Researchers running the University of Oxford-led Com-COV programme have started enrolling young people aged 12 to 16 years old to receive a second dose of a COVID-19 vaccine, including in Newcastle upon Tyne.
Backed through funding from the Vaccines Taskforce and National Institute for Health Research (NIHR) and run across several NIHR-supported sites by the National Immunisation Schedule Evaluation Consortium, the Com-COV 3 trial is seeking to recruit 270 volunteers. The study has already opened at six sites in the UK, and is expanding to nine new recruiting areas, with recruitment happening locally at The Great North Children’s Hospital, part of The Newcastle upon Tyne Hospitals NHS Foundation Trust.
Professor Matthew Snape, Associate Professor in Paediatrics and Vaccinology at the Oxford Vaccine Group, and Chief Investigator on the trial, said: “Teenagers are currently experiencing the highest rate of infections of all age groups in the UK. This study will be critical to delivering vital information on the range of options for immunising teenagers against COVID-19 in the UK to help control this. Therefore, we are asking for 12 to 16 years olds to take this opportunity to receive a second dose of vaccine and help us understand how best to immunise teenagers to protect them and their families.”
All participants will be randomly allocated at the time of their second dose to receive either a full second dose of the Pfizer vaccine, a one-third dose of the Pfizer vaccine, or a full dose of the Novavax vaccine. These vaccines will be administered at least eight weeks after their first dose, and sites hope to complete this stage of the study by early December.
The current UK guidance is that all 12 to 15 year olds receive a single dose of vaccine, while 16 to 17 year olds receive 2 doses of vaccine, 12 weeks apart. Younger people at a greater risk of serious illness if they catch COVID-19 are currently offered two doses. The results from the study will provide the JCVI (Joint Committee on Vaccination and Immunisation) with timely and crucial information about immunising teenagers in the UK.
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 once vaccinated against COVID-19.
“If you are interested in taking part in the study, please get in touch with the local research team at nuth.childrensresearchfacilitynewcastle@nhs.net.”
Professor Matthew Snape added: “We are very grateful to those young volunteers and their parents who have signed up for the study so far. We hope the addition of the trial site at The Great North Children’s Hospital in Newcastle upon Tyne will encourage even more participants to get involved in this critically important research.”
The study is single-blind and randomised, meaning participants will not know what second dose vaccine they are receiving. Researchers will assess reactogenicity (any side effects) and immune system responses to these new combinations of vaccines.
Professor Andrew Ustianowski, NIHR Clinical Lead for COVID-19 Vaccination Programme and Joint National Infection Specialty Lead, said: “By getting involved in this study, volunteers will be able to help researchers develop our understanding of how we can best protect teenagers against COVID-19.”
All those who are interested can register via the study website comcovstudy.org.uk
