Epidemiology of Malaria Infection in Sub-Saharan African Countries

Ifakara Health Institute is set to conduct the Epidemiology of Malaria Infection in Sub-Saharan African Countries project in collaboration with BioNTech SE, Germany. This milestone research project aims to assess malaria infection rates and provide essential data for future vaccine trials.

The study will run from February 17, 2025, to February 17, 2026, and will be led by Ifakara scientists Ally Olotu (Principal Investigator) and Dr. Nicolaus Gutapaka (Project Leader). It will be conducted in collaboration with other research institutions including, NIMR Tanga, Centre de Recherches Médicales de Lambaréné" (CERMEL) in Gabon, Manhica Health Research Centre (MHRC) in Mozambique, and UVRI-IAVI HIV Vaccine Program and IDRC Tororo General Hospital in Uganda, targeting malaria transmission patterns across multiple African sites.

Rationale of the study
Malaria remains a significant public health challenge, with the WHO African Region accounting for 94% of global malaria cases and 95% of related deaths. While two vaccines (RTS, S/AS01 and R21/Matrix-M) are recommended for young children, no vaccine currently targets older children, adolescents, or adults. BioNTech is working towards a highly efficacious P. falciparum vaccine, aiming to prevent infection, disease, and death while supporting malaria elimination efforts.

The findings will provide insights into malaria infection dynamics across different age groups, furthering efforts to develop broader vaccination strategies beyond young children.

Study design and objectives
The study is a prospective, multicenter, observational cohort study involving 2,100 participants across six sites in four African countries. Ifakara will enroll 350 participants in Chalinze, categorized into three age groups: 5-11 years (75 participants), 12-17 years (75 participants), and 18-60 years (200 participants).

Participants will undergo regular blood testing using Rapid Diagnostic Tests (RDTs), thick blood smear (TBS), and quantitative polymerase chain reaction (qPCR) at scheduled follow-ups. The primary objective is to estimate the site-specific incidence rate (IR) of P. falciparum infections using RDTs across different age groups. Secondary objectives include:

1. Evaluating agreement between RDT and TBS, and to evaluate the sensitivity and specificity of RDT and TBS using quantitative polymerase chain reaction (qPCR) as the gold standard for the identification of malaria infection, at baseline, at two and six months after enrolment.
2. To estimate the site-specific IR of P. falciparum infections detected by both active and passive surveillance over the complete follow-up period (0-6 months), overall and by age group (5-11 years, 12-17 years, 18-60 years).

Study population and eligibility
The study will recruit male and female residents of Chalinze aged 5-60 years who have lived in the study area for at least 26 months and have no plans to travel for more than one week during the study period. Informed consent (or assent for minors) will be required.

Case ascertainment and treatment
Participants testing positive for P. falciparum (via RDT and/or TBS) during study follow-ups will be referred to partner health facilities for treatment. The incidence will be defined based on new infections observed during the follow-up period. Passive case detection systems will be implemented at study sites according to local standards.

This collaborative effort between Ifakara, BioNTech, and other partner institutions marks a significant step toward reducing the malaria burden in Africa. The Epidemiology of Malaria Infection in Sub-Saharan African Countries Study is expected to contribute valuable insights into malaria transmission dynamics across multiple age groups, supporting the design of future malaria control and elimination strategies. The study will be conducted after receiving the ethical approval from IHI IRB and NatHREC