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

Award Number: U01AI195203
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/05/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2030

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Characterising the pharmacokinetics of tafenoquine for Plasmodium vivax radical cure in children ≥12 kg and >28 days old - PROJECT SUMMARY 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 <12 kg were enrolled. Measured tafenoquine blood concentration (AUC(0-¥)) values fell within the 95% predicted interval of the pharmacokinetic model (based on the 300mg dose in a 60kg adult). No serious safety issues were observed in this study. In children <2 years old and <12kg, pharmacokinetic data are lacking. To address this important research gap in small children, we propose conducting a multi-center open-label pharmacokinetic clinical trial in 2 malaria endemic countries. Currently the USA remains a non-endemic country and cannot support a malaria clinical trial. Aim 1 will characterize the pharmacokinetic properties of tafenoquine in small children ≤12kg and >28 days old. Aim 2 will assess the relationship of tafenoquine concentrations with CYP2D6 mutations and methemoglobin concentrations (a validated surrogate of radical curative activity) at day 7 after tafenoquine treatment. Aim 3 will assess the safety and tolerability of the tafenoquine dose for gastrointestinal effects, and changes in hemoglobin and blood methemoglobin concentrations. This study will provide the initial pharmacokinetic and pharmacodynamic evidence needed to support tafenoquine dosing in small children. This study will be conducted under an FDA Investigational New Drug (IND) so results can be applied to other indications. Potential utilization by US biotechs for pediatric formulations can be marketed in the US and globally thus, increasing American prosperity. Increasing access to effective radical cure accelerates malaria elimination, prevents outbreaks and reintroduction of malaria, keeping American populations safer.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $524,810 )
2026	2026	UNIVERSITY OF OXFORD	UNIVERSITY OFFICES	OXFORD				GBR	Allergy and Infectious Diseases Research	000	1	8/4/2026	NEW	$524,810
														Subtotal = $524,810

Grand Total All Awards = $524,810

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

Award Number: U01AI195203

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/05/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2030

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