A Clinical Trial to Study the COVAC-1 Booster Dose in Generally Healthy Adults

NCT05693272 | Completed Phase 1 DMC

• 1 other identifier: COVAC-005
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2 Infection

Keywords

COVID-19 Booster Vaccine

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 365 days

Secondary Outcomes (5)

• 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)

  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.

  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.

  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.

  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.

  Up to Day 365.

Other Outcomes (1)

• To assess the neutralizing antibody response induced by COVAC-1 against the Omicron and/or the most relevant currently circulating Variants of Concern.

  Up to 365 days

Study Arms (4)

COVAC-01 10µg group

EXPERIMENTAL

12 healthy adults ≥18 years of age receive the vaccine on Day 0.

Biological: COVAC-1

COVAC-01 25µg group

EXPERIMENTAL

12 healthy adults ≥18 years of age receive the vaccine on Day 0.

Biological: COVAC-1

COVAC-01 50µg group

EXPERIMENTAL

12 healthy adults ≥18 years of age receive the vaccine on Day 0.

Biological: COVAC-1

Placebo Control

PLACEBO COMPARATOR

12 healthy adults ≥18 years of age receive a dose of normal saline (placebo) on Day 0.

Biological: Saline Placebo

Interventions

COVAC-1 BIOLOGICAL

Intramuscular vaccine against SARS-CoV-2

COVAC-01 10µg group; COVAC-01 25µg group; COVAC-01 50µg group

Saline Placebo BIOLOGICAL

Intramuscular injection of saline placebo

Placebo Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female participants 18-65 years of age at the time of signing the informed consent form for the study.
• Good general health as confirmed by assessments completed no more than 30 days before study D0. Participants with mild to moderate well controlled comorbidities or having a medically stable condition, will be eligible. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization due to worsening during the 3 months prior to enrollment, and according to the judgment of the Investigator, hospitalization during the entire study period is not anticipated.
• Have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to the investigational booster dose injection. Proof of vaccination can be provided as a digital copy of the vaccination receipt on the participant's device, a screenshot of the receipt on the device, or a printed paper copy.
• Male participants, and heterosexually active females of child-bearing potential, must practice adequate contraception for 30 days prior to the injection and must agree to continue adequate contraception until 180 days after the injection. Negative pregnancy test will be obtained from female participants of child-bearing potential at screening and at Day 0.
• Provide a written informed consent for the study prior to performing any study-related procedure. The Investigator or a qualified designee must ensure the appropriate consent is in place.

You may not qualify if:

• Presence of any febrile illness or any known or suspected acute illness on the day of immunization.
• Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injection or venipuncture.
• Presence of an autoimmune disease.
• Receiving systemic steroids in doses exceeding 20mg daily of prednisone or equivalent, for ≥ 14 days within 1 month, or has recently received any other cytotoxic or immunosuppressive drug within 6 months prior to the injection of the study vaccine.
• Has a known malignancy diagnosed within the past 5 years. Participants with basal cell carcinoma or squamous cell carcinoma of the skin are not excluded.
• Currently receiving systemic immunomodulatory therapy or received chemotherapy within the last 5 years excluding topical agents.
• Has received blood products or immunoglobulins (IVIg or IMIg) within 3 months of study entry/baseline serologic evaluation.
• Currently on anti-tuberculosis therapy.
• Had SARS-CoV-2 infection within 4 months prior to study Day 0. A potential participant is considered to have COVID-19 infection base on one of the following:
• Positive polymerase chain reaction (PCR) or rapid antigen test.
• Documentation in a medical history report.
• Reported by candidate.
• Has received any non-COVID-19 authorized vaccines (e.g., influenza) within 2 weeks prior to receiving study dose injection.
• Planning to receive booster doses of any authorized COVID-19 vaccine during the first two months days from study vaccination.
• Has a history of any reaction or known sensitivity likely to be exacerbated by any component of the study vaccine.

Sponsors & Collaborators

• University of Saskatchewan: lead
• Government of Canada: collaborator
• Government of Saskatchewan: collaborator

Study Sites (4)

Diex Recherche Joliette Inc.

Joliette, Quebec, J6E 2B4, Canada

Location

Diex Recherche Quebec Inc.

Québec, Quebec, G1V 4T3, Canada

Location

Diex Recherche Sherbrooke

Sherbrooke, Quebec, J1L 0H8, Canada

Location

DIEX Recherche Victoriaville

Victoriaville, Quebec, G6P 6P6, Canada

Location

Related Publications (1)

• Garg R, Liu Q, Van Kessel J, Asavajaru A, Uhlemann EM, Joessel M, Hamonic G, Khatooni Z, Kroeker A, Lew J, Scruten E, Pennington P, Deck W, Prysliak T, Nickol M, Apel F, Courant T, Kelvin AA, Van Kessel A, Collin N, Gerdts V, Koster W, Falzarano D, Racine T, Banerjee A. Efficacy of a stable broadly protective subunit vaccine platform against SARS-CoV-2 variants of concern. Vaccine. 2024 Aug 13;42(20):125980. doi: 10.1016/j.vaccine.2024.05.028. Epub 2024 May 19.

  PMID: 38769033 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

COVAC-1 COVID-19 vaccine

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director & CEO Vaccine and Infectious Disease Organization

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 20, 2023
• Study Start: January 31, 2023
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)