Evaluating COVID-19 Vaccine Boosters (Cov-Boost) [COVID-19]
Research type
Research Study
Full title
A randomised, phase II UK multi-centre study to determine reactogenicity and immunogenicity of booster vaccination against ancestral and novel variants of SARS-CoV-2
IRAS ID
299180
Contact name
Saul Faust
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Eudract number
2021-002175-19
ISRCTN Number
ISRCTN73765130
Duration of Study in the UK
1 years, 8 months, 29 days
Research summary
With the emergence of SARS-CoV-2 variants which may reduce vaccine efficacy against COVID-19, and with waning of immunity over time, it is likely that seasonal booster vaccines may be necessary for high risk groups.
This study is to determine the safety and immune responses seen when people receive a COVID-19 boost, depending on whether you received the Oxford or Pfizer vaccines for your original course of 2 vaccines (known as prime-boost). We are trialing 7 vaccines including some given as a half dose. Using a half dose would enable double the number of people to be vaccinated using the same amount of vaccine supply. The immune response from the COVID-19 vaccine boosters will be compared to a control group who will receive the Meningococcal ACWY vaccine.
The study will enrol people 30 years and older (including specifically people 75 years and older) who received their initial COVID-19 vaccine course between December 2020 and March 2021. They will be randomised to one of the COVID-19 vaccines or the control group. The study is "single blind", so participants will not know which vaccine they received. Participants will have blood tests at day 28, 84 and 365 to measure their immune response. A smaller cohort from each group will also have visits at day 7 and 14 for more detailed blood tests. We will assess symptoms in the following 7 days after vaccination.
The study protocol also contains plans for a second stage, which will take place if some of the vaccines planned for the first stage are unavailable.
Finally the protocol contains plans for a third stage, which will test vaccines specifically designed for SARS-CoV-2 variants as booster vaccines against the meningococcal ACWY vaccine as a control.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0171
Date of REC Opinion
13 May 2021
REC opinion
Favourable Opinion