Com-COV: Comparing COVID-19 Vaccine Schedule Combinations
A single-blind, randomised, phase II adaptive platform UK multi-centre study to determine reactogenicity and immunogenicity of heterologous prime/boost COVID-19 vaccine schedules (Com-COV)
Funder: Department for Business, Energy and Industrial Strategy
Sponsor: University of Oxford
CI: Professor Matthew Snape
Approval Date: 13 January 2021
On the 2nd December 2020 the MHRA granted emergency authorisation for a vaccine against COVID-19, 'COVID-19 mRNA Vaccine BNT162b2', the European Medicines Agency then granted conditional authorisation on 21st December 2020. This was followed by emergency authorisation of the Oxford/AstraZeneca ChAdOx1 nCOV-19 vaccine on the 29th December 2020 by the UK MHRA. Both of these vaccines are approved for use as homologous two-dose regimens. There are likely to be significant logistical challenges immunising large portions of the population. There would be significant advantages to having flexible immunisation programmes whereby the second vaccine dose is not necessarily the same as the first dose. Accordingly, this study will determine the safety as well as the immune responses to a variety of combinations of prime/boost schedules for candidate COVID-19 vaccines that are potentially to be deployed in the UK. The vaccines to be studied in this protocol will primarily be determined by those made available to the Department of Health and Social Care (DHSC) for population use. Furthermore, given the UK introduction of COVID-19 vaccines has utilised an extended (up to 12 week) interval between the first and second dose of vaccine, this study will evaluate combinations of vaccines with a 12 week, as well as 4 week, dosing interval.
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