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The Mahidol Oxford Tropical Medicine Research Unit (MORU) has begun a Phase II trial to demonstrate that R21/matrix M is well-tolerated and immunogenic when administered with the antimalarial drug combination.

The Nuffield Department of Medicine’s MORU-FTM Clinical Trials Unit (CTU) is running clinical trials of a revolutionary malaria vaccine candidate, R21/Matrix-M™ – which previously demonstrated high-level efficacy of 77% in young African children in 2021, and continues to meet the WHO-specified 75% efficacy goal in trials in West Africa. This Phase II trial is specifically investing the vaccine’s efficacy when administered in combination with antimalarial drugs.

 

Three groups of 120 healthy, adult Thai volunteers will be randomised to receive: a) three rounds R21/matrix-M combined with antimalarial drugs (dihydroartemisinin/piperaquine and a single low dose primaquine) b) R21/matrix-M alone and c) antimalarial drugs alone. Study participants will be followed for six months after the first vaccine dose. Adverse events will be recorded initially daily, then weekly and finally monthly. IgG levels against epitopes on the circumsporozoite proteins will be assessed at 4 time points (M0, M1, M3, M6). As this is a safety and immunogenicity study, no exposure to malaria is intended. 

 

With prompt case management and the distribution of insecticide treated bed nets, falciparum malaria transmission is now at very low levels in many malaria-endemic regions of Asia. The addition of mass anti-malarial drug administration (MDA) can reduce and even interrupt falciparum malaria transmission for short periods. An effective vaccine that can confer protection combined with MDA may be sufficient to interrupt malaria transmission permanently. The R21/Matrix-M malaria vaccine has reached the WHO-specified goal of 75% or greater efficacy over 12 months in the target population of African children but has not yet been used in Asia. R21/Matrix M was developed by the Jenner Institute, at the Nuffield Department of Medicine and is now manufactured by the Serum Institute of India (SII PL), which produces vaccines in large volumes at affordable prices.

 

Funded by the Developmental Pathway Funding Scheme – UKRI, the MORU-FTM team includes Prof Sasithon Pukrittayakamee, Dr Borimas Hanboonkunupakarn, Mr Pongphaya Pongsuwan, Dr Podjanee Jittmala, Dr Kittiyod Poovorawan and Prof Lorenz von Seidlein. The trial is part of a global effort that includes ongoing trials in Burkina Faso.

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