Project Title: Epidemiology of Malaria Infection in Sub-Saharan African Countries (MAINZ) BNT000-003
Project Description: This is a prospective, multicenter, observational cohort study involving participants aged 5 to 60 years. The study aims to estimate the incidence of P. falciparum infections in selected countries of sub-Saharan Africa through regular blood testing using rapid diagnostic tests (RDT) and documentation of symptoms and treatment history. Additionally, thick blood smear (TBS) and quantitative polymerase chain reaction (qPCR) testing will be conducted during three follow-up visits. Our site will enroll a total of 350... This is a prospective, multicenter, observational cohort study involving participants aged 5 to 60 years. The study aims to estimate the incidence of P. falciparum infections in selected countries of sub-Saharan Africa through regular blood testing using rapid diagnostic tests (RDT) and documentation of symptoms and treatment history. Additionally, thick blood smear (TBS) and quantitative polymerase chain reaction (qPCR) testing will be conducted during three follow-up visits. Our site will enroll a total of 350 participants, with 75 participants in each of the age groups (5-11 years and 12-17 years) and 200 adults aged 18-60 years. The study will also gather data on factors associated with malaria prevention. As part of our exploratory objectives, we aim to provide insights into the natural history of P. falciparum infections, including the progression from asymptomatic to symptomatic status. The overall duration of participation for each individual will be six months. The findings from this study will inform the planning of Phase II/III vaccine efficacy trials in endemic countries in sub-Saharan Africa, aiming to develop a highly effective vaccine for active immunization against P. falciparum infection across all age groups. Objectives of the Study • To estimate site-specific incidence rates (IR) of P. falciparum infection through RDT testing, overall and by age group (5-11 years, 12-17 years, 18-60 years) during the active detection period. • To evaluate the agreement between RDT and TBS, and assess the sensitivity and specificity of RDT and TBS using qPCR as the gold standard for identifying P. falciparum infection at baseline and at two and six months after enrollment. To ensure participant safety, the study will adhere to ethical principles outlined in the Declaration of Helsinki 2013, consistent with Good Epidemiological Practice (GEP) and applicable local regulations. Prior to the commencement of the study, the study protocol and supporting documentation will be submitted to the IHI institutional review board (IRB) and the National Health Research Ethics Committee (NatHREC) for review and approval. A written confirmation of IRB/IEC approval or an exemption for research will be provided to the Sponsor before conducting any study-related fieldwork.
Principal Investigator : Ally Olotu
Department Name :
Time frame: (2025-02-17) - (2026-02-16)
BioNTech SE (Prime)
P95 CVBA (Normal)
External Collaborating Partners
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