NCT05226702

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

A Phase 1 Clinical Trial to Study the Safety and Immunogenicity of a COVAC-2 Booster Dose in Generally Healthy Adults.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	COVAC-2	Intramuscular vaccine against SARS-CoV-2
BIOLOGICAL	Saline Placebo	Intramuscular injection of saline placebo

Timeline

• Start date: 2022-07-22
• Primary completion: 2023-11-13
• Completion: 2023-11-13
• First posted: 2022-02-07
• Last updated: 2024-05-03

Locations

3 sites across 1 country: Canada