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: Wellcome Trust, Institut de Recherche en Sciences de la Sante, Burkina Faso, European Vaccine Initiative, European and Developing Countries Clinical Trials Partnership (EDCTP), Bundesministerium für Forschung, Technologie und Raumfahrt (BMFTR)