Project Title: Phase Ib trial to asses safety, reactogenicity, immunogenicity and efficacy of candidate blood-stage malaria vaccine, sumayavac-1 with GLA-SE as adjuvant in healthy malaria exposed African adults aged 18-45 years
Project Description: This is a single center, double blinded phase 1b trial to assess the safety, reactogenicity, immunogenicity of the SumayaVac-1 in GLA-SE and parasite growth rates after CHMI in healthy malaria pre-exposed African participants. The study is split in two parts: The vaccinations (Part 1) and the CHMI (Part 2). In part 1, 40 participants will be enrolled (male and female). Twenty participants will be randomized to receive three monthly inoculations with the investigational product, SumayaVac-1,... This is a single center, double blinded phase 1b trial to assess the safety, reactogenicity, immunogenicity of the SumayaVac-1 in GLA-SE and parasite growth rates after CHMI in healthy malaria pre-exposed African participants. The study is split in two parts: The vaccinations (Part 1) and the CHMI (Part 2). In part 1, 40 participants will be enrolled (male and female). Twenty participants will be randomized to receive three monthly inoculations with the investigational product, SumayaVac-1, and 20 participants will be randomized to receive the registered rabies vaccine (Verorab@) as controls. In Part 2, 25 participants (15 SumayaVac-1 & 10 Verorab vaccinated, selected randomly from the overall 40 participants) will undergo controlled human malaria infections (CHMI) with attenuated sporozoites 4 weeks after the 3rd vaccination. The participant will remain in confinement until they develop parasitemia of 500 parasites/uL malaria or complete day 28 post CHMI after which they will receive treatment with ALU plus a single low dose of Primaquine and discharged. Blood samples collected at different timepoints will be used to assess the safety and immunogenicity of the malaria vaccine.
Principal Investigator : Ally Olotu
Department Name :
Time frame: (2022-02-01) - (2024-11-30)
Swiss Tropical and Public Health Institute (Normal)
External Collaborating Partners
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