Com-COV vaccine mix-and-match study expands to 12-to-16-year-olds
17 September 2021
- Com-COV 3 to test multiple options for second dose COVID-19 vaccines in young people aged 12 to 16 years
- Participants immunised with first dose of Pfizer-BioNtech to receive either second full dose Pfizer-BioNtech, half dose Pfizer-BioNtech, half dose Moderna or full dose Novavax – eight-week interval
- Researchers to assess reactogenicity and immunogenicity of vaccine schedules
Researchers running the University of Oxford-led Com-COV programme have launched a new study of COVID-19 vaccination schedules in young people aged 12 to 16.
Backed through funding from the Vaccines Taskforce and National Institute for Health Research (NIHR) and run across four NIHR-supported sites by the National Immunisation Schedule Evaluation Consortium, the Com-COV 3 trial will seek to recruit 360 volunteers.
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.’
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.
Professor Matthew Snape said: ‘This is the latest in series of studies such as COMCOV 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.’
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: ‘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.’
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.
All those who are interested can register via the study website comcovstudy.org.uk
A brief Com-COV timeline
The University of Oxford is leading the Com-COV 3 study, run by the National Immunisation Schedule Evaluation Consortium (NISEC) and backed by £2.8 million of government funding from the Vaccines Taskforce.
In May, researchers reported preliminary Com-COV data revealing more frequent mild to moderate reactions in mixed schedules compared to standard schedules, however, these were short-lived in duration. In June, they further reported that ‘mixed’ schedules involving Pfizer-BioNTech and Oxford-AstraZeneca induced high concentrations of antibodies against the SARS-CoV2 spike IgG protein when doses were administered four weeks apart.
In April, the researchers expanded the programme to include the Moderna and Novavax vaccines in a new study.
Notes to Editors:
For an interview with the lead researchers from the University of Oxford, please contact: firstname.lastname@example.org
For interviews with the lead investigators from the four sites below, please contact the NIHR Press Office (email@example.com), who can support your request.
About the Com-COV 3 trial:
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 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 National Institute for Health Research
The National Institute for Health Research (NIHR) is the nation's largest funder of health and care research. The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR commissions applied health research to benefit the poorest people in low- and middle-income countries, using Official Development Assistance funding.
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
About the University of Oxford
Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the sixth year running, and at the heart of this success is our ground-breaking research and innovation.
Oxford is world-famous for research excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research sparks imaginative and inventive insights and solutions.
Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988. Over a third of these companies have been created in the past three years.