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Assessment of Safety, Immunogenicity and Efficacy of R21/Matrix-M1 Malaria Vaccine in Healthy WOCBP in Mali

NCT06080243 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2026-02-23

No results posted yet for this study

Summary

This will be a double-blind, individually randomised trial, to assess the safety, tolerability, immunogenicity, and protective efficacy of two and three doses of the R21/Matrix-M1 malaria vaccine or placebo given at 4 week intervals in healthy women of childbearing potential (WOCBP), who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future.

Participants will be randomised in Year 1 into three groups in a 1:1:1 ratio:

* Arm 1 (n=110): will receive three doses of R21/Matrix-M1 malaria vaccine at months 0, 1 and 2.
* Arm 2 (n=110): will receive normal saline (placebo) at month 0 and two doses of R21/Matrix-M1 malaria vaccine at months 1 and 2.
* Arm 3 (n=110): will receive three of doses normal saline (placebo) at months 0, 1 and 2. In Year 2: Non-pregnant participants in arms 1 and 2 will be randomised in a 1:1 ratio to receive a booster dose of R21/Matrix-M1 malaria vaccine or placebo at the beginning of the malaria transmission season. Participants in the control group (arm 3) will receive normal saline (placebo).

Initial follow-up will be for two years after dose three, with an efficacy analysis at 6, 12, 18 and 24 months after dose 3.

Participants will be monitored for safety, tolerability, immunogenicity, and malaria infection during the follow-up period.

Participants will also be monitored for pregnancy over 12 months post primary and booster vaccination and those who become pregnant will be followed during their pregnancy and for 1 year post-delivery (as well as their offspring) for safety and malaria infection

Conditions

  • Healthy Women of Child Bearing Potential

Interventions

BIOLOGICAL

R21/Matrix-M1

10 µg of R21 and 50 µg of Matrix-M1

BIOLOGICAL

Saline and R21/Matrix-M1

Saline and 10 µg of R21 and 50 µg of Matrix-M1

OTHER

Sterile isotonic (0.9%) normal saline

Saline

Sponsors & Collaborators

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • European Vaccine Initiative

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Adrian Hill, MD · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2027-09-01
Completion
2027-12-31

Countries

  • Mali

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 NCT06080243 on ClinicalTrials.gov