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Virus Therapy

COVAC-1 Booster for COVID-19

Phase 1
Waitlist Available
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to the investigational booster dose injection. Proof of vaccination can be provided as a digital copy of the vaccination receipt on the participant's device, a screenshot of the receipt on the device, or a printed paper copy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 365 days
Awards & highlights

Study Summary

This trial is testing a booster vaccine to help protect against COVID-19. It is a randomized and placebo-controlled study to test the safety and effectiveness of the vaccine in generally healthy adults.

Who is the study for?
Adults aged 18-65 in good health or with stable medical conditions, who've had at least two COVID-19 vaccine doses four months before the study. They must not be pregnant, agree to use contraception, and have no history of significant bleeding disorders, recent immunoglobulins or systemic immunomodulatory therapies.Check my eligibility
What is being tested?
The COVAC-1 booster dose is being tested for safety and immune response enhancement in adults previously vaccinated against COVID-19. The trial is randomized and placebo-controlled, comparing three dosage levels (10 µg, 25 µg, 50 µg) with participants assigned by chance to either the vaccine or a saline placebo.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical vaccine reactions such as soreness at injection site, fever, fatigue or allergic responses to components of the vaccine. Close monitoring will occur especially after initial doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have received at least 2 COVID-19 vaccine doses over 4 months ago.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of the safety of COVAC-1 booster vaccine (10, 25 and 50 μg dosing of S1 antigen) in generally healthy volunteers
Secondary outcome measures
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by pseudovirus neutralization assay.
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by spike protein-specific Enzyme Linked Immunosorbent Assay (ELISA)
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by virus microneutralization assay.
+2 more
Other outcome measures
To assess the neutralizing antibody response induced by COVAC-1 against the Omicron and/or the most relevant currently circulating Variants of Concern.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: COVAC-01 50µg groupExperimental Treatment1 Intervention
12 healthy adults ≥18 years of age receive the vaccine on Day 0.
Group II: COVAC-01 25µg groupExperimental Treatment1 Intervention
12 healthy adults ≥18 years of age receive the vaccine on Day 0.
Group III: COVAC-01 10µg groupExperimental Treatment1 Intervention
12 healthy adults ≥18 years of age receive the vaccine on Day 0.
Group IV: Placebo ControlPlacebo Group1 Intervention
12 healthy adults ≥18 years of age receive a dose of normal saline (placebo) on Day 0.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Government of CanadaOTHER_GOV
12 Previous Clinical Trials
2,320 Total Patients Enrolled
2 Trials studying COVID-19
96 Patients Enrolled for COVID-19
Government of SaskatchewanOTHER_GOV
4 Previous Clinical Trials
271 Total Patients Enrolled
1 Trials studying COVID-19
60 Patients Enrolled for COVID-19
University of SaskatchewanLead Sponsor
251 Previous Clinical Trials
154,363 Total Patients Enrolled
1 Trials studying COVID-19
60 Patients Enrolled for COVID-19

Media Library

COVAC-1 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05693272 — Phase 1
COVID-19 Research Study Groups: COVAC-01 10µg group, COVAC-01 25µg group, COVAC-01 50µg group, Placebo Control
COVID-19 Clinical Trial 2023: COVAC-1 Highlights & Side Effects. Trial Name: NCT05693272 — Phase 1
COVAC-1 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05693272 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree does the COVAC-01 50µg group present a hazard to individuals?

"In light of the limited data available, our team at Power assessed COVAC-01 50µg group's safety to be a score of 1. This is mainly due to it being in its first clinical trial stage."

Answered by AI

Are seniors aged 85 and older eligible to participate in this clinical experiment?

"As evidenced by the study's inclusion criteria, patients aged 18 to 65 are eligible. There is a separate pool of 119 trials specifically designed for people under 18 and 748 studies tailored towards individuals above 65 years old."

Answered by AI

Are there any open enrollment slots for this research initiative?

"Affirmative, public records on clinicaltrials.gov point to this medical trial actively searching for participants. As of March 23rd 2023, the study has been recruiting 48 patients from 4 distinct sites since it was first posted in January 31st 2023."

Answered by AI

Is it feasible for me to partake in this experiment?

"To qualify for this trial, enrollees must have contracted covid-19 and be between 18 to 65 years old. This clinical research is recruiting a total of 48 participants."

Answered by AI

To what extent is the population participating in this experiment?

"Affirmative. The information on clinicaltrials.gov affirms that this trial is actively seeking participants, having first been published on January 31st 2023 and last edited on March 23rd 2023. A total of 48 patients are expected to be enrolled from 4 sites participating in the study."

Answered by AI

How many geographical sites are presently engaged in this trial?

"This clinical study is presently enrolling patients in 4 diverse locations, such as Québec City, Sherbrooke and Victoriaville. To minimize travel burden on participants, it is advised to select a clinic closest to you."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Clinical Trial to Study the COVAC-1 Booster Dose in Generally Healthy Adults
Volker Gerdts 2023. "A Clinical Trial to Study the COVAC-1 Booster Dose in Generally Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05693272.
~3 spots leftby May 2024
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