A Phase 2 study of CV0701 & CV0601 COVID 19 mRNA vaccines in adults
Research type
Research Study
Full title
A Phase 2 randomized, active-controlled, observer-blind study to assess the safety, reactogenicity, and immunogenicity of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults who previously received a complete primary vaccination series with or without booster dose(s)
IRAS ID
1008053
Contact name
Martin Gaudinski
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals SA
Research summary
CureVac (a biopharmaceutical company) and GSK have developed messenger ribonucleic acid (mRNA) COVID-19 vaccines called CV0601 and CV0701. These vaccines were made to reduce COVID-19 infections, including moderate or severe COVID-19. The difference between these 2 vaccines is that CV0601 is a monovalent vaccine based on the Omicron BA.4-5 strain and CV0701 is a bivalent vaccine based on both the original and Omicron BA.4-5 strains. This study will test the CV0601 and CV0701 vaccines when given as a booster.
The mRNA vaccines do not contain the virus that causes COVID-19. They do not contain the virus proteins or any other part of the virus. When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the viral surface strain proteins. The person's immune system recognises these proteins and mounts a protective response to them.
The purpose of the study is to test how the body responds to the study vaccines and if they are safe and well tolerated.
This trial is recruiting healthy participants who are 18 years or older and have completed a primary vaccination series with or without a booster vaccination of an approved or authorised COVID-19 vaccine. Participants last vaccination with an mRNA COVID-19 vaccine should be at least 3 months before joining the study.
Participants will be randomised into one of five treatment groups as follows and remain in the study for 6 months.
• CV0701 Single dose of bivalent vaccine made up of 12micrograms of each vaccine component
• CV0701 Single dose of bivalent vaccine made up of 6 micrograms of each vaccine component
• CV0701 Single dose of bivalent vaccine made up of 3 micrograms of each vaccine component
• CV0601 Single dose of monovalent vaccine made up of 12 micrograms vaccine.
• Comparator vaccine Pfizer-BioNTech (single dose 30 micrograms)REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0673
Date of REC Opinion
23 Nov 2023
REC opinion
Further Information Unfavourable Opinion