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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Intranasal, live attenuated vaccine against SARS-CoV-2
HMR
London, United Kingdom
Humoral Immunogenicity
IgG Titer measured by ELISA on day 1
Time frame: Day 1
Humoral Immunogenicity
IgG Titer measured by ELISA on day 29
Time frame: Day 1
Humoral Immunogenicity
IgG Titer measured by ELISA on day 181
Time frame: Day 181
Humoral Immunogenicity measured by neutralizing antibodies
neutralising antibody titer measured by microneutralisation assay in serum on days 1
Time frame: Day 1
Humoral Immunogenicity measured by neutralizing antibodies
neutralising antibody titer measured by microneutralisation assay in serum on day 29
Time frame: Day 29
Humoral Immunogenicity measured by neutralizing antibodies
neutralising antibody titer measured by microneutralisation assay in serum on day 181
Time frame: Day 181
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
Time frame: Day 4
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 8
Time frame: Day 8
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