Status:
COMPLETED
Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19
Lead Sponsor:
Codagenix, Inc
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 o...
Eligibility Criteria
Inclusion
- Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF
- Body mass index (BMI) ≤ 35 kg/m2
- 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
- Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1
Exclusion
- Residents of residential care facilities
- Pregnant or lactating women
- Inadequate venous access for repeated phlebotomy
- History of confirmed or suspected SARS-CoV-2 infection
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05233826
Start Date
April 14 2022
End Date
December 22 2022
Last Update
January 13 2023
Active Locations (1)
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1
HMR
London, United Kingdom