Project Title: Multi-Stage Malaria vaccine Consortium: Field efficacy testing of a malaria vaccine targeting all four stage of parasite's life cycle
Project Description: Short description of the Project/Consultancy/Platform: A high-efficacy malaria vaccine is urgently required to reduce the unacceptable burden of malaria mortality and morbidity in Africa and to assist efforts towards malaria elimination. An ideal malaria vaccine would target all stages of the parasite’s life-cycle but no such vaccine has reached clinical trials in Africa. We propose here to develop a very promising four-stage vaccine which will progress to a large phase IIb efficacy trial in West... Short description of the Project/Consultancy/Platform: A high-efficacy malaria vaccine is urgently required to reduce the unacceptable burden of malaria mortality and morbidity in Africa and to assist efforts towards malaria elimination. An ideal malaria vaccine would target all stages of the parasite’s life-cycle but no such vaccine has reached clinical trials in Africa. We propose here to develop a very promising four-stage vaccine which will progress to a large phase IIb efficacy trial in West and East African 5-9 month olds. All four components of the vaccine have strong validation. The anti-sporozoite vaccine component, R21, is a next-generation RTS,S vaccine with a simpler but equally potent adjuvant, matrix-M. This recently showed 82% sterile efficacy in a UK phase II sporozoite challenge trial using just 10 micrograms of R21 per dose (one-fifth of the standard RTS,S dose). The liver-stage vaccine employs adenoviral and MVA vectors that showed good safety and high efficacy in EDCTP-supported African trials and will now express conserved LSA1 and LSAP2 antigens that are more protective pre-clinically. The blood-stage component is the leading conserved PfRH5 antigen that induces high-titer cross-strain neutralizing antibodies in phase I trials. The sexual-stage antigen is the conserved Pfs25, multi-merized as a nanoparticle thereby enhancing antibody immunogenicity. We will undertake a tightly coordinated series of lead-in trials in 2018-2019 building towards a phase IIb efficacy trial in 5-9-month-olds in 2020-2022. We will first evaluate in East Africa the efficacy of the vaccine and its components in controlled human malaria infection trials, availing of this new capacity in Kenya and Tanzania. In Tanzania, we will conduct CHMI trial of the PfRH5/matrix-M malaria vaccine in Tanzanian adults, enrolling 60 subjects. The major hypothesis being addressed is that the PfRH5/matrix-M is safe and induce what may be protective immune responses in Tanzanian adults. The trial will take place at Bagamoyo, and will evaluate the safety, immunogenicity, and efficacy of the PfRH5/matrix-M vaccine against blood-stage CHMI in Tanzanian adults.
Principal Investigator : Ally Olotu
Department Name : BRCT
Time frame: (2018-01-01) - (2023-09-30)
European and Developing Countries Clinical Trials Partnership Programme (EDCTP) (Prime)
External Collaborating Partners
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