Actively Recruiting
Led by University of Oxford · Updated on 2025-03-07
480
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of Oxford
Lead Sponsor
I
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborating Sponsor
Researchers are evaluating the safety, immune response, and effectiveness of two blood-stage malaria vaccine candidates, RH5.1 in Matrix-M and RH5.2-VLP in Matrix-M, in infants aged 5 to 17 months living in Burkina Faso. This Phase IIb randomized controlled trial compares these vaccines against a rabies vaccine control to determine their ability to protect against malaria in a region where malaria is common. Participants will be randomly assigned to receive either the rabies vaccine, RH5.1 with Matrix-M, or RH5.2-VLP with Matrix-M. Vaccinations are administered in three doses on specific schedules: some groups receive doses on days 0, 28, and 56, while others receive the third dose later at day 152. Each dose contains a specific amount of the vaccine antigen combined with Matrix-M as an adjuvant. The study follows participants for 12 months after the last vaccination to monitor outcomes. During the study, infants will be closely monitored for malaria cases, vaccine safety, and immune responses through blood tests and clinical evaluations at multiple time points including before vaccination, after each dose, and during follow-up visits up to a year post-vaccination. Researchers will assess protection against clinical and asymptomatic malaria, immune responses, and blood-related complications. Safety checks occur monthly after vaccinations and at 6 and 12 months post-final dose to ensure participant well-being throughout the trial.
CONDITIONS
A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 months
Participants receive three vaccinations of either the experimental malaria vaccines RH5.1 or RH5.2-VLP with Matrix-M, or a rabies vaccine as control. The vaccinations occur on Day 0, Day 28, and a third dose between Day 56 and Day 152 depending on the group.
3 vaccination visits (in-person)
Duration - 12 months
Participants are followed for safety, immunogenicity, and efficacy assessments for 12 months after the final vaccination.
Multiple follow-up visits over 12 months
Total: 1 location
1
Institut de Recherche en Sciences de la Santé
Siglé, Boulkiemdé Province, Burkina Faso, BP 7192 OUAGADOUGOU 03, BF
Actively Recruiting
J
Jee-Sun Cho
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
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Hamtandi M Natama, Jo Salkeld, Athanase Somé...
https://pubmed.ncbi.nlm.nih.gov/39672183