COVID -19 Respiratory COVID -19
Conditions
Interventions
PLACEBO
COVAC
Sponsors
University of Saskatchewan Vaccine and Infectious Disease Organization
Eligibility
Sex/Gender
All
Inclusion criteria
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 (i.e., 18 to 54 for Arm 1a and =55 for Arm 1b); 2. Good general health as determined by screening evaluation no 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 hospitalization 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.Written informed consent, after review of the consent form and having adequate opportunity to discuss the study with an Investigator or a qualified designee
Exclusion criteria
Exclusion criteria: 1. Presence of any febrile illness or any known or suspected acute illness on the day of any immunization; 2. Any immunodeficiency (congenital or acquired) disease, disorder, or finding that may significantly increase the risk of study participant or, in the Investigator’s judgment, make the participant inappropriate for the study; 3. 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; 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 prior to injection of first dose; 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; 11. Receipt of any other experimental SARS-CoV-2/COVID-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; 12. Receipt of blood products or immunoglobulin (IVIg or IMIg) within 3 months of study entry/baseline serologic evaluation;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events (AEs) from the first injection to Day 28, in all participants, in all groups: o The occurrence of each solicited local and general AE, during each 7-day follow-up period after injection (e.g., the day of injection and 6 subsequent days). o The occurrence of any unsolicited AEs for the entire study period. o The occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil, and platelet count) and biochemical (ALT, AST, BUN, and Cr) clinically significant laboratory abnormality through to Day 28 and; o The occurrence of any serious AEs (SAEs) medically attended events (MAE), or adverse event of special interest (AESI) through to Day 365. • Occurrence of AEs from the second injection to Day 56 (28 days post injection), in all participants, in all groups: o The occurrence of solicited local and general AE, during each 7-day follow-up period after the second injection (e.g., the day of 2nd injection and 6 subsequent days); o The occurrence of any unsolicited AEs for the entire study period and; o The occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil, and platelet count) and biochemical (ALT, AST, BUN, and Cr) clinically significant laboratory abnormality through to Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| The immune response to the study vaccine, as measured by antibody (e.g., IgG and other isotypes) directed to Wuhan spike antigen or neutralizing antibodies preinjection (Day 0) and post-injection(s) (Days 14, 28, 35, 42, 56, 90, 120, and 365); • The immune response to the study vaccine, as measured by cell immune response markers in PBMCs collected pre-injection (Day 0) and post-injection (Days 14, 28, 35, 42, 120 and 365). | — |
Countries
Kenya
Contacts
Public ContactValerie Awuondo
Kenya AIDS Vaccine Initiative Institute of Clinical Research
Outcome results
None listed