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Clinical Trial to Study the COVAC-2 Booster Dose (for COVID-19) in Generally Healthy Adults.

NCT05226702 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-03

No results posted yet for this study

Summary

VIDO has developed a vaccine called COVAC-2.

The COVAC-2 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-2 contains a SWE adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The SWE adjuvant is similar to another adjuvant, MF59, that is found in influenza vaccines and MF59 containing vaccines have been given to millions of people around the world. 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 severe COVID-19 illness. In animal studies, the immune response generated by the COVAC-2 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection.

This is a Phase 1/2, placebo-controlled, observer-blind, age-stratified randomized, multicenter study to access the safety and immunogenicity of two dosing levels (10 and 25 µg S1 protein tested in parallel) administered once in healthy adults ≥18 of age who have received 2 doses of an authorized COVID-19 vaccine at least 6 months earlier. The study will also include an open-label exploratory study arm to evaluate safety and immunogenicity of a single COVAC-2 dose in previously SARS-CoV-2-infected individuals (Phase 2 only).

Conditions

  • Double Vaccinated for COVID-19 (For Phase 1 of the Study)
  • Acute Respiratory Syndrome Coronavirus 2 (For Phase 2 Exploratory Group)

Interventions

BIOLOGICAL

COVAC-2

Intramuscular vaccine against SARS-CoV-2

BIOLOGICAL

Saline Placebo

Intramuscular injection of saline placebo

Sponsors & Collaborators

  • Government of Canada

    collaborator OTHER_GOV

  • Government of Saskatchewan

    collaborator OTHER_GOV

  • Vaccine Formulation Institute (VFI)

    collaborator UNKNOWN

  • Seppic

    collaborator INDUSTRY

  • University of Saskatchewan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2023-11-13
Completion
2023-11-13

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05226702 on ClinicalTrials.gov