COVID-19, SARS-CoV-2
Conditions
Keywords
Covid-19 vaccines, Covid-19 vaccine booster shot, Heterologous prime boost, COVID-19 vaccination, Vaccines, attenuated
Brief summary
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.
Interventions
BIOLOGICALCOVI-VAC
Intranasal, live attenuated vaccine against SARS-CoV-2
Sponsors
Codagenix, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF 2. Body mass index (BMI) ≤ 35 kg/m2 3. In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), and safety laboratory tests as determined by the Investigator 4. Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1
Exclusion criteria
1. Residents of residential care facilities 2. Pregnant or lactating women 3. Inadequate venous access for repeated phlebotomy 4. History of confirmed or suspected SARS-CoV-2 infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral Immunogenicity | Day 1 | IgG Titer measured by ELISA on day 1 |
| Humoral Immunogenicity measured by neutralizing antibodies | Day 1 | neutralising antibody titer measured by microneutralisation assay in serum on days 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine and Virus Shedding | Day 4 | SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 4 |
Countries
United Kingdom
Outcome results
None listed