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

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).

Timeline

Start

2022-07-22

Primary completion

2023-11-13

Completion

2023-11-13

Publications

• Hamonic G, Arora S, Garg R, Scruten E, Buchanan R, Saundh SL, Collin N, Sanche S, Vale N, Salter T, Halperin SA, Langley JM, Gerdts V, Racine T. Safety and immunogenicity of a booster dose of COVAC-2, a Sepivac SWE adjuvanted SARS-CoV-2 recombinant protein vaccine in previously vaccinated healthy adults; a randomized controlled multicentre trial. Hum Vaccin Immunother. 2026 Dec;22(1):2683765. doi: 10.1080/21645515.2026.2683765. Epub 2026 Jun 10.
• 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.

Drugs

Indications