COVI-VAC: safety and immune response to COVID-19 [21-012]
Research type
Research Study
Full title
Phase 1 Study Evaluating the Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19. (21-012)
IRAS ID
306439
Contact name
Sybil Tasker
Contact email
Sponsor organisation
Codagenix Inc
Eudract number
2021-005909-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
COVI-VAC (the study vaccine) is an experimental new vaccine for COVID-19, a viral infectious disease caused by a new strain of coronavirus (COVID-19 virus). Most people with COVID-19 only have mild illness and recover without treatment. Some people, like the elderly or those with health problems, can become seriously ill. COVID-19 vaccines provide protection against serious disease. However, this protection can reduce over time and may not be as strong against new variants of the virus. All currently available COVID-19 vaccines are given by injection.
COVI-VAC is a type of vaccine called a ‘live attenuated vaccine’, which is a weakened form of the COVID-19 virus. 36 healthy adults have had COVI-VAC before – there were no important side effects. We hope it can be used as a ‘booster’ vaccine to provide longer term protection from COVID-19, and that it’ll be more effective than existing vaccines against new variants of the virus. The study vaccine has the benefit of being given as drops into the nostrils rather than by injection.
We’ll give single doses of COVI-VAC to 30 healthy adult participants (aged 18–65) who’ve already had 2 doses of an existing COVID-19 vaccine. Participants will be given COVI-VAC (or placebo) as drops in each nostril. We aim to find out the side effects of COVI-VAC, its effect on the body’s immune response to the COVID-19 virus, and, whether people release the weakened study vaccine virus into the air (a process called ‘shedding’).
Participants will stay on the ward overnight before their dose and make 3 outpatient visits 3, 7 and 28 days after their dose. They’ll come back to the ward for a final follow-up visit 6 months after their dose.
A pharmaceutical company (Codagenix Inc.) is funding the study.
The study will take place at 1 centre in London.REC name
London - Fulham Research Ethics Committee
REC reference
21/HRA/4262
Date of REC Opinion
7 Feb 2022
REC opinion
Further Information Favourable Opinion