*Study of mRNA-1273.529 (omicron variant) compared to mRNA-1273 (original) booster vaccine
Research type
Research Study
Full title
A Phase 2/3, Randomized, Observer-blind, Active-controlled, Multicenter Study to Evaluate the Immunogenicity and Safety of mRNA-1273.529 (B.1.1.529, Omicron Variant) in Comparison with mRNA-1273 (Prototype) Booster Vaccine
IRAS ID
1004941
Contact name
Ivan Lee
Contact email
Sponsor organisation
ModernaTX, Inc.
Eudract number
2022-000063-51
ISRCTN Number
ISRCTN99890480
Research summary
An outbreak of COVID-19 caused by the novel coronavirus SARS-CoV-2 has spread throughout the world. There are now a number of vaccines that have been approved to prevent COVID-19.
Vaccines serve to prepare the immune system for fighting infection and preventing illness. The immune system produces antibodies which recognise viruses and make them harmless. COVID-19 vaccines boost the immune system to produce enough antibodies against SARS-CoV-2 so in case of an infection, the virus does not cause illness. The mRNA-1273 vaccine has been approved for emergency use for prevention of COVID-19. The mRNA-1273.529 vaccine targets the omicron strain of SARS-CoV-2 and is not yet approved.
The purpose of this study is to compare the body’s immune response to a booster dose of mRNA-1273 vaccine compared to mRNA-1273.529 vaccine. Healthy people who are at least 16 years old and have already received 2 or 3 doses of an authorised or approved COVID-19 vaccine may be eligible to participate.
Participants will be randomised in a 1:1 ratio to receive either the mRNA-1273 or mRNA-1273.529 vaccine. They will remain in the study for 12 months. They will attend the clinic for visits at screening, Day 1, (Day 8), and Months 1, 3, 6 and 12. They will also have 3 or 4 safety phone calls during this time. Procedures during the visits will include physical examination, vital signs, nasopharyngeal swab, blood sampling and participants will need to complete an e-diary.
This study is sponsored by ModernaTX, Inc. Approximately 2924 patients will participate in this study in the UK.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0186
Date of REC Opinion
2 Feb 2022
REC opinion
Further Information Favourable Opinion