NCT05209009

A Clinical Trial of COVAC-2 in Adults

A Randomized, Observer-Blind, Dose-Escalation Phase 2 Clinical Trial of COVAC-2 in Generally Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (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 2, placebo-controlled, observer-blind, age-stratified randomized, multicentre study to test the safety and immunogenicity of a dose level of the COVAC-2 vaccine (25 µg protein) administered twice (4 weeks apart) in generally healthy adults 18+ years of age. Up to 300 participants will be enrolled. For an individual participant, the duration of study will be approximately 12 months from the first vaccination (Day 0).

Conditions

• Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

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

Timeline

• Start date: 2022-08-24
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-01-26
• Last updated: 2024-05-02

Locations

2 sites across 1 country: Uganda