Impact of Seasonal Malaria Chemoprevention on Immunity Against Malaria Among Children in Northern Benin

NCT05650502 | Completed FDA Drug

• 1 other identifier: University of Parakou
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of SMC (Seasonal malaria chemoprevention) with Sulfadoxine-Pyrimethamine (SP) and Amodiaquine (AQ) on the evolution of anti-malarial immunity of children and their susceptibility to malarial infection. This is a cross-sectional study on children aged 6 to 59 months with/without SMC in two villages in northern Benin. Sociodemographic and clinical data as well as repeated blood samples will be collected from 440 children (before, during and after treatment). Samples will be analyzed using a Luminex assay to investigate antibody responses to MSP (merozoite surface protein) , Glurp (Glutamate-Rich Protein) and a panel of PfEMP1. qPCR (quantitative polymerase chain reaction) will be used to detect the prevalence of malaria at this period and parasites infecting children will be characterize during the follow up.

Conditions

Plasmodium Malariae Infection; SMC; Immune System Disease

Keywords

Seasonal malaria chemoprevention; Malaria; Children; Anti PfEMP1

Outcome Measures

Primary Outcomes (1)

• Efficiency of Seasonal malaria chemoprevention

  Malaria prevalence during the intervention

  January 2023

Secondary Outcomes (1)

• Impact of Seasonal malaria chemoprevention

  June 2023

Study Arms (2)

ISC (ISAMIMA children group-Cobly)

This group included children from 6 to 59 months living in Cobly and receiving the SMC treatment. The treatment is administered for three consecutives days for 4 months (from july to october). For children under 12 months: one dose of SP 250/12.5mg on day 1 AQ 75mg once daily for 3 days For children from 12 to 59 months: one dose of SP 500/25mg on day 1 AQ 150 mg once daily for 3 days A monthly visit was planned for monitoring during the follow up. Sample was collected in jun, september, january and April.

Drug: saisonal malaria chimoprevention

IST (ISAMIMA children group-Tchaourou)

This group included children from 6 to 59 months living inTchaourou and who did not receiving the SMC treatment. A monthly visit was planned for monitoring during the follow up. Sample was collected in jun, september, january and April.

Drug: saisonal malaria chimoprevention

Interventions

saisonal malaria chimoprevention DRUG

Investigate the impact of saisonal malaria chimoprevention on children anti PfEMP1 construction and maintenance and their succeptibility to malaria infection

ISC (ISAMIMA children group-Cobly); IST (ISAMIMA children group-Tchaourou)

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children who meet the inclusion and exclusion criteria, living in the communes of Cobly and Tchaourou located in northern Benin, whether or not they have received Saisonal malaria chimotreatment, will be recruited.

You may qualify if:

• Aged between 6 and 59 months
• Have been selected and accepted to receive SMC treatment (SP-AQ) in the intervention site and not in the control site
• Be able to take drugs

You may not qualify if:

• Child whose parents will no longer consent at some point in the study for one reason or another
• Children suffering from a chronic disease
• Intolerance to certain drugs

Sponsors & Collaborators

• Université de Parakou: lead
• Institut de Recherche pour le Developpement: collaborator
• University of Copenhagen: collaborator
• University of Ghana: collaborator
• Institut de Recherche Clinique du Bénin (IRCB): collaborator
• Hôpital Cochin: collaborator

Study Sites (1)

Azizath MOUSSILIOU

Parakou, Benin

Location

MeSH Terms

Conditions

Immune System Diseases; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Nicaise TIUKUE NDAM, Professor

  Institut régional de développement IRD (UMR261)

  STUDY CHAIR

• Adrian LUTY, Professor

  Institut régional de développement IRD (UMR261)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: December 14, 2022
• Study Start: June 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: May 30, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)