Perennial Malaria Chemoprevention in the Malaria Vaccine Era (PMC-VAC)

Stanford University

Status and phase: Begins enrollment in 6 months; Phase 4

Conditions: Malaria, Falciparum

Treatments: Drug: Dihydroartemisinin Piperaquine; Drug: Sulfadoxine pyrimethamine + Amodiaquine placebo; Drug: Dihydroartemisinin Piperaquine Placebo; Drug: Sulfadoxine pyrimethamine + Amodiaquine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07322068

84540

Details and patient eligibility

About

Malaria remains a major cause of pediatric deaths and morbidity in Africa. An affordable malaria vaccine, R21, is being deployed in Uganda and other African countries with high malaria transmission, but efficacy is incomplete and wanes rapidly, and R21 does not provide protection until infants complete the primary vaccination series, or ~9 months of age. The goal of this study is to see whether combining R21 vaccination with two novel perennial malaria chemoprevention regimens can enhance protection against malaria compared with R21 alone. This study will take place at Masafu General Hospital (MGH) in Busia District, a rural area in Southeastern Uganda bordering Lake Victoria.

Enrollment: 1,290 estimated patients

Sex: All

Ages: 1 day to 10 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Residency in Busia District, Uganda
• Provision of informed consent by the parent/guardian for her child
• Agreement to come to the study clinic for any febrile episode or other illness and avoid, where possible, medications given outside the study protocol

Exclusion criteria

• Intention of permanently moving outside Busia district during the study period
• Active medical problem requiring inpatient evaluation or chronic medical condition requiring frequent medical attention at the time of screening
• Evidence of sickle cell disease (Hemoglobin SS genotype)
• Biological mother known to be HIV positive

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,290 participants in 3 patient groups, including a placebo group

PMC-Placebo

Placebo Comparator group

Description:

Placebo given at Expanded Program of Immunization (EPI) visits (8 doses of placebo at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age). Participants will receive DP placebo plus SPAQ placebo. Placebos with an identical appearance to either DP or SPAQ active drugs will be provided by their manufacturers.

Treatment:

Drug: Dihydroartemisinin Piperaquine Placebo

Drug: Sulfadoxine pyrimethamine + Amodiaquine placebo

PMC-SPAQ

Experimental group

Description:

Perennial malaria chemoprevention with sulfadoxine-pyrimethamine + amodiaquine (SPAQ) given at Expanded Program of Immunization (EPI) visits (8 doses of SPAQ at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age). Participants will also receive DP placebo along with active SPAQ. Placebo with an identical appearance to DP active drug will be provided by its manufacturer.

Treatment:

Drug: Sulfadoxine pyrimethamine + Amodiaquine

Drug: Dihydroartemisinin Piperaquine Placebo

PMC-DP

Experimental group

Description:

Perennial malaria chemoprevention with dihydroartemisinin-piperaquine (DP) given at Expanded Program of Immunization (EPI) visits (8 doses of DP at 2.5, 3.5, 6, 7, 8, 9, 12, and 18 months of age). Participants will also receive SPAQ placebo along with active DP. Placebo with an identical appearance to SPAQ active drug will be provided by its manufacturer.

Treatment:

Drug: Sulfadoxine pyrimethamine + Amodiaquine placebo

Drug: Dihydroartemisinin Piperaquine