Mass Vaccine and Drug Administration, Bangladesh (MVDA)

University of Oxford

Status and phase: Enrolling; Phase 4

Conditions: Plasmodium Falciparum Malaria

Treatments: Drug: DHA/piperaquine and a SLD-PQ; Biological: Study vaccine R21/Matrix-M™

Study type: Interventional

Funder types: Other

Identifiers

NCT06068530

MAL23002

Details and patient eligibility

About

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.

Full 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?

Enrollment: 10,000 estimated patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10,000 participants in 4 patient groups

MDA + Vaccine

Active Comparator group

Description:

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

Treatment:

Biological: Study vaccine R21/Matrix-M™

Drug: DHA/piperaquine and a SLD-PQ

MDA only

Active Comparator group

Description:

The participants in MDA only villages will receive DHA/piperaquine and a SLD-PQ at M0, M1, and M2

Treatment:

Drug: DHA/piperaquine and a SLD-PQ

Vaccine only

Active Comparator group

Description:

The participants in vaccine only villages will receive R21/Matrix M at M0, M1, M2, and a booster M12

Treatment:

Biological: Study vaccine R21/Matrix-M™

Control

No Intervention group

Description:

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.