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Trial record 2 of 4 for:    PfRH5

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
Sponsor:
Information provided by (Responsible Party):
Sodiomon B.Sirima, Groupe de Recherche Action en Sante

Tracking Information
First Submitted Date October 20, 2020
First Posted Date October 26, 2020
Last Update Posted Date July 29, 2021
Actual Study Start Date September 7, 2020
Estimated Primary Completion Date September 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 20, 2020)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 30, 2020)
  • 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.
Original Secondary Outcome Measures
 (submitted: October 20, 2020)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Baseline Cohort Malaria Morbidity Study
Official Title Baseline Cohort Study to Assess the Malaria Morbidity in Children Living in Future Malaria Vaccine Candidate Trial Sites
Brief 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Healthy children aged 1.5 to 12 years
Condition Malaria
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 28, 2021)
464
Original Estimated Enrollment
 (submitted: October 20, 2020)
455
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date September 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Healthy children aged 1.5 to 12 years
  • Residence in the study area or surroundings for the period of the study
  • Written informed consent from parents/legally acceptable representatives and an assent for children

Exclusion Criteria:

  • Complicated symptomatic malaria (defined according to standard World Health Organization criteria)
  • Anaemia (Hb<8g/dL),
  • Any (chronic) illness that requires immediate clinical care.
  • Family history of sudden death or of congenital or clinical conditions known to prolong QTcB or QTcF interval or e.g. family history of symptomatic cardiac arrhythmias, with clinically relevant bradycardia or severe cardiac disease
  • Any treatment which can induce a lengthening of QT interval
  • Known history of hypersensitivity or allergic reactions to piperaquine or other aminoquinolones
  • Receipt of any blood transfusion or immunoglobulins within 3 months
  • Known history of hypersensitivity or allergic reactions to artesunate
  • Severe malnutrition (weight-for-height being below -3 standard deviation or less than 70% of median of the World Health Organization (WHO) normalized reference values).
  • Weight below 5 kg
  • Current or previous participation in malaria vaccine trials
  • Current active participation in any trial involving administration of investigational drug.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Months to 12 Years   (Child)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Alfred Tiono, MD, PhD +226 70285726 a.tiono@gras.bf
Contact: Alphonse Ouedraogo, MD, PhD +226 70140811 a.ouedraogo@gras.bf
Listed Location Countries Burkina Faso
Removed Location Countries  
 
Administrative Information
NCT Number NCT04601714
Other Study ID Numbers Protocol_BLOOMy study
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Sodiomon B.Sirima, Groupe de Recherche Action en Sante
Study Sponsor Groupe de Recherche Action en Sante
Collaborators Not Provided
Investigators Not Provided
PRS Account Groupe de Recherche Action en Sante
Verification Date July 2021