Baseline Cohort Malaria Morbidity Study (BLOOMy)
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|ClinicalTrials.gov Identifier: NCT04601714|
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : July 29, 2021
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||464 participants|
|Official Title:||Baseline Cohort Study to Assess the Malaria Morbidity in Children Living in Future Malaria Vaccine Candidate Trial Sites|
|Actual Study Start Date :||September 7, 2020|
|Estimated Primary Completion Date :||September 28, 2021|
|Estimated Study Completion Date :||December 31, 2021|
- Number of clinical malaria episodes per child-year at risk meeting the primary case definition [ Time Frame: 6 months ]The primary case definition: Positive P. falciparum parasitemia at a density > 0 detected by microscopy associated with measured fever (Axillary temperature ≥37.5°C/Tympanic ≥38°C or Forehead temperature ≥37.5°C using non-contact infrared thermometer))
- Time to P. falciparum infection detected by positive thick blood smear within 6 months after the enrolment in African children under natural exposure to P. falciparum by treatment group [ Time Frame: 6 months ]
- Number of clinical malaria episodes per child-year at risk meeting the following secondary cases definition [ Time Frame: 6 months ]Second Secondary case definition: Measured fever (Axillary temperature ≥37.5°C/Tympanic ≥38°C or Forehead temperature ≥37.5°C using non-contact infrared thermometer) AND parasitemia of >5,000 parasites (p) / μl
- Number of new P. falciparum clones acquired over time [ Time Frame: 6 months ]
- Immune responses to malaria candidate vaccines in the consortium portfolio [ Time Frame: 6 months ]Panel of malaria vaccine candidate's antigens such as PfSPZ CVAC, ME-TRAP, R21 (Pre erythrocytic stage antigens) and PfRH5, NPC-SE36 (Blood stage antigens) will be used to assess antibody responses at day 0 and 28 of confirmed episodes of clinical malaria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601714
|Contact: Alfred Tiono, MD, PhD||+226 firstname.lastname@example.org|
|Contact: Alphonse Ouedraogo, MD, PhD||+226 email@example.com|