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A phase 1b age de-escalation dose escalation randomized, double-blind, Controlled Study of the Safety and Immunogenicity of heterologous prime-boost with the candidaye malaria vaccines AdCh63 RH5 and MVA RH5 administered Intramuscularly according to a 0,2-months vaccination schedule in haelthy adults,young children and infants in Tanzania

Principal Investigator: Ally Olotu

Project leader/ Coordinator:

Project Administrator: Priscilla Mlay

Funding Partner: The Chancellor Masters and University of Oxford

Start date: July 1, 2017

End date: June 30, 2021

A phase 1b age de-escalation dose escalation randomized, double-blind, Controlled Study of the Safety and Immunogenicity of heterologous prime-boost with the candidaye malaria vaccines AdCh63 RH5 and MVA RH5 administered Intramuscularly according to a 0,2-months vaccination schedule in haelthy adults,young children and infants in Tanzania

A phase 1b age de-escalation dose escalation randomized, double-blind, Controlled Study of the Safety and Immunogenicity of heterologous prime-boost with the candidaye malaria vaccines AdCh63 RH5 and MVA RH5 administered Intramuscularly according to a 0,2-months vaccination schedule in haelthy adults,young children and infants in Tanzania

Plasmodium falciparum reticulocyte- binding protein homolog 5 (PfRH5) IS A new generation and highly promising blood stage malaria vaccine antigen. Preclinical and early clinical data show the antigen elicts functional antibodies against merozoites in non-human primates and, malaria –maive UK adults in contrast to those elicited by natural malaria exposure.

The safety and capability of PfRH5 immunization to induce functional immune responses in adults, young children and infants residing in malaria endemic countries is unknown. Using an age de escalation dose-escalation randomized double blind controlled trial, and established immunological techniques, I will establish the safes and well tolerated dose of PFrh5 in adults, young children and infants and heterologous prime –boost approach will chimpanzee adenovorius 63 (ChAd63) and modifies vaccinia virus Ankara (MVA) expressing PfRH5.

The study will provide new knowledge with regards to the potential for PfRH5 as a malaria vaccine and inform decisions to conduct larger field trials to evaluate efficacy. The immunological outcomes will provide data on the human antibody response, to determine if there is scope to further improve the PfRH5 immunogen in future iterations of the vaccine.#