Study of Measles and BCG Vaccines Given to Women of Fertile Age and Their Children Evaluating Effects on Immunity and Health Outcomes in Guinea-Bissau

What this Trial Is About

Researchers are investigating the effects of measles vaccine MV and Bacille Calmette-Gurin vaccine BCG given to women of fertile age before pregnancy, and the impact of providing early measles vaccination to their children. The study aims to understand both measles-specific and general immune benefits in mothers and children, focusing on antibody responses, viral loads after yellow fever vaccination, and overall health outcomes. This is a phase 4 randomized, triple-blind trial conducted in Guinea-Bissau, exploring the novel concept that vaccinating mothers with live vaccines may enhance protection for their children. In this trial, 2400 non-pregnant, HIV-negative women aged 15 to 35 will be randomly assigned to receive either the measles vaccine, BCG vaccine, or a saline placebo. Their children, all receiving BCG at birth as per local recommendations, will be further randomized at 20 weeks of age to receive either an early measles vaccine or placebo. All children will then receive the standard measles and yellow fever vaccines at 9 months. The study will create six groups combining maternal and child vaccination schedules to compare outcomes. Participants will be followed through regular home visits and health center monitoring. Women will have blood samples taken before and after vaccination to measure antibody levels. Children will be closely monitored monthly and have blood samples taken at specified ages to assess immune responses and viral loads. The study tracks morbidity and mortality data for both mothers and children over time, using interviews, hospital records, and vaccination documentation. The trial will continue until 2027, assessing which vaccination schedules best support health and immunity.

Measles and BCG Vaccines for Mother and Child