WithdrawnPhase 1

Safety, Tolerability, and Immunogenicity of Trivalent Coronavirus Vaccine Candidate VBI-2901e With E6020 Adjuvant

Stopped: Study was halted prematurely prior to enrollment of first participant based on study sponsor's decision to prioritize clinical development of VBI-2901a.

Canada0Started 2023-03

Plain-language summary

VBI-2901e 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 coronavirus, variants and subvariants of SARS-CoV-2 (such as Beta, Delta and Omicron BA.5) and other related coronaviruses that could emerge in the future. VBI-2901e contains two adjuvants: aluminum phosphate and E6020. The role of the adjuvants is to create a stronger immune response to the vaccine. This Phase 1 study will be an open-label study of VBI-2901e comparing three dose levels of the E6020 adjuvant component (1, 3, or 10 µg per dose) in adults 18 to 40 years of age who had previously received two or more vaccinations with licensed COVID-19 vaccine(s). VBI-2901e at each dose level of E6020 will be administered as either a single dose or two-dose regimen. The purpose of the study is to test the safety of VBI-2901e and to learn more about its ability to boost immune responses against SARS-CoV-2 and the two related coronaviruses SARS-CoV-1 and MERS-CoV.

Who can participate

Age range18 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female subject 18-40 years of age
✓. Be 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
✓. Healthy participants with no chronic medical conditions at study enrollment and during the 6 months before enrollment. Participants with history of asymptomatic SARS-CoV-2 infection who tested positive by PCR or rapid antigen test or participants with history of having signs and symptoms mild COVID-19 illness (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who did not have shortness of breath, dyspnea, or abnormal chest imaging are eligible for the study if they fully recovered a minimum of 6 months before enrollment.
✓. Meets reproductive inclusion criteria
✓. Have previously received 2 or more doses of a licensed COVID-19 vaccine(s) with the last dose administered a minimum of 6 months (24 weeks) prior to enrollment. Participants vaccinated with any of the vaccines approved by Health Canada for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 18 years of age and older are eligible for the study. This includes the following COVID-19 vaccines: Moderna Spikevax®, Pfizer-BioNTech Comirnaty®, AstraZeneca Vaxzevria®, Janssen Jcovden® (Johnson \& Johnson), Novavax Nuvaxovid® and Medicago Covifenz®. Participants who received one or more doses of VBI-2902a, VBI-2905a or any other COVID-19 vaccines that are either investigational or not approved by Health Canada are not eligible for the study.

What they're measuring

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 56

Trial details

NCT IDNCT05614245

SponsorVBI Vaccines Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06

View on ClinicalTrials.gov More COVID-19 trials

Plain-language summary

Who can participate

Age range18 Years – 40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female subject 18-40 years of age
✓. Be 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
✓. Healthy participants with no chronic medical conditions at study enrollment and during the 6 months before enrollment. Participants with history of asymptomatic SARS-CoV-2 infection who tested positive by PCR or rapid antigen test or participants with history of having signs and symptoms mild COVID-19 illness (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who did not have shortness of breath, dyspnea, or abnormal chest imaging are eligible for the study if they fully recovered a minimum of 6 months before enrollment.
✓. Meets reproductive inclusion criteria
✓. Have previously received 2 or more doses of a licensed COVID-19 vaccine(s) with the last dose administered a minimum of 6 months (24 weeks) prior to enrollment. Participants vaccinated with any of the vaccines approved by Health Canada for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) in individuals 18 years of age and older are eligible for the study. This includes the following COVID-19 vaccines: Moderna Spikevax®, Pfizer-BioNTech Comirnaty®, AstraZeneca Vaxzevria®, Janssen Jcovden® (Johnson \& Johnson), Novavax Nuvaxovid® and Medicago Covifenz®. Participants who received one or more doses of VBI-2902a, VBI-2905a or any other COVID-19 vaccines that are either investigational or not approved by Health Canada are not eligible for the study.

What they're measuring

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 56

Safety, Tolerability, and Immunogenicity of Trivalent Coronavirus Vaccine Candidate VBI-2901e With E6020 Adjuvant

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Safety, Tolerability, and Immunogenicity of Trivalent Coronavirus Vaccine Candidate VBI-2901e With E6020 Adjuvant

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Exclusion criteria