NCT05693272

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

Completed Phase 1 Last updated 5 December 2024

What this trial tests

Phase 1 trial testing COVAC-1 in Severe Acute Respiratory Syndrome Coronavirus 2 Infection in 47 participants. Completed in 4 June 2024.

Timeline

31 January 2023

Primary endpoint
4 June 2024

4 June 2024

Quick facts

Lead sponsor	University of Saskatchewan
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	prevention
Enrollment	47
Start date	31 January 2023
Primary completion	4 June 2024
Estimated completion	4 June 2024
Sites	4 locations across Canada

Drugs / interventions tested

• COVAC-1 — full drug profile →
• Saline Placebo

Conditions studied

• Severe Acute Respiratory Syndrome Coronavirus 2 Infection — all drugs for Severe Acute Respiratory Syndrome Coronavirus 2 Infection →

Sponsor

University of Saskatchewan

Who can join

Adults 18 to 65, any sex, with Severe Acute Respiratory Syndrome Coronavirus 2 Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Vaccine adjuvants for infectious disease in the clinic.
   Goetz M, Thotathil N, Zhao Z, Mitragotri S. · · 2024 · cited 29× · PMID 39036089 · DOI 10.1002/btm2.10663