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Com-COV vaccine study recruiting in Southampton to analyse 3rd dose booster options for 12 to 15 year-olds

  • Com-COV 3 to test multiple options for third booster dose COVID-19 vaccines for young people aged 12 to 15 years – with volunteers in Southampton
  • Participants that have received two doses of the Pfizer-BioNTech vaccine will receive either a:
    - further full adult dose Pfizer-BioNTech vaccine (30 mcg)
    - one-third adult dose Pfizer-BioNTech vaccine (10 mcg)
    - full child dose Pfizer-BioNTech vaccine (10 mcg)
    - full dose Novavax vaccine
    - meningitis vaccine, followed by a dose of Pfizer-BioNTech COVID-19 vaccine later in the study (control group)
  • Researchers will examine reactions and immune response of vaccine combinations

Researchers in Southampton 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 living in and around Southampton are being invited to take part in the study, which is running at University Hospital Southampton NHS Foundation Trust (UHS).

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.

Professor Saul Faust, local trial lead and Clinical Director of the NIHR Clinical Research Network (CRN) Wessex, 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 to check if their eligible.”

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 Southampton 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.

Professor Andrew Ustianowski, NIHR Clinical Lead for the 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, 2 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) provide 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.

All those who are interested can register via the study website: