NCT04601714

Baseline Cohort Malaria Morbidity Study

Baseline Cohort Study to Assess the Malaria Morbidity in Children Living in Future Malaria Vaccine Candidate Trial Sites

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 459 (actual)
• Sponsor: Groupe de Recherche Action en Sante · Academic / Other
• Sex: All
• Age: 18 Months – 12 Years
• Healthy volunteers: —

Summary

The BLOOMy study is a longitudinal prospective cohort study of healthy children to assess the incidence of clinical malaria over the main transmission season. Participants will undergo baseline clinical and biological assessments then will receive a curative dose of either artesunate or dihydroartemisinin-piperaquine to clear any existing parasitemia. Clearance of parasites will be confirmed 3 weeks later by Polymerase chain reaction (PCR) and only participants with negative PCR will be definitively enrolled for the longitudinal follow up. Both active and passive case detection will be used to ensure that capture of a high proportion of infections in the cohort is achieved. Blood samples for immunological assessments will be obtained at Day 0 of each positive blood smear episode before treatment and at Weeks 4 post treatment. Participants will be followed for a minimum of six months throughout the malaria peak transmission season.

Detailed description

The BLOOMy study has two co-Primary objectives: * To assess the incidence of clinical malaria meeting the primary case definition in children aged 1.5 to 12 years living in the study area over the main transmission season * To assess the occurrence of reinfection following the radical cure of existing parasitemia. The secondary objectives are: * To assess the incidence of clinical malaria meeting various secondary cases definition in children aged 1.5 to 12 years living in the study area over the main transmission season * To measure the immune responses (humoral and cell-mediated) to a panel of malaria vaccine candidate antigens * To assess the molecular force of infection * To pilot and standardize malaria morbidity assessment in three phase 2 malaria vaccine testing sites.

Conditions

• Malaria

Timeline

• Start date: 2020-09-07
• Primary completion: 2021-09-28
• Completion: 2021-12-31
• First posted: 2020-10-26
• Last updated: 2023-02-24

Locations

1 site across 1 country: Burkina Faso