A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥ 60 Years of Age
Study Period: July 2022 – June 2025
Sample Size: 1750Doner Name: Moderna TX.
Project Description:
Background: Pneumonia and other lower respiratory tract infections account for a sizable portion of the sickness burden in older people. In 195 countries, it is projected that lower respiratory infections contributed to 1.27 million deaths among older people in 2015. Acute respiratory disease (ARD) in older persons has been linked to respiratory syncytial virus (RSV), which is also increasingly recognized as a significant cause of illness in adults with certain comorbidities (or "high-risk"), such as those with chronic lung and heart disease.A phase 3 FDA regulated trial sponsored by Moderna TX, Inc in more than 250 sites of countries including Bangladesh, Europe, Asia, Africa and America. Projahnmo Research Foundation (PRF) and Johns Hopkins Bloomberg School of Public Health (JHSPH) are jointly conducting the trial in two sites in Sylhet, Bangladesh.
Objective: The primary objective of the trial is to evaluate the safety and tolerability of the mRNA-1345 vaccine and to evaluate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo within the period of 14 days post injection up to 12 months post injection.
Method: Participants will be adults older than 60 years, and 20% will be older than 75 years. The study phase is comprised of vaccination [Day 1 to Day 29 (28 days following the first injection)] and surveillance phase [Day 15 through Month 24]. There will be a screening period (up to 14 days prior to research injection), a single study injection (Day 1), and a follow-up period for each phase of the study (up to 24 months after study injection). Each participant will spend roughly 25 months in the trial. The research site will be visited by each participant up to seven times as scheduled, including on Day 1, Day 15, Day 29, Day 181, Day 365, Day 546, and Day 730. The enrolled participants will be under weekly active surveillance using e-diary fill up of any respiratory illness symptoms.