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

NCT03947190 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-20

No results posted yet for this study

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).

Conditions

  • Malaria,Falciparum

Interventions

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.

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-02-26
Completion
2023-02-26

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03947190 on ClinicalTrials.gov