Clinical Trial to Study the COVAC-2 Booster Dose (for COVID-19) in Generally Healthy Adults.
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: COVAC-2 10 µg group 20 healthy adults ≥18 years of age receive the vaccine on Day 0. |
Biological: COVAC-2
Intramuscular vaccine against SARS-CoV-2
|
| Experimental: COVAC-2 25 µg group 20 healthy adults ≥18 years of age receive the vaccine on Day 0 |
Biological: COVAC-2
Intramuscular vaccine against SARS-CoV-2
|
| Placebo Comparator: Placebo Control 20 healthy adults ≥18 years of age receive a dose of normal saline (placebo) on Day 0. |
Biological: Saline Placebo
Intramuscular injection of saline placebo
|
Outcome Measures
Primary Outcome Measures
- Assessment of the safety and tolerability of COVAC-2 booster vaccine in generally healthy volunteers [Up to 365 days]
Incidence of solicited adverse events (AE) up to 7 days post-injection; unsolicited AEs up to 28 days post-injection; any clinically significant laboratory finding up to 28 days post-injection; and any serious AEs (SAEs), potential immune medicated disease (pIMDs) or COVID-19 illness up to 365 days.
Secondary Outcome Measures
- To assess the spike binding and neutralizing response induced by COVAC-2 booster vaccine [Up to 365 days]
Antibody response induced by COVAC-2 booster pre-injection and post injection as measured by spike protein-specific Enzyme Linked Immunosorbent Assay (ELISA), virus microneutralization and/or pseudovirus neutralization assay.
- To assess the immune response induced by COVAC-2 booster vaccine, as measured by cell immune response markers up to Day 365. [Up to 365 days]
Measurement of COVAC-2 immune response by measuring cell-mediated response markers in Peripheral Blood Mononuclear Cells (PBMCs) pre- and post-injection.
Other Outcome Measures
- To assess the induction of SARS-CoV-2 Receptor Binding Domain (RBD) antibodies following the booster dose of COVAC-2 vaccine [Up to 365 days]
SARS-CoV-2 RBD antibodies collected pre- and post-injection as measured by RBD protein-specific Enzyme Linked Immunosorbent Assay (ELISA).
- Assessment of the safety and immunogenicity of single dose of COVAC-2 vaccine in subjects previously infected with SARS-CoV-2. [Up to 365 Days]
Antibody response induced by COVAC-2 booster pre-injection and post injection as measured by RBD protein & spike protein-specific ELISA, virus neutralization assay against variant of concern, by measuring cell-mediated response markers in Peripheral Blood Mononuclear Cells (PBMCs).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Generally healthy male and female adults aged 18 years or older at the time of signing the informed consent form.
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Good general health as determined by screening evaluation no greater than 30 days before injection of study vaccine.
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.
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Have received 2 doses of an authorized COVID-19 vaccine at least 6 months prior to recruitment(not applicable for subjects in exploratory Phase 2 study arm).
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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 injection.
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Written informed consent, after review of the consent form and having adequate opportunity to discuss the study with an Investigator or a qualified designee.
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Exploratory Phase 2 study arm: Unvaccinated participants with a documented history of infection with SARS-COV-2 (positive PCR or serology for SARS-CoV-2) or positive rapid SARS-CoV-2 antibody test at screening.
Exclusion Criteria:
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Presence of any febrile illness or any known or suspected acute illness on the day of immunization.
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Any condition, which in the opinion of the Investigator may make the participant inappropriate for the study.
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Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
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Receiving systemic immunosuppressive therapy or history of receiving chemotherapy in the last 5 years other than topical agents.
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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 study vaccine.
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Cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
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Presence of autoimmune disease.
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Receipt of any investigational drug within 6 months.
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Receipt of any non-COVID-19 authorized vaccines, for example influenza, within 2 weeks of receiving study dose injection.
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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.
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Receipt of blood products or immunoglobulin (IVIg or IMIg) within 3 months of study entry/baseline serologic evaluation.
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Current anti-tuberculosis therapy.
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History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
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Hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. To exclude transient abnormalities, the Investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. Grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the Investigator.
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Known current or previous laboratory-confirmed SARS-CoV-1 OR SARS-CoV-2 infection, as documented by a positive polymerase chain reaction (PCR) test from a nasal swab (not applicable for subjects in exploratory Phase 2 study arm).
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Exploratory Phase 2 study arm: Known current or previous laboratory-confirmed SARS-CoV-1 infection, and known current laboratory-confirmed SARS-CoV-2 infection, as documented by a positive polymerase chain reaction (PCR) test from a nasal swab.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Saskatchewan
- Government of Canada
- Government of Saskatchewan
- Vaccine Formulation Institute (VFI)
- SEPPIC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COVAC-004