This is a phase IIb clinical trial in malaria-exposed individuals to assess the immunogenicity, safety and efficacy of the two vaccines in the context of controlled human malaria infection, P. falciparum sporozoite challenge (PfSPZ Challenge).
A total of 64 participants will be enrolled for challenge and divided into four groups as follows: * 20 participants to receive R21/Matrix M (R21/MM) with intradermal PfSPZ Challenge; * 20 participants to receive viral-vectored ME-TRAP with intradermal PfSPZ Challenge; * 10 participants to receive R21/MM with direct venous inoculation PfSPZ Challenge; and * 14 participants comprising of the control group with intradermal PfSPZ Challenge. Blood tests and clinical assessments will be conducted to screen out participants with health conditions that may impact participation in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
R21: Protein particle malaria vaccine candidate in Matrix-M: Saponin based vaccine adjuvant.
ChAd63, chimpanzee adenovirus serotype 63; ME-TRAP, multiple epitope string fused to the thrombospondin-related adhesion protein; MVA, modified vaccinia Ankara.
PfSPZ Challenge: cryopreserved Plasmodium falciparum sporozoites.
KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast
Kilifi, Kenya
Occurrence of solicited local and systemic reactogenicity signs and symptoms, and unsolicited adverse events
Assessing the safety and reactogenicity of adjuvanted R21/MM and heterologous prime- boost regime of ChAd63-MVA ME-TRAP in healthy adult volunteers
Time frame: Solicited AEs are collected for 7 days post vaccination and unsolicited AEs for 28 days post vaccination
Occurrence of P. falciparum parasitemia assessed by PCR, and parasite density dynamics assessed by PCR, against malaria sporozoite challenge
To assess the safety of intradermal sporozoite infection dose in semi-immune healthy adult volunteers
Time frame: up to 3 months after malaria sporozoite challenge
Occurrence of P. falciparum parasitemia, assessed by qPCR
To assess the efficacy of adjuvanted R21 and heterologous prime- boost regime of ChAd63-MVA ME-TRAP against malaria sporozoite challenge, in healthy adult volunteers
Time frame: from vaccination day up to 90 days after malaria sporozoite challenge
To measure cellular immunogenicity assessed by ELISPOT
Assessing cellular immunogenicity by ELISPOT to enumerate IFN-ƴ producing T cells
Time frame: from vaccination day up to 90 days after malaria sporozoite challenge
To measure humoral immunogenicity assessed by ELISA
Assessing humoral immunogenicity by ELISA to quantify antibodies to the vaccine components CS, NANP, TRAP and HBsAb.
Time frame: from vaccination day up to 90 days after malaria sporozoite challenge
Parasite density dynamics assessed by qPCR
To assess any differences in efficacy estimates with ID versus DVI challenge in individuals receiving R21/MM
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Time frame: up to 3 months after malaria sporozoite challenge