Project Title: A Multilateral Initiative to foster the Clinical Development of effective Malaria Vaccine Candidates in Africa
Project Description: Malaria remains a huge public health problem despite recent progress in disease control in many countries around the world. Although many tools are currently used to tackle malaria, an effective malaria vaccine is considered to be a potential game-changer towards the efforts for malaria elimination. Therefore, this study will determine if experimental malaria vaccine candidates are safe and efficacious in African malaria exposed adults using controlled human malaria infection platform. Specifically, the study aims: •... Malaria remains a huge public health problem despite recent progress in disease control in many countries around the world. Although many tools are currently used to tackle malaria, an effective malaria vaccine is considered to be a potential game-changer towards the efforts for malaria elimination. Therefore, this study will determine if experimental malaria vaccine candidates are safe and efficacious in African malaria exposed adults using controlled human malaria infection platform. Specifically, the study aims: • To assess the safety and tolerability of the malaria vaccine candidates against control/placebo in healthy, malaria-exposed adults (18-45 years) and infants (6-11 months). • To assess the efficacy of selected candidates against placebo in healthy, malaria-exposed adults in CHMI with 7G8 infected red blood cells by direct venous inoculation (DVI) 10 weeks after the last immunization. • • To assess the in-vitro P. falciparum growth inhibition activity of the vaccine-induced antibodies at 2.5mg/mL from infants who have received the candidate vaccine compared to those who have received placebo 4 weeks after the last immunization. By design, the study is a randomized, controlled, double-blind, single-center, phase 1/2 clinical trial in healthy adults and infants. The inclusion criteria to CRYSPY study will be the healthy adults aged 18 to 45 years and infants aged 6-11 months. Adults must be able and willing (in the Investigator's opinion) to comply with all study requirements and a residence in the study area or surroundings for the period of the trial. Volunteers from each adult and infant group will be randomized to receive one of the three candidate vaccines or control vaccine in a 2:1 randomization ratio. The target population for the blood-stage vaccine is infants and young children who are the most vulnerable populations that bear the largest burden of malaria morbidity and mortality. All vaccines will be administered by using the route, schedule, and dose recommended by the respective vaccine developer. Study interventions will be allocated according to the route of administration and immunization schedule to allow double-blinding and placebo comparison. The community permission will be obtained from key opinion leaders in the study area after the explanation and discussion of the study at a community meeting. Approval from the President's Office Regional Administration and Local Government to enter the community will be obtained before the recruitment starts. After the community permission has been obtained, individual volunteers will be invited to the study clinic for informed consent discussion and screening. The sponsor of the trial is IHI taking over the sponsor’s responsibilities. The sponsor will ensure that the CRISPY study complies with the appropriate national and international standards and guidance, regulations and legislation, notably the International Council on Harmonisation (ICH) E6(R2) Good Clinical Practice (GCP) guidelines, section 5.18, and FDA 21 CFR 312.50. The sponsor will subcontract monitoring services. The investigator must ensure the provision of reasonable time, space and qualified personnel for monitoring visits. The project will take place at the IHI Clinical Trial Facility located in Bagamoyo town (about 60 km north of Dar es Salaam).
Principal Investigator : Ally Olotu
Department Name : BRCT
Time frame: (2020-02-01) - (2025-01-31)
European and Developing Countries Clinical Trials Partnership Programme (EDCTP) (Normal)
External Collaborating Partners
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