Human challenge study to evaluate the efficacy of MV-012-968 vaccine
Research type
Research Study
Full title
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Prophylactic Efficacy of MV-012-968 Against Respiratory Syncytial Virus (RSV) Infection in the Virus Challenge Model.
IRAS ID
285759
Contact name
Mariya Kalinova
Contact email
Sponsor organisation
Meissa Vaccines Inc.
Eudract number
2020-002848-22
Duration of Study in the UK
0 years, 7 months, 29 days
Research summary
RSV infection can cause a range of respiratory disease such as bronchitis and lower respiratory infections including bronchiolitis and pneumonia. These serious illnesses affect infants, certain adults who are older (especially if they are ≥65), have chronic heart or lung disease or have weakened immune system.
The only approved treatment for RSV is a drug called ribavirin but because of its unwanted side effects, and low effectiveness (performance), it is rarely used. There are vaccines in development for the prevention of RSV, however there is no vaccine against RSV currently approved for use.
The purpose of this research study is to test the effects of an experimental vaccine called MV-012-968 (the ‘study vaccine’) and whether it may be useful in preventing the infection of Respiratory Syncytial Virus (RSV).
This is a randomised, placebo-controlled, double-blind Phase 2a human challenge study, to be conducted in approximately 60 healthy male and female participants aged 18-45 years inclusive, who have been pre-screened to have low immunogenicity to the RSV virus and for susceptibility to RSV infection.
Approximately 60 (up to 70) participants will be vaccinated to account for withdrawals between vaccination and challenge. Participants will be randomised 1:1 to receive vaccine or placebo.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0279
Date of REC Opinion
3 Dec 2020
REC opinion
Further Information Favourable Opinion