Researchers in Southampton have launched a new study of COVID-19 vaccine schedules in young people.
Comparing different boosters and doses The Com-COV 3 study has been commissioned through the National Institute for Health and Care Research (NIHR). It aims to recruit 380 volunteers across nine NIHR-supported sites. University Hospital Southampton NHS Foundation Trust (UHS) is one of these sites.
All participants will have received two doses of the Pfizer-BioNTech vaccine, at least three months before joining. Researchers will give a third vaccine dose as part of the study.
They will be randomly allocated to receive either a full adult dose, one-third adult dose or full child dose of the Pfizer-BioNTech vaccine, or a full dose of the Novavax vaccine.
A control group will receive a meningitis vaccine (Bexsero, against MenB bacteria), followed by a Pfizer-BioNTech COVID-19 vaccine later in the study.
The study is single-blind and randomised. This means participants will not know what third dose vaccine they are receiving until three months later.
Researchers will check for any side effects and analyse immune system responses to these new combinations of vaccines. They will also examine if a one-third adult dose of the Pfizer-BioNTech vaccine is at least as good as a full child dose of the same vaccine.
Professor Saul Faust, local trial lead and Director of the NIHR Clinical Research Facility (CRF) at UHS, said:
“We’re looking for around 75 12 to 15 year olds living in the Southampton area to support us with the next phase of the Com-COV study.
“The purpose of this study is to compare the immune responses of young people to different COVID-19 booster vaccines and doses, to help us find out the best way of further protecting them and their families from COVID-19.
“Throughout the pandemic, we have been amazed by the response from the people of Southampton, who continue to step forward to support our trials. We cannot thank them enough for giving up their time to support such important research.
“Initial results from this study, expected later in 2022, will allow us to understand how young people respond to a third booster dose and help inform the delivery of any future booster campaigns in this age group.
“Anyone interested in taking part in this study or finding out more, can visit the study website comcovstudy.org.uk to check if they’re eligible.”
The study investigators anticipate reporting initial results in 2022. The UK’s regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA) rigorously assess the safety and efficacy of any new vaccine before considering market authorisation and subsequent rollout to patients.
The Joint Committee on Vaccination and Immunisation (JCVI) provide expert guidance to UK health departments on vaccination. They take into account a range of evidence, including data from trials undertaken to understand the immunological impact of booster vaccinations.
All those who are interested can register via the study website: comcovstudy.org.uk