A randomised trial of malaria vaccine R21/Matrix-M™ with and without antimalarial drugs in Thai adults

Borimas Hanboonkunupakarn; Mavuto Mukaka; Podjanee Jittamala; Kittiyod Poovorawan; Pongphaya Pongsuwan; Lisa Stockdale; Samuel Provstgaard-Morys; Kesinee Chotivanich; Joel Tarning; Richard M. Hoglund; Natenapa Chimjinda; Katie Ewer; Fernando Ramos-Lopez; Nicholas P.J. Day; Arjen M. Dondorp; Adrian V. Hill; Nicholas J. White; Lorenz von Seidlein; Sasithon Pukrittayakamee

doi:10.1038/s41541-024-00920-1

A randomised trial of malaria vaccine R21/Matrix-M™ with and without antimalarial drugs in Thai adults

Borimas Hanboonkunupakarn, Mavuto Mukaka, Podjanee Jittamala, Kittiyod Poovorawan, Pongphaya Pongsuwan, Lisa Stockdale, Samuel Provstgaard-Morys, Kesinee Chotivanich, Joel Tarning, Richard M. Hoglund, Natenapa Chimjinda, Katie Ewer, Fernando Ramos-Lopez, Nicholas P.J. Day, Arjen M. Dondorp, Adrian V. Hill, Nicholas J. White, Lorenz von Seidlein, Sasithon Pukrittayakamee

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Abstract

In preparation for mass vaccinations with R21/Matrix-M™ combined with mass administrations of dihydroartemisinin, piperaquine, and a single low dose primaquine we assessed the tolerability, safety, and potential interactions of this combination affecting immunogenicity or pharmacokinetics. 120 healthy Thai volunteers were randomised to receive either antimalarials combined with vaccinations (n = 50), vaccinations alone (n = 50), or antimalarials only (n = 20). Three rounds of vaccines and antimalarials were administered one month apart. The vaccine was well tolerated alone and in combination with the antimalarials. None of the participants failed completion of the 3-dose vaccine course. There was no significant difference in the vaccine immunogenicity or in the pharmacokinetics of piperaquine given individually or in combination. This study supports proceeding to a large trial of mass vaccinations with R21/Matrix-M™ combined with mass antimalarial administration in Bangladesh.

Original language	English
Article number	124
Journal	npj Vaccines
Volume	9
Issue number	1
DOIs	https://doi.org/10.1038/s41541-024-00920-1
Publication status	Published - Dec 2024

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Hanboonkunupakarn, B., Mukaka, M., Jittamala, P., Poovorawan, K., Pongsuwan, P., Stockdale, L., Provstgaard-Morys, S., Chotivanich, K., Tarning, J., Hoglund, R. M., Chimjinda, N., Ewer, K., Ramos-Lopez, F., Day, N. P. J., Dondorp, A. M., Hill, A. V., White, N. J., von Seidlein, L., & Pukrittayakamee, S. (2024). A randomised trial of malaria vaccine R21/Matrix-M™ with and without antimalarial drugs in Thai adults. npj Vaccines, 9(1), Article 124. https://doi.org/10.1038/s41541-024-00920-1

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abstract = "In preparation for mass vaccinations with R21/Matrix-M{\texttrademark} combined with mass administrations of dihydroartemisinin, piperaquine, and a single low dose primaquine we assessed the tolerability, safety, and potential interactions of this combination affecting immunogenicity or pharmacokinetics. 120 healthy Thai volunteers were randomised to receive either antimalarials combined with vaccinations (n = 50), vaccinations alone (n = 50), or antimalarials only (n = 20). Three rounds of vaccines and antimalarials were administered one month apart. The vaccine was well tolerated alone and in combination with the antimalarials. None of the participants failed completion of the 3-dose vaccine course. There was no significant difference in the vaccine immunogenicity or in the pharmacokinetics of piperaquine given individually or in combination. This study supports proceeding to a large trial of mass vaccinations with R21/Matrix-M{\texttrademark} combined with mass antimalarial administration in Bangladesh.",

author = "Borimas Hanboonkunupakarn and Mavuto Mukaka and Podjanee Jittamala and Kittiyod Poovorawan and Pongphaya Pongsuwan and Lisa Stockdale and Samuel Provstgaard-Morys and Kesinee Chotivanich and Joel Tarning and Hoglund, {Richard M.} and Natenapa Chimjinda and Katie Ewer and Fernando Ramos-Lopez and Day, {Nicholas P.J.} and Dondorp, {Arjen M.} and Hill, {Adrian V.} and White, {Nicholas J.} and {von Seidlein}, Lorenz and Sasithon Pukrittayakamee",

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doi = "10.1038/s41541-024-00920-1",

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Hanboonkunupakarn, B, Mukaka, M, Jittamala, P , Poovorawan, K, Pongsuwan, P, Stockdale, L, Provstgaard-Morys, S, Chotivanich, K, Tarning, J, Hoglund, RM, Chimjinda, N, Ewer, K, Ramos-Lopez, F, Day, NPJ, Dondorp, AM, Hill, AV, White, NJ, von Seidlein, L & Pukrittayakamee, S 2024, 'A randomised trial of malaria vaccine R21/Matrix-M™ with and without antimalarial drugs in Thai adults', npj Vaccines, vol. 9, no. 1, 124. https://doi.org/10.1038/s41541-024-00920-1

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AU - Hanboonkunupakarn, Borimas

AU - Mukaka, Mavuto

AU - Jittamala, Podjanee

AU - Poovorawan, Kittiyod

AU - Pongsuwan, Pongphaya

AU - Stockdale, Lisa

AU - Provstgaard-Morys, Samuel

AU - Chotivanich, Kesinee

AU - Tarning, Joel

AU - Hoglund, Richard M.

AU - Chimjinda, Natenapa

AU - Ewer, Katie

AU - Ramos-Lopez, Fernando

AU - Day, Nicholas P.J.

AU - Dondorp, Arjen M.

AU - Hill, Adrian V.

AU - White, Nicholas J.

AU - von Seidlein, Lorenz

AU - Pukrittayakamee, Sasithon

PY - 2024/12

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N2 - In preparation for mass vaccinations with R21/Matrix-M™ combined with mass administrations of dihydroartemisinin, piperaquine, and a single low dose primaquine we assessed the tolerability, safety, and potential interactions of this combination affecting immunogenicity or pharmacokinetics. 120 healthy Thai volunteers were randomised to receive either antimalarials combined with vaccinations (n = 50), vaccinations alone (n = 50), or antimalarials only (n = 20). Three rounds of vaccines and antimalarials were administered one month apart. The vaccine was well tolerated alone and in combination with the antimalarials. None of the participants failed completion of the 3-dose vaccine course. There was no significant difference in the vaccine immunogenicity or in the pharmacokinetics of piperaquine given individually or in combination. This study supports proceeding to a large trial of mass vaccinations with R21/Matrix-M™ combined with mass antimalarial administration in Bangladesh.

AB - In preparation for mass vaccinations with R21/Matrix-M™ combined with mass administrations of dihydroartemisinin, piperaquine, and a single low dose primaquine we assessed the tolerability, safety, and potential interactions of this combination affecting immunogenicity or pharmacokinetics. 120 healthy Thai volunteers were randomised to receive either antimalarials combined with vaccinations (n = 50), vaccinations alone (n = 50), or antimalarials only (n = 20). Three rounds of vaccines and antimalarials were administered one month apart. The vaccine was well tolerated alone and in combination with the antimalarials. None of the participants failed completion of the 3-dose vaccine course. There was no significant difference in the vaccine immunogenicity or in the pharmacokinetics of piperaquine given individually or in combination. This study supports proceeding to a large trial of mass vaccinations with R21/Matrix-M™ combined with mass antimalarial administration in Bangladesh.

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JO - npj Vaccines

JF - npj Vaccines

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ER -

A randomised trial of malaria vaccine R21/Matrix-M™ with and without antimalarial drugs in Thai adults

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