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A Clinical Trial of COVAC-2 in Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT05209009•University of Saskatchewan

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Generally healthy male and female adults aged 18 years of age or older at the time of signing the informed consent form;
•2. Good general health as determined by screening evaluation not greater than 30 days before injection of first dose;
•Note: Participants who are overtly healthy as determined by medical evaluation or are considered medically stable according to the judgment of the investigator. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment, and/or hospitalization within the entire study period is not anticipated. Also, the participant appears likely to be able to remain in follow-up through the end of protocol-specified period. Mild to moderate well-controlled comorbidities are allowed.
•3. If female of child-bearing potential and heterosexually active, practice of adequate contraception for 30 days prior to injection, negative pregnancy test on the day of injection, and agreement to continue adequate contraception until 180 days after the second injection;
•4. Male participants are eligible to participate in the study if they agree to the following requirements during the study period and for at least 28 days after the last injection of study dose, i.e.,
•o Be abstinent from any heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle.
•OR
•o Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. In addition to male condom use, a highly effective method of contraception should be considered in women of child-bearing potential partners of male participants.
•AND
•o Must refrain from donating sperm; and
+1 more criteria

Exclusion Criteria

•1. Presence of any febrile illness or any known or suspected acute illness on the day of any immunization;
•2. Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
•3. Any condition, which in the opinion of the Investigator, may make the participant inappropriate for the study;
•4. Receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents;
•5. Receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months;
•6. Cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed;
•7. Presence of autoimmune disease;
•8. Receipt of any investigational drug within 6 months;
•9. Receipt of any non-COVID-19 authorized vaccines within 2 weeks of receiving study dose injection;
•10. Receipt of any authorized COVID-19 vaccine prior to study enrollment;
+6 more criteria

Locations (2)

Uganda Virus Research Institute

Entebbe, Uganda

Epicentre, Mbarara Research Centre

Mbarara, Uganda

Key Dates

Start Date

August 24, 2022

Primary Completion Date

March 1, 2024

Completion Date

March 1, 2024

Last Updated

May 2, 2024

Enrollment

150

ACTUAL participants

Conditions

Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

COVAC-2

BIOLOGICAL

Saline Placebo

BIOLOGICAL

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants

NCT05677893

Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (Disorder)

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COMPLETEDPHASE2/PHASE3

Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial

NCT04466241

COVID-19COVID-19 Drug Treatment+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Trial of COVAC-2 in Adults

Inclusion Criteria

Exclusion Criteria

A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled MBS-COV (SNS812) in Healthy Participants

Combination Therapies to Reduce Carriage of SARS-Cov-2 and Improve Outcome of COVID-19 in Ivory Coast: a Phase Randomized IIb Trial

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

COVID-19 Recovery Study: Symptoms and Biomarkers of Long COVID-19 in People Living With and Without HIV

Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients

Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19