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The purpose of this study is to to evaluate the safety and immune response of COVI-VAC given as a single booster dose in healthy adults previously vaccinated against COVID-19 with an authorised mRNA or adenovirus-vectored vaccine. Approximately 30 participants who have been fully vaccinated ≥ 3 months ago will be enrolled and receive one dose of COVI-VAC. COVI-VAC is administered by drops into each nostril. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 7 days after receiving COVI-VAC or placebo.
During the full study safety laboratory tests, physical exams, and vital signs (including oxygen saturation) will be conducted periodically for safety. Adverse events and medication use will be recorded.
Blood samples and intranasal samples will be collected periodically to assess the immune response from the vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVI-VAC | Experimental | COVI-VAC Nose Drops |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVI-VAC | Biological | Intranasal, live attenuated vaccine against SARS-CoV-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humoral Immunogenicity | IgG Titer measured by ELISA on day 1 | Day 1 |
| Humoral Immunogenicity | IgG Titer measured by ELISA on day 29 | Day 1 |
| Humoral Immunogenicity | IgG Titer measured by ELISA on day 181 | Day 181 |
| Humoral Immunogenicity measured by neutralizing antibodies | neutralising antibody titer measured by microneutralisation assay in serum on days 1 | Day 1 |
| Humoral Immunogenicity measured by neutralizing antibodies | neutralising antibody titer measured by microneutralisation assay in serum on day 29 | Day 29 |
| Humoral Immunogenicity measured by neutralizing antibodies | neutralising antibody titer measured by microneutralisation assay in serum on day 181 | Day 181 |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine and Virus Shedding | SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 4 | Day 4 |
| Vaccine and Virus Shedding |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HMR | London | United Kingdom |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000721867 | COVI-VAC |
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SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 8
| Day 8 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |