D5290C00005 MEDLEY, MEDI8897 for RSV in high risk children
Research type
Research Study
Full title
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
IRAS ID
269256
Contact name
Saul Faust
Contact email
Sponsor organisation
MedImmune, LLC
Eudract number
2019-000201-69
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
118524, IND
Duration of Study in the UK
2 years, 7 months, 17 days
Research summary
The purpose of this study is to evaluate how effective a drug called MEDI8897 (an antibody product, similar to a vaccine) is at preventing lung disease caused by Respiratory Syncytial Virus (RSV) and to evaluate the safety and tolerability of MEDI8897 in high risk infants compared with the currently approved product Synagis®.
MEDI8897 it is a type of antibody called a monoclonal antibody (an antibody produced by a single clone of cells or cell line and consisting of identical antibody molecules) that is made in the laboratory and acts against RSV. MEDI8897 is designed to extend the time the antibody is active in the body against RSV. It is expected that MEDI8897 can be given once to provide protection against RSV for the entire 5 months of the RSV season. A medicine like MEDI8897 that requires fewer doses could be used to prevent RSV in all infants.
The overall research study is planned to go on for up to 3 years and include around 1500 patients who are currently eligible to receive Synagis®. Sites in approximately 32 countries will participate in the study, and each child is expected to participate for 12 months or for 24 months if he/she has Chronic Lung disease (CLD) or Congenital Heart Disease (CHD). This could be longer if the child has CHD and requires a replacement dose of study drug (MEDI8897 or Synagis®).
The study will be run in two cohorts, over two RSV seasons. For season 1, for preterm infants, the study consists of a Screening period (up to 30 days), a Treatment period (5 months) and a Follow-Up period, including phone calls (7 months). For season 2, participants with CLD or CHD will repeat the Treatment and Follow-Up periods for another year.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0416
Date of REC Opinion
4 Sep 2019
REC opinion
Favourable Opinion