Mass Vaccine and Drug Administration, Bangladesh

Trial Activities: The investigators are most interested in the combined effect of mass administration of vaccines and drugs on malaria transmission. Can Mass Vaccine and Drug Administrations (MVDA) reduce the parasite prevalence in intervention villages compared to control villages which did not receive the intervention? The entire village population will be enrolled at study start and followed for two years after D0, the first day of the interventions in the intervention villages. The village population is a dynamic cohort with new members entering the cohort by birth or immigration and other members leaving the cohort due to emigration or death. Newcomers entering villages will receive MVDA as soon as feasible and as appropriate (dependent on age). Secondly, the investigators want to know how effective the individual components of the intervention, mass vaccinations and mass drug administrations are in relation to MVDA?

Hanako Foundation funded this study. Grant reference number: B9R05700

• The incidence of Deaths related to falciparum malaria among study groups [Time frame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)]
• The incidence of severe malaria disease among study groups [Time frame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)]
• The incidence of severe anaemia among study groups [Time frame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)]
• Vivax malaria incidence by study groups [Time frame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)]
• Vivax malaria prevalence by study groups [Time frame: PCR for malaria detection from DBS will be collected at 6th month intervals until two years following baseline intervention (Month 0, Month 6, Month 12, Month 18 and Month 24)]
• Overall percentage of vivax malaria positivity by study groups [Time frame: DBS: Month 0, Month 6, Month 12, Month 18 and Month 24 and Clinical malaria data for two year following intervention]
• The incidence of adverse events [Time frame: All adverse events which occur after administration of the first dose of the study drugs until one month after last dose of drugs or vaccine will be recorded. This data will be collected from Month 0 to month 24.]
• The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody) among subset of randomly selected participants from vaccinated and no intervention group. [Time frame: One month after the completion of the third dose (at Study month 3), and one month after the booster dose (at Study Month 13)]
• Prevalence of molecular markers for drug resistant P. falciparum [Time frame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)]
• The acceptability of the intervention will be assessed by coverage (The number of residents participating in the interventions) reported as percentage of the target population participating in the intervention. [Time frame: Month 3 and Month 13]
• The acceptability of the intervention will be assessed by mixed social science methods, in depth interviews and Focus group discussions. [Time frame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)]
• The incidence of clinical falciparum malaria confirmed by RDT or microscopy among vaccinated and drug administered participants in compare to unvaccinated and no drug-administered participants living in standard-of-care villages. [Time frame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)]