Earlier prime-boost schedule to improve measles protection in high burden settings (BoostME)
Study design
Phase IIb, Randomised controlled trial, open label
Context
Measles remains a major cause of childhood morbidity and mortality in sub-Saharan Africa despite existing vaccination programs. Infants under 9 months continue to experience a high risk of infection due to waning maternal immunity and delayed eligibility for routine vaccination. Findings from this study will provide evidence on the effectiveness and timing of early measles vaccination in Uganda and similar high-burden settings. The results may inform national and global immunization policies aimed at improving protection among vulnerable infants, reducing breakthrough infections, and strengthening measles control and elimination efforts
The purpose of this study is to evaluate the immunological and clinical effectiveness of early measles vaccination among children in a high measles transmission setting in Uganda. Specifically, the study seeks to compare protective measles antibody responses and clinical protection among children receiving an early measles-containing vaccine (MCV1) schedule at 6 and 12 months versus the standard vaccination schedule at 9 and 18 months.
Objectives
Primary objective
- To compare the proportion of infants with measles infections in those receiving 2 doses of MR vaccine at 6 and 12 months of age with 2 doses at 9 and 18 months of age
Secondary objectives
- To compare the proportion of rubella infections in infants receiving 2 doses of the MR vaccine at 6 and 12 months of age with 2 doses at 9 and 18 months of age
- To compare the antibody response to a first dose of the MR vaccine in those who become infected, with the antibody response from uninfected participants in Part 1
To assess the safety of the vaccine when given at different ages
Our role
- Site d'étude : Centre de Mbarara
Sponsor
- University of Oxford
Partners
- CNPI
- MU-JHU care
Funder
- Gates Foundation