VBI-2901a for COVID19 (disease)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
LMC Manna - Bayview CPU, Toronto, Canada
COVID19 (disease)+3 More
VBI-2901a - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • COVID19 (disease)
  • COVID-19
  • Coronavirus Infections

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 7 Secondary · Reporting Duration: Through end of study (approximately 1 year)

Day 1
Serum binding IgG subclasses
Day 1
Seroresponse rate against SARS-CoV-1 and MERS-CoV
Seroresponse rate against SARS-CoV-2 ancestral (Wuhan) strain
Seroresponse rate against SARS-CoV-2 variants of concern (Beta, Delta and Omicron)
Day 1
GMT of neutralizing antibodies against potentially zoonotic beta-coronaviruses
Geometric mean fold rise (GMFR) in serum neutralizing antibody titer against SARS-CoV-2 ancestral (Wuhan) strain and variants of concern (Beta, Delta and Omicron), SARS-CoV-1 and MERS-CoV
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibodies
Day 1
GMT and GMFR in serum IgG antibody to spike protein and receptor-binding-domain (RBD) against SARS-CoV-2 ancestral (Wuhan) strain, selected SARS-CoV-2 variants (Beta, Delta and Omicron), SARS-CoV-1 and MERS-CoV
Day 1
Interferon-gamma-positive cells against spike protein from SARS-CoV-2 ancestral (Wuhan) strain, selected SARS-CoV-2 variants (Beta, Delta and Omicron), SARS-CoV-1 and MERS-CoV
Day 28
Unsolicited adverse events within 28 days of study vaccination
Day 7
Local reactions (solicited adverse events) within 7 days of study vaccination
Systemic reactions (solicited adverse events) within 7 days of study vaccination
Year 1
Medically-attended adverse events within 28 days of study vaccination and end of study
Serious adverse events within 28 days of study vaccination and end of study

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Group G3
1 of 3
Group G1
1 of 3
Group G2
1 of 3
Experimental Treatment

99 Total Participants · 3 Treatment Groups

Primary Treatment: VBI-2901a · No Placebo Group · Phase 1

Group G3
Biological
Experimental Group · 1 Intervention: VBI-2901a · Intervention Types: Biological
Group G1
Biological
Experimental Group · 1 Intervention: VBI-2901a · Intervention Types: Biological
Group G2
Biological
Experimental Group · 1 Intervention: VBI-2901a · Intervention Types: Biological

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through end of study (approximately 1 year)
Closest Location: LMC Manna - Bayview CPU · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
N/AFirst Recorded Clinical Trial
0 TrialsResearching COVID19 (disease)
0 CompletedClinical Trials

Who is running the clinical trial?

VBI Vaccines Inc.Lead Sponsor
9 Previous Clinical Trials
5,513 Total Patients Enrolled
William Cameron, MDPrincipal InvestigatorOttawa Hospital
2 Previous Clinical Trials
226 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a male or female subject aged 18 to 64 years.
You are willing and able to provide personally signed informed consent indicating understanding of the purpose, procedures required for the study and potential risks and benefits of the study, and be willing to participate in the study.
You are of childbearing potential and must have a negative pregnancy test prior to study vaccinations and agree to use an effective method of birth control as deemed appropriate by the investigator (e.g.
Be abstinent from heterosexual intercourse with a female of childbearing potential OR Must agree to use a male condom

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.