Characterising the pharmacokinetics of tafenoquine for plasmodium vivax radical cure in children ≥12 KG and >28 days old

The National Institute of Allergy and Infectious Diseases awarded a cooperative agreement totaling $524,810 to the University of Oxford on August 5, 2026, to characterize the pharmacokinetics of tafenoquine for Plasmodium vivax radical cure in children weighing 12 kilograms and older and at least 28 days old. The award is funded under the Allergy and Infectious Diseases Research program (CFDA 93.855).

The research addresses relapse prevention in pediatric P. vivax malaria infection, which causes repeated liver relapses unique to this parasite species and increases risk of severe anemia and rehospitalization, particularly in young children who lack developed immunity. Tafenoquine, a single-dose 8-aminoquinoline approved by the FDA in 2018, offers operational advantages over the traditional 7–14 day primaquine course, including improved adherence in pediatric populations where oral drug administration is difficult. The project builds on limited existing pediatric pharmacokinetic data from the TEACH study, which included children ages 2 to 15 years but covered a weight threshold below the current focus population.

Work is performed in Great Britain, United Kingdom, with a period of performance extending through June 30, 2030. The obligated amount is $524,810.

Abstract

In the united states (US), malaria transmission was halted in the 1940's. However, the first new autochthonous plasmodium vivax cases in 20 years were reported in 2023 in texas and florida, threatening the country's elimination status. Of concern are liver relapses unique to p. Vivax because they cause frequent and repeated infections. This affects health and disability in young children who are at the greatest risk of relapse as they have not developed immunity to infection. Relapses increase the risk of potentially lifethreatening anaemia and RE-hospitalization, and impair growth, school attendance and child development. Preventing relapse requires an 8-aminoquinoline (radical cure) - which until recently meant a 7-14 day course of primaquine. Low adherence decreases the effectiveness of radical cure especially for small children for whom oral drug administration is difficult. The newer single-dose tafenoquine is a safe well-tolerated alternative treatment, offering substantial operational benefits. Tafenoquine was developed in the 1980's by the walter reed army institute of research (wrair) following the earlier 1950's introduction of primaquine by the world war II antimalarial program. Tafenoquine was initially approved by the US federal drug administration (FDA) in 2018. The recommended dose is 300MG for persons ≥16 years old with G6PD activity >70%. A single published pharmacokinetic study on tafenoquine in pediatric populations (teach) included children ages 2 and 15 years. Although the weight threshold for inclusion was ≥5KG, no children