Last Updated: 28/10/2022
Safety, immunogenicity, and efficacy of R21/Matrix-M and ChAd63/MVA-ME-TRAP in the context of controlled human malaria infection: A Phase IIb Trial in Kenyan Adults.
Objectives
The objective of this project is 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).
Principal Institution
Rationale and Abstract
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 Design
NCT number: NCT03947190
Study type: Interventional
Enrollment: 64 participants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
External reference
Thematic Categories
Date
Aug 2022 — Apr 2023
Funding Details
Project Site
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