mPower
Research type
Research Study
Full title
A Randomised, Placebo-controlled, Dose-ranging, Observer-blind Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of mRNA 1769 in Healthy Participants
IRAS ID
1007297
Contact name
Brett Leav
Contact email
Sponsor organisation
ModernaTX, Inc.
Research summary
The purpose of this study is to develop a new vaccine that may prevent Mpox (monkeypox) and smallpox. This is important because a Mpox outbreak continues to persist across Europe and other regions with a limited supply of authorised vaccine.
This study will test the investigational vaccine mRNA 1769 and compare it to a placebo. A placebo looks like mRNA 1769 but has no active drug. The main goals are to test how safe and how well tolerated mRNA 1769 is in healthy adults after 1 or 2 doses, and to test the body’s immune response (how the body recognises and defends itself) against Mpox and smallpox in healthy adults.
The study has 4 dose groups (3 for mRNA 1769 and 1 for placebo). Participants will be assigned to one of the groups and receive either mRNA 1769 (at one of 3 dose levels) or placebo as an injection in the upper arm muscle twice; once on Day 1/Month 0 and once on Day 29/Month 1. Participants are assigned to these groups by chance (like a flip of a coin or drawing straws); this process is called randomisation. A computer is used to randomly place participants into the different groups. Participants will not be able to choose the treatment group to which they will be assigned. Participants have a 6 in 7 chance of receiving mRNA-1769 and a 1 in 7 chance of receiving placebo.
Participants will be in the study for about 13 to 14 months. This includes about 9 study site visits and 3 scheduled phone visits. Participants may also be asked to come to the study site if they experience a possible side effect or reaction.
The study Sponsor is ModernaTX, Inc. This study will include approximately 350 participants in total from the UK.REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0463
Date of REC Opinion
17 Jul 2023
REC opinion
Further Information Favourable Opinion