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A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21

NCT05357560 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2026-05-12

No results posted yet for this study

Summary

This is a Phase Ib multi-stage Plasmodium falciparum malaria vaccine study to assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage vaccine candidate R21 in Matrix-MTM, both alone and in combination, in adults and infants in the Gambia

Conditions

  • Malaria, Plasmodium Falciparum

Interventions

BIOLOGICAL

Matrix-M with RH5.2 VLP and/or R21

3 doses of 50 µg of Matrix-M in combination with RH5.2 VLP and/or R21 at different doses and at different timepoints

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Medical Research Council Unit, The Gambia

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Umberto D'Alessandro · Medical Research Council Unit, The Gambia

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-10
Primary Completion
2025-12-11
Completion
2025-12-11

Countries

  • The Gambia

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 NCT05357560 on ClinicalTrials.gov