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Virus Vaccine

Group G1, Subgroup G1-B for COVID-19

Phase 1
Waitlist Available
Led By William Cameron, MD
Research Sponsored by VBI Vaccines Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets reproductive inclusion criteria
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through end of study (approximately 1 year)
Awards & highlights

Study Summary

This trial will test if VBI-2901e vaccine is safe and boosts immunity against COVID-19 and other related coronaviruses. It includes 3 dose levels of the vaccine, a single dose or 2-dose regimen.

Eligible Conditions
  • COVID-19
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are able to have children and meet the requirements for participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through end of study (approximately 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of study (approximately 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vaccination
Vaccination
Vaccination
+3 more
Secondary outcome measures
Immunoglobulin G
Immunoglobulin G
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
+5 more
Other outcome measures
Zoonoses

Trial Design

6Treatment groups
Experimental Treatment
Group I: Group G3, Subgroup G3-BExperimental Treatment1 Intervention
10 participants aged 18-40 years to receive two doses of VBI-901e at 5 µg spike protein and 10 µg E6020 per dose at Day 1 and Day 28
Group II: Group G3, Subgroup G3-AExperimental Treatment1 Intervention
10 participants aged 18-40 years to receive one dose of VBI-2901e at 5 µg spike protein and 10 µg E6020 per dose at Day 1
Group III: Group G2, Subgroup G2-BExperimental Treatment1 Intervention
10 participants aged 18-40 years to receive two doses of VBI-901e at 5 µg spike protein and 3 µg E6020 per dose at Day 1 and Day 28
Group IV: Group G2, Subgroup G2-AExperimental Treatment1 Intervention
10 participants aged 18-40 years to receive one dose of VBI-2901e at 5 µg spike protein and 3 µg E6020 per dose at Day 1
Group V: Group G1, Subgroup G1-BExperimental Treatment1 Intervention
10 participants aged 18-40 years to receive two doses of VBI-901e at 5 µg spike protein and 1 µg E6020 per dose at Day 1 and Day 28
Group VI: Group G1, Subgroup G1-AExperimental Treatment1 Intervention
10 participants aged 18-40 years to receive one dose of VBI-2901e at 5 µg spike protein and 1 µg E6020 per dose at Day 1

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

VBI Vaccines Inc.Lead Sponsor
11 Previous Clinical Trials
5,692 Total Patients Enrolled
2 Trials studying COVID-19
217 Patients Enrolled for COVID-19
William Cameron, MDPrincipal InvestigatorOttawa Hospital
3 Previous Clinical Trials
329 Total Patients Enrolled
2 Trials studying COVID-19
217 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What key aims are researchers targeting with this experiment?

"The primary aim of this trial, assessable over a 28-day period after each vaccination, is to record any medically attended adverse events. Secondary endpoints include measuring the geometric mean titer (GMT) and fold rise (GMFR) in titers against SARS-CoV-2 ancestral strain, variants Beta Delta and Omicron as well as both SARS-CoV1 and MERS CoV at Days 1 7 28 35 56 84 168 336. The GMFR of serum IgG antibodies to Spike Protein and Receptor Binding Domain will also be evaluated using ELISA tests across the same time frame."

Answered by AI

Are there any limitations on who can join this investigation?

"This research study is recruiting 60 people aged 18-40 who have been infected with coronavirus. The most pertinent criteria for participants includes: gender, good physical health without chronic medical conditions in the past 6 months, reproductive status (eg. postmenopausal or surgically sterile), agreement to use effective birth control and condoms during the trial period, no prior donation of sperm and previously received 2+ doses of a Health Canada approved COVID-19 vaccine administered 24 weeks before enrollment."

Answered by AI

Are there any open opportunities to join this experiment?

"The details on clinicaltrials.gov reveal that this investigation is not presently seeking subjects. The trial was first posted November 1st 2022 and last edited November 10th 2022, though there are still 1050 other trials open to registration at the time of writing."

Answered by AI

What risks accompany the administration of Group G3, Subgroup G3-A to patients?

"Given the limited data available in regards to efficacy and safety, our team at Power assigned Group G3, Subgroup G3-A a score of 1 on their scale."

Answered by AI

Is eligibility for this trial contingent upon a specific age threshold?

"This medical trial only permits patients between 18 and 40 years old to be enrolled, as stated in the eligibility criteria."

Answered by AI
~0 spots leftby Jun 2024