VBI-2901a is an investigational vaccine candidate that uses enveloped virus-like particles (eVLPs) to express the spike proteins of three coronaviruses: SARS-CoV-2 (the virus that causes COVID-19 disease), SARS-CoV-1 and MERS-CoV. The trivalent vaccine candidate is designed to induce neutralizing antibody and cell-mediated immune responses against the spike protein of the original strain of SARS-CoV-2, SARS-CoV-2 variants (such as Beta, Delta and Omicron) and other related coronaviruses that could emerge in the future. The Phase 1 study will be an open-label comparison of two intramuscular doses of VBI-2901a at 5 µg or 10 µg per dose or one dose of VBI-2901a at 10 µg per dose in adults 18 to 64 years of age who had previously received two or more vaccinations with licensed COVID-19 vaccines. The purpose of the study is to test the safety of VBI-2901a and to know more about its ability to boost immune response against SARS-CoV-2 (the virus that causes COVID-19 disease) and two other related coronaviruses SARS-CoV-1 and MERS-CoV.
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Local reactions (solicited adverse events) within 7 days of study vaccination
Timeframe: Through 7 days after each vaccination
Systemic reactions (solicited adverse events) within 7 days of study vaccination
Timeframe: Through 7 days after each vaccination
Unsolicited adverse events within 28 days of study vaccination
Timeframe: Through 28 days after each vaccination
Serious adverse events within 28 days of study vaccination and end of study
Timeframe: Through end of study (approximately 1 year)
Medically-attended adverse events within 28 days of study vaccination and end of study
Timeframe: Through end of study (approximately 1 year)
Seroresponse rate against SARS-CoV-2 ancestral (Wuhan) strain
Timeframe: Study days 1, 28 and 84