Study Comparing the Effects of Mass Vaccine and Drug Administration on Malaria Transmission in Bangladesh

What this Trial Is About

This research aims to evaluate how mass vaccine and drug administrations impact the spread of Plasmodium falciparum malaria in villages. The study uses a cluster-randomised, open-label, controlled design with a factorial approach to compare the effects of combined mass vaccine and drug administration, mass drug administration alone, mass vaccination alone, and the current standard care. The goal is to understand if these interventions can reduce malaria parasite prevalence and transmission over time. Participants will be divided into four groups based on their village those receiving both the R21Matrix-M vaccine and antimalarial drugs at months 0, 1, 2, with a booster vaccine at month 12 those receiving only the drug regimen at months 0, 1, and 2 those receiving only the vaccine doses at months 0, 1, 2, and booster at month 12 and a control group receiving standard care during the first 24 months. After 24 months, the control group may receive the combined intervention if it is found to be safe and effective. Participants of all ages 6 months and older in the villages will be enrolled and followed for two years from the start of intervention. Researchers will collect blood samples every six months to detect malaria parasites and monitor clinical malaria incidence continuously. They will also track severe malaria cases, deaths, drug resistance, antibody levels, and intervention acceptability. Adverse events will be recorded throughout the study period to evaluate safety and effectiveness.

Mass Vaccine and Drug Administration, Bangladesh