randomized, open-label study will enroll three cohorts of subjects, randomized 1:1:1, to compare either two intramuscular doses of VBI-2901 at a low- (5µg) or high- (10µg) dose level, or one dose of VBI-2901 at the high-dose level (10µg) in approximately 100 healthy adults aged 18-64 who have previously received at least a primary series of immunizations from a licensed vaccine (Health Canada's licensed vaccines) with the last dose at least two months before.
This study is supported by funding from the Government of Canada’s Innovation, Science and Economic Development (ISED) through the Strategic Innovation Fund.