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

NCT05548439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

VBI-2901a

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

Sponsors & Collaborators

  • VBI Vaccines Inc.

    lead INDUSTRY

Principal Investigators

  • William Cameron, MD · Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-05
Primary Completion
2024-01-16
Completion
2024-01-16

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05548439 on ClinicalTrials.gov