VIDO has developed a vaccine called COVAC-1. The COVAC-1 study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. COVAC-1 contains a TriAdj adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The vaccine is expected to stimulate the body to make antibodies against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent COVID-19 illness. In animal studies, the immune response generated by the COVAC-1 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection. The COVAC-005 Study is a Phase I, multi-centre trial of a SARS-CoV-2 vaccine booster. This is a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of COVAC-1 booster dose administered once in generally healthy adults 18-65 years of age who have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to Day 0. The study will follow a dose-escalation design to test the safety and immunogenicity of three dosage levels (10, 25 and 50 µg). In each dose escalation group participants will be randomized in a 3:1 ratio, to receive either the investigational product or a placebo, respectively. Stratification will be according to the Investigational product dose received. Sub-analysis will be completed in two age groups, 18-54 and 55-65 years. Study participants will be initially randomized to the lowest dose of 10 µg or placebo. After approval by the Sponsor and based on the recommendations from the DSMB following the Day 7 safety analysis, new study participants will be allowed to be randomized in the higher dose escalation group of 25 µg. Approval will also be sought from the Sponsor, based upon the DSMB recommendation, to proceed with the higher dose of 50 µg. Within each dose escalation group of 16 participants (12 active vaccine recipients, and 4 placebo recipients) it is proposed to randomize a first cohort of 4 participants, including at least 3 active vaccine recipients, and pending no holding rule is met after 48 hours, as determined by the post-injection phone call, the remaining 12 participants within that dose escalation group will be randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
47
Intramuscular vaccine against SARS-CoV-2
Intramuscular injection of saline placebo
Diex Recherche Joliette Inc.
Joliette, Quebec, Canada
Diex Recherche Quebec Inc.
Québec, Quebec, Canada
Diex Recherche Sherbrooke
Sherbrooke, Quebec, Canada
DIEX Recherche Victoriaville
Victoriaville, Quebec, Canada
Assessment of the safety of COVAC-1 booster vaccine (10, 25 and 50 μg dosing of S1 antigen) in generally healthy volunteers
Incidence of solicited adverse events (AE) up to 7 days post-injection; unsolicited AEs up to 28 days post-injection; any clinically significant laboratory finding up to 28 days post-injection; and any serious AEs (SAEs), potential immune medicated disease (pIMDs), medically attended events or COVID-19 illness up to 365 days.
Time frame: Up to 365 days
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by spike protein-specific Enzyme Linked Immunosorbent Assay (ELISA)
Study samples will be tested to assess the level of anti-SARS-CoV-2 spike IgG binding antibodies present in the human serum samples by using a validated ELISA.
Time frame: Up to Day 365.
To assess the immune response induced by COVAC-1 booster vaccine, as measured by cell immune response markers using flow cytometry.
Peripheral Blood Mononuclear Cells (PBMCs) samples collected pre- and post-injection will be assessed for spike protein-specific Helper T-lymphocytes (CD4+) and Cytotoxic T-lymphocytes (CD8+) population producing cytokine profile.
Time frame: Up to Day 365.
To assess the immune response induced by COVAC-1 booster vaccine, as measured by cell immune response markers using an ELISpot assay.
Peripheral Blood Mononuclear Cells (PBMCs) samples collected pre- and post-injection will be assessed for spike peptide-specific T cell responses, IFN-gamma and IL-5, as a measurement of COVAC-1 immune response induction.
Time frame: Up to Day 365.
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by virus microneutralization assay.
Study samples will be tested to assess the level of SARS-CoV-2 Wuhan neutralizing antibodies present in the human serum samples by SARS-CoV-2 live virus microneutralization assay.
Time frame: Up to Day 365.
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by pseudovirus neutralization assay.
Study samples will be tested to assess the level of SARS-CoV-2 Wuhan pseudovirus neutralizing antibodies present in the human serum samples by SARS-CoV-2 pseudotyped virus neutralization assay.
Time frame: Up to Day 365.
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