Vaccine trial to investigate a booster for teenagers to protect against COVID-19

Researchers running the University of Oxford-led Com-COV programme have launched a further national study assessing different options for a (third dose) booster vaccination for young people aged 12 to 15.

Backed through funding from the Vaccines Taskforce and National Institute for Health Research (NIHR), the Com-COV 3 trial will seek to recruit 270 volunteers across the UK.

In Wales, up to 40 volunteers are being sought by Public Health Wales and Cardiff and Vale University Health Board to take part in the trial, which will take place at Noah’s Ark Children’s Hospital for Wales.

This study will look at participants immunised with two doses of Pfizer-BioNtech vaccine to be randomly allocated to receive either a:

• further full adult dose Pfizer-BioNTech vaccine
• one-third adult dose Pfizer-BioNTech vaccine
• full child dose Pfizer-BioNTech vaccine
• full dose Novavax vaccine
• meningitis vaccine, followed by a dose of Pfizer-BioNTech COVID-19 vaccine later in the study (control group)

In Wales, all young people aged 12 to 15 are currently being offered two vaccine doses.  This study will seek to answer whether a booster dose of vaccine should be added to the standard two doses now being rolled out for this age group.

Rhian Thomas-Turner the Research and Development Lead at Noah’s Ark Hospital for Wales, said: “In this study, participants would need to make up to six visits to Noah’s Ark Hospital for Wales. Researchers will analyse any side effects and immune system responses to these new combinations of vaccines.”

Dr Nicola Williams, National Director of Support & Delivery at Health and Care Research Wales, said: “This study builds on the previous national studies Wales has contributed to looking into the most effective combination of vaccines.

“From our experience young people in Wales want to do all they can to help us continue to try and understand COVID-19.  We would like to encourage anyone interested to visit the website to check their eligibility.”

The study investigators anticipate reporting initial results in 2022. If the results are promising, regulators the Medicines and Healthcare products Regulatory Agency (MHRA) and the Joint Committee on Vaccination and Immunisation (JCVI) would formally assess the efficacy of any new vaccination process before advising whether it is rolled out to patients.

Those who are interested in volunteering can register via the study website.

A patient information leaflet with further information is attached but if you would like an informal chat with one of the paediatric study team in Cardiff or have any questions about the study please contact: comcov3.hcrw@wales.nhs.uk