COVID-19 vaccine booster study recruiting 12 to 15 year-olds in Oxford
A new study on different options for a third dose COVID-19 booster vaccination in young people aged 12 to 15 has begun recruiting at the Churchill Hospital, Oxford.
The University of Oxford-led Com-COV 3 study, supported by the National Institute for Health and Care Research (NIHR), aims to recruit 380 volunteers across nine UK sites.
All will have received two doses of the Pfizer-BioNTech vaccine, at least three months before joining. Researchers will deliver a third dose as part of the study.
The trial’s chief investigator Professor Matthew Snape, of the University of Oxford’s Oxford Vaccine Group, 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 Oxford 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.”
Participants will be randomly allocated to receive a full dose of the Novavax vaccine or a full, one-third or child dose of the Pfizer-BioNTech vaccine. A control group will receive a meningitis vaccine followed by a Pfizer-BioNTech COVID-19 vaccine later in the study.
Participants will not know which vaccine they receive until three months later. Researchers will analyse the immune system responses and any side effects to these new vaccine combinations. They will also examine if a one-third adult dose is as good as a full child dose of the Pfizer-BioNTech vaccine.
Professor Andrew Ustianowski, NIHR Clinical Lead for COVID-19 Vaccination Programme and Joint National Infection Specialty Lead, said: “It's very important that continued research into how we can best protect teenagers against COVID-19 takes place. The Com-COV 3 study will help us to develop a better understanding of adolescents immunity when it comes to booster jabs.
“Thousands of volunteers are still stepping forward for a number of vaccine booster studies, two years on since we began to recruit into the first COVID-19 vaccine studies. Their time, support and generosity has been immense and helps us build upon the science of vaccine combinations. The latest stage of the Com-COV 3 study will be key to providing important data on protecting young people and their families.”
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.
Those interested can register via comcovstudy.org.uk
