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Assessment of Safety, Immunogenicity and Efficacy of R21/Matrix-M1 Malaria Vaccine in Healthy WOCBP in Mali
Sponsor: University of Oxford
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
Official title: A Phase II Randomised, Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of the R21/Matrix-M1 Malaria Vaccine in Healthy African Women of Childbearing Potential in Mali
Key Details
Gender
FEMALE
Age Range
18 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
330
Start Date
2025-03-19
Completion Date
2027-12-31
Last Updated
2026-02-23
Healthy Volunteers
Yes
Conditions
Interventions
R21/Matrix-M1
10 µg of R21 and 50 µg of Matrix-M1
Saline and R21/Matrix-M1
Saline and 10 µg of R21 and 50 µg of Matrix-M1
Sterile isotonic (0.9%) normal saline
Saline
Locations (1)
Koumantou Study Clinic
Bougouni, Sikasso, Mali