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Article History

Received: 12 February 2025

Accepted: 29 July 2025

First Online: 6 August 2025

Declarations

:

: The authors declare no competing interests.

: The MiPPAD study protocol and informed consent forms received approval from the Ethics Committee of the Faculty of Medicine of Cotonou, Benin, the Ethics Committee of the Hospital Clinic of Barcelona (Spain), the Comité Consultatif de Déontologie et d’Éthique of the Institut de Recherche pour le Développement (France), as well as all national ethics review committees and local regulatory bodies in each of the each malaria endemic countries participating in the study (Benin, Gabon, Mozambique, and Tanzania). In addition, the subsequent follow-up study received approval from the institutional review boards of both the University of Abomey-Calavi in Benin and New York University in the United States (IRB#09-1253). The trial was conducted under the provisions of the Declaration of Helsinki and in accordance with Good Clinical Practices guidelines set up by the WHO and by the International Conference on Harmonization. An independent Data Safety Monitoring Board (DSMB) was created prior to the beginning of the trial and regularly reviewed and monitored the safety data collected. The trial was registered prior to the enrollment of the first participant in both the ClinicalTrials.gov (NCT0081121) and in the Pan African Clinical Trials (PACTR2010020001429343) registries.

: Prior to each data collection wave, the study was explained in the local language to the participant and informed written consent was obtained. In cases where the participant could not read, an impartial person who was not involved in the study served as witness and observed the participant giving their thumbprint on the informed consent paperwork. Where applicable, consent was obtained from the parents or legal guardians of minors. Women were free to interrupt their participation at any time during the study.