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RECRUITINGPhase 4INTERVENTIONAL

Mass Vaccine and Drug Administration, 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Current residence in a study village irrespective of permanence - Age 6 months and above (no upper age limit) - Written willing to sign a consent form provided by participants (or a parent/guardian in case the participant is under 18 years old) Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

DHA/piperaquine and a SLD-PQ

Participants in Arms 1 and 2 will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1, and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin/piperaquine on Day 0, 1, and 2 (i.e. the day of vaccination and each day for 2 days after). The drug dose is based on the weight of the participant at the first visit (M0D0). Dihydroartemisinin/piperaquine tablets (Shanghai Fosun Pharmaceutical Co., Ltd.) for adult participants each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg/kg/day dihydroartemisinin and 16-26 mg/kg/dose piperaquine. In addition, each participant will receive a single low dose primaquine on the day of vaccination (Day 0; Table 4). One single low dose primaquine of approximately 0.25 mg/kg (Thai Government Pharmaceutical Organisation) will be administered. Children under 10kg do not receive PQ.

BIOLOGICAL

Study vaccine R21/Matrix-M™

The mixing prior to administration strategy will involve withdrawal of 0.5 mL antigen from one vial of R21 Malaria vaccine and adding it to Matrix-M1 vial. 0.5 mL of R21 antigen shall be withdrawn from another vial of R21 Malaria vaccine and be added to the same Matrix-M1 vial. The total volume in Matrix-M1 vial will be 1.5 mL. After addition the content will be mixed gently, and 0.75 mL of the mixture will be withdrawn and administered to participants. Each dose of 0.75mL (after mixing of R21 with Matrix-M1) will contain 10 µg of R21 and 50 µg for participants 14 years and older. In children up to 14 years a 5 μg will be used.

Locations (2)

Alikadam Upazila Health Complex
Bāndarban, Bangladesh
Lama Upazila Health Complex
Lāma, Bangladesh