NCT03947190

A Study to Determine if New Types of Malaria Vaccines Are Safe, Effective and Lead to Immunity in Kenyan Adults

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	R21/Matrix-M	R21: Protein particle malaria vaccine candidate in Matrix-M: Saponin based vaccine adjuvant.
BIOLOGICAL	ChAd63/MVA ME-TRAP	ChAd63, chimpanzee adenovirus serotype 63; ME-TRAP, multiple epitope string fused to the thrombospondin-related adhesion protein; MVA, modified vaccinia Ankara.
BIOLOGICAL	intradermal injection (ID) or direct venous injection (DVI) of PfSPZ Challenge	PfSPZ Challenge: cryopreserved Plasmodium falciparum sporozoites.

Timeline

• Start date: 2022-08-31
• Primary completion: 2023-02-26
• Completion: 2023-02-26
• First posted: 2019-05-13
• Last updated: 2025-02-20

Locations

1 site across 1 country: Kenya