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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Bangladesh
Alikadam Upazila Health Complex
RECRUITING
Bāndarban
Lama Upazila Health Complex
RECRUITING
Lāma
Contact Information
Primary
Lorenz von Seidlein
Lorenz@tropmedres.ac
+66926486322
Backup
Rupam Tripura
Rupam@tropmedres.ac
+8801572288558
Time Frame
Start Date: 2025-02-15
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 10000
Treatments
Active_comparator: MDA + Vaccine
The participants in MVDA villages will receive R21/Matrix M at M0, M1, M2, and a booster M12 plus DHA/piperaquine and a SLD-PQ at M0, M1, and M2
Active_comparator: MDA only
The participants in MDA only villages will receive DHA/piperaquine and a SLD-PQ at M0, M1, and M2
Active_comparator: Vaccine only
The participants in vaccine only villages will receive R21/Matrix M at M0, M1, M2, and a booster M12
No_intervention: Control
The participants in control will receive MVDA at the end of the 24th month assuming that MVDA is found to be safe and effective. During M0 to M24, the comparison villages will receive the standard of care as per national malaria treatment guidelines.
Related Therapeutic Areas
Sponsors
Leads: University of Oxford