Mass vaccination and drug administration for malaria in Bangladesh
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
This study is testing if giving a malaria vaccine and medication to whole villages in Bangladesh can reduce the spread of malaria compared to villages that don’t receive them.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10000 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 2 sites (Bāndarban and 1 other locations) |
| Trial ID | NCT06068530 on ClinicalTrials.gov |
What this trial studies
This open, cluster-randomised, controlled intervention aims to evaluate the effectiveness of mass drug administrations and vaccinations against Plasmodium falciparum malaria. The study will enroll entire village populations and follow them for two years to compare malaria transmission rates between intervention and control villages. It will also assess the individual effectiveness of the vaccine and drug treatments. Participants will receive the DHA/piperaquine treatment and the R21/Matrix-M™ vaccine as part of the intervention.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 6 months and older residing in the study villages.
Not a fit: Patients who are pregnant, planning to become pregnant, or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce malaria transmission and improve public health outcomes in affected regions.
How similar studies have performed: Previous studies have shown promise in using mass drug and vaccine administration to combat malaria, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bāndarban and 1 other locations
- Alikadam Upazila Health Complex — Bāndarban, Bangladesh (Recruiting)
- Lama Upazila Health Complex — Lāma, Bangladesh (Recruiting)
Study contacts
- Principal investigator: Lorenz von Seidlein — Mahidol University
- Study coordinator: Lorenz von Seidlein
- Email: Lorenz@tropmedres.ac
- Phone: +66926486322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.