COVID-19 vaccine study, analyzing third dose booster options for 12 to 15-year-olds, is open at Royal Manchester Children’s Hospital.
This latest study arm of the University of Oxford-led Com-COV program is testing multiple options for third booster dose of COVID-19 vaccines for young people.
Current UK Government guidance is that children and young people aged 12 to 17 years old receive two doses of vaccine, eight weeks apart.
Participants in the Com-COV 3 study – who have previously received two doses of Pfizer-BioNTech vaccine, at least three months before – will receive a third dose of either:
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 then examine reactions and immune response of vaccine combinations.
The study is single-blind and randomised, meaning participants will not know what third dose vaccine they are receiving until three months later.
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. This includes Royal Manchester Children’s Hospital, which is part of Manchester University NHS Foundation Trust (MFT).
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 across Greater Manchester 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.”
As well as analyzing the immune system responses to these new combinations of vaccines, as well as any potential side effects, researchers 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 COVID-19 Vaccination Programme, Joint National Infection Specialty Lead and Consultant in Infectious Diseases and Tropical Medicine at North Manchester General Hospital – part of MFT – 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.”
Professor Indi Banerjee, Consultant Paediatric Endocrinologist, is Principal Investigator of Com-COV 3 at Royal Manchester Children’s Hospital – meaning he leads the study locally – he said: “We are tremendously proud that this nationally important trial is now open here at Royal Manchester Children’s Hospital.
“I encourage teenagers from across our region to considering being a part of this research and playing a role in the future of clinical care.”
All those who are interested in participating in this research can register via the study website: comcovstudy.org.uk.