A Phase Ib Age De-escalation, Open Label Study of the Safety and Immunogenicity of the Multi-stage Malaria Vaccine Candidate R21 + RH5.1 + R78C in Matrix-M™ in Adults Aged 18-35 Years and Children Aged 5-17 Months in Burkina Faso
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5 months
Maximum Age: 35
Healthy Volunteers: t
View:
⁃ Only participants who meet all the inclusion criteria will be enrolled into the trial:
• Group 1: Healthy adult aged 18-35 years at the time of first study vaccination
• Group 2-6: Healthy child aged 5-17 months at the time of first study vaccination
• Group 1: Female participants must be non-pregnant (as demonstrated by a negative urine pregnancy .
⁃ test), and practice continuous effective contraception until three months after the final study vaccination
• Participant or parent/guardian provides signed/thumb-printed informed consent
• Participant (and parent/guardian for child participants) resident in the study area villages, and anticipated to be available for vaccination and the duration of follow-up -
Locations
Other Locations
Burkina Faso
Institut de Recherche en Sciences de la Santé
RECRUITING
Siglé
Contact Information
Primary
Naomi N Kamau
vaccinetrials@ndm.ox.ac.uk
+44 (0)1865611418
Backup
Angela Minassian, Honorary Consultant and CI
Time Frame
Start Date:2025-09-15
Estimated Completion Date:2026-10
Participants
Target number of participants:56
Treatments
Experimental: Group 1(n=8) adults (18-35years)
They will receive three doses of 5 µg R21 + 10 µg RH5.1 + 10 µg R78C, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
Experimental: Group 2 (n=8) Children aged between 5-17months
They will receive three doses of 5 µg R21 + 10 µg RH5.1, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
Experimental: Group 3 (n=8) children aged between 5-17 months
They will receive three doses of 5 µg R21 + 10 µg R78C, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
Experimental: Group 4 (n=8) Children aged between 5-17 months
They will receive three doses of 5 µg R21 + 10 µg RH5.1 +10 µg R78C , administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
Experimental: Group 5 (n=8) children aged 5-17 months
They will receive three doses of 5 µg R21, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
Experimental: Group 6 ( n=16) Children 5-17 months
They will receive three doses of 10 µg RH5.1 +10 µg R78C, administered at Month 0 (Day 0), Month 1 (Day 28), and Month 6 (Day 182), given as an Intramuscular injection to the deltoid region (adults) or anterolateral thigh (children)
Collaborators: European Vaccine Initiative (EVI), Wellcome Trust, Institut de Recherche en Sciences de la Sante, Burkina Faso, European and Developing Countries Clinical Trials Partnership (EDCTP), Bundesministerium für Forschung, Technologie und Raumfahrt (BMFTR)