ZosterFluCOV trial
Research type
Research Study
Full title
A phase IV, multi-centre, randomised controlled trial to assess immunogenicity and safety of COVID-19 and seasonal influenza vaccine given to healthy adults or those with underlying medical conditions when co-administered with a recombinant herpes zoster vaccine with adjuvant
IRAS ID
1006696
Contact name
Rajeka Lazarus
Contact email
Sponsor organisation
University Hospitals Bristol and Weston NHS Foundation Trust
ISRCTN Number
ISRCTN26495549
Research summary
Shingles is a common and painful disease, it can result in long-term pain and in rare cases can even be fatal. It is recommended that all adults in the UK are offered the shingles vaccine on their 70th birthday. Uptake of the shingles vaccine is suboptimal, therefore strategies to improve uptake are needed.
Routine reporting of the shingles vaccine suggests that uptake is greater during the influenza season, and it is assumed this is due to it being offered at the same time as the annual flu vaccine. A new vaccine for shingles has been recommended since 2021, a recombinat herpes zoster vaccination. However, co-administration with either a COVID-19 booster vaccine or influenza vaccine is not recommended due to a lack of data.
The purpose of the ZosterFluCOV study is to see what side effects, such as fever and tiredness, people get when they are given the shingles vaccination at the same time as the currently recommended flu vaccine or COVID-19 booster. We will also look at people’s immune responses to the vaccines when given together.
We will be enrolling people that are aged 50 and over. In order to take part in the study you must not have received a shingles vaccine within 5 years of your enrolment in the study. Participants will be required to attend 6 study appointments over a period of 5 months at their nearest participating site. They will be randomly allocated into one of five groups, and they do not know which group they are in. Participants will be required to provide blood samples at each study visit, and complete an e-diary in-between visits. We hope to recruit 1032 participants into the study. The study will be conducted in at least 15 sites. The study is expected to take 28 months in total.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0409
Date of REC Opinion
26 May 2023
REC opinion
Further Information Favourable Opinion