Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar

The resilience of P. vivax to malaria elimination efforts is due to its ability to form dormant liver stages (hypnozoites) that reactivate weeks to months after the initial infection causing recurrent episodes of malaria (relapses) and ongoing parasite transmission. Relapses account for a majority of recurrent infections and clinical cases of P. vivax malaria, and therefore have a significant effect on morbidity at the individual level. With current technology, it is not possible to directly measure hypnozoite biomarkers. Rather than directly detecting hypnozoites, our team developed an indirect approach by measuring antibodies induced by the primary blood-stage infection. Antibodies to different blood-stage antigens decay at different rates. Measuring antibodies to a carefully selected panel of P. vivax antigens can aid to identify individuals who have been infected within the previous 9 months (approximately the lifespan of hypnozoites). A serological test based on selected P. vivax antigens can detect recent exposure and predict future relapses. Coupling this test with a safe and efficacious primaquine treatment regimen, results in a population-based intervention to target the hypnozoite reservoir. This intervention is referred to as Plasmodium vivax Serological Testing and Treatment (PvSeroTAT). PvSTATEM is a cluster randomised trial in Madagascar and Ethiopia. This study will provide insights into the feasibility, acceptability, and efficacy of the PvSeroTAT approach. In this study, individuals, randomised by clusters, will be tested for the presence of serological markers of a recent P. vivax infection, followed by a targeted drug treatment intervention aimed at killing P. vivax hypnozoites.

NCT Number	NCT06923592
Lead Sponsor	London School of Hygiene and Tropical Medicine Collaborators: Institut Pasteur, Institut Pasteur de Madagascar, Armauer Hansen Research Institute, Ethiopia
Conditions	Malaria Vivax, Malaria Falciparum, Plasmodium Vivax, Plasmodium Falciparum
Enrollment	19,200 participants
Start Date	2025-05-12
Primary Completion	2027-04-28 (estimated)
Study Completion	2027-04-28 (estimated)
Updated on ClinicalTrials.gov	2026-03-24