Clinical trial NCT06068530: Mass Vaccine and Drug Administration, Bangladesh
Official title: A Cluster-randomised, Open-label Trial to Compare the Impact of Combined Mass Vaccine and Drug Administrations, Mass Drug Administration, Mass Vaccinations, or no Intervention on Plasmodium Falciparum Malaria Transmission
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Plasmodium Falciparum Malaria
Keywords: Plasmodium Falciparum Malaria
Malaria Vaccine
Malaria Drug Administrations
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2023-10-05
Enrollment: 10000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an open i.e. not blinded, cluster-randomised, controlled intervention study. The study will use a factorial design to estimate the protective effectiveness of mass drug administrations, mass vaccinations, combined mass vaccinations and drug administrations versus the current standard of care.

Detailed description: Trial Activities: The investigators are most interested in the combined effect of mass administration of vaccines and drugs on malaria transmission. Can 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?

Eligibility criteria: Inclusion Criteria:

* Current residence in a study village irrespective of permanence
* Age 6 months and above (no upper age limit)
* Written informed consent provided by participants (or a parent/guardian in case the participant is under 18 years old)

Exclusion Criteria:

* Pregnancy, plan to get pregnant, or breastfeeding.
* Acute illness requiring intervention
* A history of an adverse reaction to study drugs/vaccine and prior receipt of any other malaria vaccine or enrolment in another intervention trial.

Primary outcomes:
measure: Falciparum malaria incidence by study groups
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: Falciparum malaria prevalence by study groups
timeFrame: 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)
measure: Overall percentage of falciparum malaria positivity by study groups
timeFrame: DBS: Month 0, Month 6, Month 12, Month 18 and Month 24 and Clinical malaria data for two year following intervention
Secondary outcomes:
measure: The incidence of Deaths related to falciparum malaria among study groups
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: The incidence of severe malaria disease among study groups
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: The incidence of severe anaemia among study groups
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: Vivax malaria incidence by study groups
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: Vivax malaria prevalence by study groups
timeFrame: 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)
measure: Overall percentage of vivax malaria positivity by study groups
timeFrame: DBS: Month 0, Month 6, Month 12, Month 18 and Month 24 and Clinical malaria data for two year following intervention
measure: The incidence of adverse events
timeFrame: 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.
measure: 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.
timeFrame: One month after the completion of the third dose (at Study month 3), and one month after the booster dose (at Study Month 13)
measure: Prevalence of molecular markers for drug resistant P. falciparum
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: 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.
timeFrame: Month 3 and Month 13
measure: The acceptability of the intervention will be assessed by mixed social science methods, in depth interviews and Focus group discussions.
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: 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.
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: The incidence of clinical falciparum malaria confirmed by RDT or microscopy among vaccinated participants in compare to unvaccinated participants living in standard-of-care villages.
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: The incidence of clinical falciparum malaria confirmed by RDT or microscopy among drug administered participants in compare to no drug-administered participants living in standard-of-care villages.
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: The incidence of clinical falciparum malaria confirmed by RDT or microscopy among unvaccinated and no drug-administered people living in intervention clusters relative to unvaccinated and no drug-administered people living in standard-of-care villages.
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: The incidence of clinical falciparum malaria confirmed by RDT or microscopy among unvaccinated people living in intervention clusters relative to unvaccinated people living in standard-of-care villages.
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
measure: The incidence of clinical falciparum malaria confirmed by RDT or microscopy among no drug-administered people living in intervention clusters relative to no drug-administered people living in standard-of-care villages.
timeFrame: Data will be collected for two years following baseline intervention (Month 0 to Month 24)
Other outcomes:
Locations:
city: Bāndarban
country: Bangladesh
facility: Alikadam Upazila Health Complex
city: Lama
country: Bangladesh
facility: Lama Upazila Health Complex
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
name: Lorenz von Seidlein
role: PRINCIPAL_INVESTIGATOR
References: