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COMPLETED
NCT05548439
PHASE1

Safety, Tolerability, and Immunogenicity of Trivalent Coronavirus Vaccine Candidate VBI-2901a

Sponsor: VBI Vaccines Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 1, Randomized Study to Evaluate the Safety and Immunogenicity of VBI-2901a, a Trivalent Coronavirus Vaccine Candidate in Healthy Adults Previously Vaccinated With Licensed COVID-19 Vaccines

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2022-10-05

Completion Date

2024-01-16

Last Updated

2026-05-11

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

VBI-2901a

Intramuscular injection of VBI-2901a, an investigational trivalent coronavirus vaccine that contains three coronavirus spike proteins with aluminum phosphate adjuvant.

Locations (7)

Canadian Center for Vaccinology

Halifax, Nova Scotia, Canada

Red Maple Trials

Ottawa, Ontario, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

LMC Manna - Bayview CPU

Toronto, Ontario, Canada

LMC Manna Toronto

Toronto, Ontario, Canada

Manna Research Inc

Pointe-Claire, Quebec, Canada

CHU de Québec Université Laval

Québec, Quebec, Canada