A Phase IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of the Blood-stage Malaria Vaccine Candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in Infants Aged 5-17 Months in Burkina Faso.
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 1
Healthy Volunteers: t
View:
• Healthy infant aged 5-17 months at the time of first study vaccination
• Parent/guardian provides signed/thumb-printed informed consent
• Infant and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up for 12 months following last dose of vaccination.
Locations
Other Locations
Burkina Faso
Institut de Recherche en Sciences de la Santé
RECRUITING
Siglé
Contact Information
Primary
Jee-Sun Cho
vaccinetrials@ndm.ox.ac.uk
+44 (0)1865 611418
Time Frame
Start Date: 2023-04-03
Estimated Completion Date: 2026-05-30
Participants
Target number of participants: 480
Treatments
Placebo_comparator: Group 1 (Control group)
n= 60. Age= 5-17 months Rabies Vaccine administered on Days 0, 28 and 152.
Experimental: Group 2
n=120 Age= 5-17 months First vaccination of RH5.1 10μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 152.
Placebo_comparator: Group 3 (Control Group)
n= 60. Age= 5-17 months Rabies Vaccine administered on Days 0, 28 and 56.
Experimental: Group 4
n=120 Age= 5-17 months First vaccination of RH5.1 10μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 56.
Experimental: Group 5
n=120 Age= 5-17 months First vaccination of RH5.2-VLP 5μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 56.
Sponsors
Collaborators: Wellcome Trust, Institut de Recherche en Sciences de la Sante, Burkina Faso, European and Developing Countries Clinical Trials Partnership (EDCTP)
Leads: University of Oxford