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

NCT05548439 | Unknown Phase 1 DMC

• 1 other identifier: VBI-2901a-CT01
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 7

Brief 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

COVID-19; Coronavirus Infections

Keywords

COVID-19; SARS-CoV-2; SARS-CoV-1; MERS-CoV; vaccine; enveloped virus-like particle (eVLP); coronavirus

Outcome Measures

Primary Outcomes (6)

• Local reactions (solicited adverse events) within 7 days of study vaccination

  Through 7 days after each vaccination

• Systemic reactions (solicited adverse events) within 7 days of study vaccination

  Through 7 days after each vaccination

• Unsolicited adverse events within 28 days of study vaccination

  Through 28 days after each vaccination

• Serious adverse events within 28 days of study vaccination and end of study

  Through end of study (approximately 1 year)

• Medically-attended adverse events within 28 days of study vaccination and end of study

  Through end of study (approximately 1 year)

• Seroresponse rate against SARS-CoV-2 ancestral (Wuhan) strain

  Percent of participants with ≥ 4-fold rise in neutralizing antibody titer at 28 days after the first vaccination and, in participants receiving two doses, 28 days after the second vaccination, compared to baseline (Day 1).

  Study days 1, 28 and 84

Secondary Outcomes (7)

• Seroresponse rate against SARS-CoV-2 variants of concern (Beta, Delta and Omicron)

  Study days 1, 28 and 84

• Seroresponse rate against SARS-CoV-1 and MERS-CoV

  Study days 1, 28 and 84

• Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibodies

  Study days 1, 7, 28, 56, 63, 84, 168 and 336

• 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

  Study days 1, 7, 28, 56, 63, 84, 168 and 336

• 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

  Study days 1, 7, 28, 56, 63, 84, 168, and 336

Other Outcomes (1)

• GMT of neutralizing antibodies against potentially zoonotic beta-coronaviruses

  Study days 1, 7, 28, 56, 63, 84, 168 and 336

Study Arms (3)

Group G1

EXPERIMENTAL

33 participants aged 18-64 years to receive two doses of VBI-2901a at 5 µg per dose at Day 1 and Day 56.

Biological: VBI-2901a

Group G2

EXPERIMENTAL

33 participants aged 18-64 years to receive two doses of VBI-2901a at 10 µg per dose at Day 1 and Day 56.

Biological: VBI-2901a

Group G3

EXPERIMENTAL

33 participants aged 18-64 years to receive one dose of VBI-2901a at 10 µg per dose at Day 1.

Biological: VBI-2901a

Interventions

VBI-2901a BIOLOGICAL

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

Group G1; Group G2; Group G3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subject 18-64 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
• Be healthy or in stable health. Participants with pre-existing, stable, well-controlled disease, defined as mild disease or medical condition not requiring medical therapy or not requiring a change in medical therapy due to worsening of disease during the 6 months before enrollment may be enrolled at the discretion of the investigator. 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.
• Female participants
• Female participant is eligible if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
• is 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., hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) beginning \>30 days prior to the first study vaccine administration and continuing for a minimum of 30 days after the last dose of study vaccine.
• is not of childbearing potential, defined as postmenopausal (a minimum of 12 months with no menses without an alternative medical cause) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
• Male participants
• Male participant is eligible to participate if he agrees to the following requirements from the time of first study vaccination until at least 30 days after the last dose of study vaccine:
• Be abstinent from heterosexual intercourse with a female of childbearing potential OR
• Must agree to use a male condom. In addition to male condom use, an effective method of contraception may be considered in female partners of male participants AND
• Must refrain from sperm donation
• 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.

You may not qualify if:

• History of COVID-19 illness of moderate or greater severity, defined as one of the following:
• Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have an oxygen saturation (SpO2) ≥94% on room air at sea level.
• Severe COVID-19 illness: Individuals who have SpO2 \<94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) \<300 mm Hg, a respiratory rate \>30 breaths/min, or lung infiltrates \>50%.
• Critical COVID-19 illness: Individuals who have respiratory failure, septic shock, and/or multiple organ dysfunction.
• Participants with a known history of SARS-CoV-1 or MERS infection.
• Positive SARS-CoV-2 PCR or rapid antigen test at screening.
• Participant with a history of an underlying clinically significant acute or chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation in the study would not be in the best interest of the participant (e.g., could compromise participant's wellbeing) or that could prevent, limit, or confound the protocol-specified assessments.
• Individuals with medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• History of cancer requiring chemotherapy or radiation within 5 years
• Lack of participant's capacity (mental, social, behavioral), in the investigator's judgement, to provide informed consent for participation in the study.
• Known or suspected impairment of immunological function, including but not limited to autoimmune diseases:
• autoimmune diseases (e.g. multiple sclerosis, type 1 diabetes, myasthenia gravis, Crohn's disease and other inflammatory bowel diseases, celiac disease, systemic lupus erythematosus, scleroderma, including diffuse systemic form and CREST syndrome, systemic sclerosis, dermatomyositis polymyositis, rheumatoid arthritis, juvenile idiopathic arthritis, autoimmune thyroiditis - including Hashimoto thyroiditis, Grave's or Basedow's disease, immune thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune hepatitis, psoriasis, vitiligo, vasculitis, Guillain- Barré syndrome, transverse myelitis, Addison's disease, Bell's palsy and alopecia areata);
• secondary immunodeficiency disorders (e.g., Acquired Immunodeficiency Syndrome caused by Human Immunodeficiency Virus infection (HIV/AIDS), solid organ transplant, splenectomy);
• primary immunodeficiency disorders (e.g., common variable immune deficiency (CVID), defective phagocytic cell function and neutropenia syndromes, complement deficiency).
• History of allergic reactions or anaphylactic reaction to any vaccine component.

Sponsors & Collaborators

• VBI Vaccines Inc.: lead

Study Sites (7)

Canadian Center for Vaccinology

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Red Maple Trials

Ottawa, Ontario, K1H 1E4, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

LMC Manna - Bayview CPU

Toronto, Ontario, M4G 3E8, Canada

Location

LMC Manna Toronto

Toronto, Ontario, M9W 4L6, Canada

Location

Manna Research Inc

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

CHU de Québec Université Laval

Québec, Quebec, G1E 7G9, Canada

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome

Interventions

VBI-2900 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• William Cameron, MD

  Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: October 5, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

CA (7)