Com-COV vaccine study recruiting in Newcastle to analyse 3rd dose booster options for 12 to 15 year-olds
Researchers running the University of Oxford-led Com-COV programme have launched a new study of COVID-19 vaccine schedules in young people aged 12 to 15 – with a focus on assessing different options for a third dose booster vaccination.
Volunteers are being invited to take part in the study locally at The Great North Children’s Hospital, part of The Newcastle upon Tyne Hospitals NHS Foundation Trust.
The Com-COV 3 study has been commissioned through the National Institute for Health and Care Research (NIHR) and aims to recruit 380 volunteers across nine NIHR-supported sites. All participants will have received two doses of the Pfizer-BioNTech vaccine, at least three months before joining. Researchers will deliver a third vaccine dose as part of the study.
Matthew Snape, Professor in Paediatrics and Vaccinology at the University of Oxford, and Chief Investigator of the trial, said: “This study builds on the important results from previous studies, which have directly informed the national and international use of mixed COVID-19 vaccine schedules. These studies have included teenagers receiving the first two vaccine doses.
“A key question for teenagers now is how well they respond to different options for a third dose of vaccine – and we now need the help of young people in Newcastle to help us answer this. If these can be shown to produce a strong immune response with fewer temporary side effects, then this could improve the acceptability and uptake of a third dose adolescent campaign, both in the UK and internationally.”
All participants 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 analyse the reactogenicity (any side effects) and 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.
Dr Stephen Owens, Principal Investigator of the study at The Newcastle upon Tyne Hospitals NHS Foundation Trust, said: “It is important to establish the most effective vaccine doses for different population groups, and this latest study will help develop our understanding of immune responses for young people following a third booster dose.
“If you are interested in taking part in the study, please get in touch with the local research team at email@example.com or visit the study website.”
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) provides expert guidance to UK health departments on vaccination, which takes into account a range of evidence, including data from trials undertaken to understand the immunological impact of booster vaccinations.