Com-COV alternating vaccine schedule study for 12-to-16-year-olds launches at St George’s
Researchers at St George’s are to begin running the latest University of Oxford-led Com-COV study, looking into different COVID-19 vaccination schedules for young people aged 12 to 16.
Running at St George’s University Hospitals NHS Foundation Trust, the Com-COV 3 trial will seek to recruit 360 volunteers nationally. The study is backed through funding from the Vaccines Taskforce and National Institute for Health Research (NIHR) and by the National Immunisation Schedule Evaluation Consortium.
Participants can either receive two COVID-19 vaccine doses in the study, in which case their first dose will be the Pfizer COVID-19 vaccine. Alternatively, those who have already received a dose of the Pfizer COVID-19 vaccine through the NHS can be enrolled at the time of their second dose.
All participants will be randomly allocated at the time of the second dose to receive either a full dose or half dose of the Pfizer-BioNTech vaccine, a full dose of the Novavax vaccine or a half dose of the Moderna vaccine.
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 different vaccine combinations.
Professor Matthew Snape, Associate Professor in Paediatrics and Vaccinology at the University of Oxford, and Chief Investigator on the trial, said:
“This study will provide vital information on the range of options for immunising teenagers against COVID-19 in the UK.
“As well as looking at the standard two full doses of the Pfizer vaccine, we will look at how well volunteers respond when their second dose of Pfizer is half that of the first dose, or if different vaccines are used altogether, such as the vaccines manufactured by Moderna or Novavax. This will provide the JCVI with information crucial to informing their advice about immunising teenagers in the UK.”
“This is the latest in a series of studies such as Com-COV and COV-BOOST that have looked at ways the different COVID-19 vaccines available in the UK can be used to generate the best and most durable immune response, in as safe a manner as possible.”
Professor Andrew Ustianowski, NIHR Clinical Lead for COVID-19 Vaccination Programme and Joint National Infection Specialty Lead, 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.
“We continue to see valuable contributions from volunteers across COVID-19 vaccine research across the UK to help us identify the best vaccine schedules, and I hope we see similar levels of engagement with the Com-Cov 3 study.”
Professor Paul Heath, Professor of Paediatric Infectious Diseases at St George’s, University of London and Principal Investigator for the Com-Cov 3 study at St George’s Hospital, said:
“We need to find out which of several different COVID-19 vaccines are best to provide sufficient immunity when given as a second dose to young people aged 12 and above. The Com-Cov 3 study will provide vital evidence that will help us identify the best vaccine schedules for protecting the next generation against this disease.”
The study hopes to report initial results by December – if the results are promising, regulators MHRA and JCVI would formally assess the safety and efficacy of any new vaccination process before advising whether it is rolled out to patients.
Those who are interested can register via the study website https://comcovstudy.org.uk
Notes to editors
For an interview with the lead researchers from the University of Oxford, please contact: news.office@admin.ox.ac.uk
Please contact NIHR CRN South London’s Communications Manager Lewis Deakin via lewis.deakin@nihr.ac.uk for more information.
The four different sites in the trial, are as follows:
– St George’s University Hospitals NHS Foundation Trust
– University Hospitals Bristol and Weston NHS Foundation Trust
– University Hospital Southampton NHS Foundation Trust
– Oxford Vaccine Group, University of Oxford.
About the National Institute for Health Research
The mission of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
About the Oxford Vaccine Group
The Oxford Vaccine Group (OVG) conducts studies of new and improved vaccines for children and adults and is based in the Department of Paediatrics at the University of Oxford. The multidisciplinary group includes consultants in vaccinology, a Director of Clinical Trials, a Senior Clinical Trials Manager, adult and paediatric clinical research fellows, adult and paediatric research nurses, project managers, statisticians, QA manager, Clinical Trials IT and Development Lead, and an administration team. The team also includes post-doctoral scientists, research assistants and DPhil students and we work together with professionals from a range of specialities such as immunologists, microbiologists, epidemiologists, health communicators, and a sociologist, a community paediatrician, the local Health Protection team and a bioethicist.
OVG is a UKCRC registered clinical trials unit working in collaboration with the Primary Care Trials Unit at the University (registration number: 52).
About the Vaccines Taskforce
The Vaccines Taskforce (VTF) is a joint unit in the Department for Business, Energy and Industrial Strategy (BEIS) and Department for Health and Social Care (DHSC). The VTF was set up to ensure that the UK population has access to clinically effective and safe vaccines as soon as possible, while working with partners to support international access to successful vaccines.
The Vaccines Taskforce comprises a dedicated team of private sector industry professionals and officials from across government who are working at speed to build a portfolio of promising vaccine candidates that can end the global pandemic.
The Vaccines Taskforce’s approach to securing access to vaccines is through:
- procuring the rights to a diverse range of promising vaccine candidates to spread risk and optimise chances for success
- providing funding for clinical studies, diagnostic monitoring and regulatory support to rapidly evaluate vaccines for safety and efficacy
- providing funding and support for manufacturing scale-up and fill and finish at risk so that the UK has vaccines produced at scale and ready for administration should any of these prove successful
