A randomized, observer-blind, active-controlled Phase 3 study to investigate the safety and immunogenicity and relative vaccine efficacy of mRNA-1283.222 administered as a booster dose compared with mRNA1273.222 in participants aged 12 years and older for the prevention of COVID-19 (NextCOVE)

Status: Closed to recruitment 

Population: Adult (18+) and Paediatric (12-18yo) 

Disease group: COVID-19 

Funder and Sponsor: ModernaTX, Inc 

Chief Investigator: Dr Catherine Cosgrove 

Study Aims

The purpose of this clinical research study is to develop a new vaccine for coronavirus disease (COVID- 19). mRNA-1283.222 is a vaccine being studied in this clinical research study. 

ModernaTX, Inc. is using the same technology as the previously approved and authorised mRNA COVID- 19 vaccines, to develop additional SARS-CoV-2 mRNA vaccines that may be as protective as the currently authorised vaccine but at a lower dose level. It is likely that this study vaccine may also be more stable for a longer period stored at refrigerated temperatures than the mRNA-1273.222 vaccine.  

This study will investigate if mRNA-1283.222 when given as a booster dose in participants aged 12 years and older is safe and effective in prevention of COVID-19, when compared to the authorised vaccine, SPIKEVAX (mRNA- 1273.222). 

What does participating in the study involve? 

If you take part in this study, you will: 

  • Have visits to the study site that may include questions about your health, physical examinations, blood tests, nasal swab collection and other medical tests 
  • Be asked to complete an electronic study diary 
  • Receive the study vaccine 
  • Be randomly assigned to receive one of these study vaccines: 
    • mRNA-1283.222: The new vaccine, being tested. 
    • mRNA-1273.222: A vaccine currently authorised to prevent COVID-19. 

 You will be in the study for approximately 12 months. This includes at least 5 study visits (where you come to the study site) and 3 visits by phone as well as possible unscheduled visits, if needed. 

Contact email/study website: NextCOVEStudyUK.com / nextcovestudy@sgul.ac.uk.