Actively Recruiting
Phase Ib Study of Safety and Immune Response to Multi-stage Malaria Vaccine R21 + RH5.1 + R78C With Matrix-M in Adults 18-35 and Children 5-17 Months in Burkina Faso
Led by University of Oxford · Updated on 2026-03-11
56
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
I
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of a multi-stage malaria vaccine candidate combining R21 with RH5.1 and/or R78C in Matrix-M adjuvant. This Phase Ib open-label study includes healthy adults aged 18 to 35 years and children aged 5 to 17 months in Burkina Faso. The study aims to test different combinations of these vaccines to better understand their effects in populations living in malaria-endemic areas. Participants are divided into six groups. Adults receive three doses of 5 µg R21 plus 10 µg RH5.1 and 10 µg R78C. Children receive different combinations of 5 µg or 10 µg doses of R21, RH5.1, and R78C vaccines. Each participant receives three intramuscular injections at months 0, 1, and 6, either in the deltoid muscle for adults or the anterolateral thigh for children. Safety monitoring includes staggered recruitment, sentinel participants, and Data Safety Monitoring Board reviews before age de-escalation and subsequent vaccinations. Participants will undergo safety assessments for solicited and unsolicited adverse events at multiple time points up to one year following the first vaccination. Blood samples for immunology testing will be collected at screening, vaccination days, and several follow-ups up to day 365. The study includes ongoing monitoring of serious adverse events and immune responses to evaluate how well the vaccine combinations are tolerated and stimulate the immune system over time.
CONDITIONS
Brief Title
A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 35 years and children aged 5 to 17 months at first vaccination
- Female adults must not be pregnant and must use effective contraception until three months after last vaccination
- Participant or parent/guardian provides informed consent
- Resident in study area and expected to be available for vaccination and follow-up
You will not qualify if you...
- Clinically significant congenital abnormalities or serious skin, cardiovascular, respiratory, endocrine, liver, renal, gastrointestinal, or neurological diseases
- History of cancer except certain skin or cervical cancers
- Children with severe malnutrition
- History of allergic reactions or anaphylaxis to vaccines
- Sickle cell disease
- Significant lab abnormalities
- Recent immunoglobulin or blood product use within three months
- Receipt of any vaccine within 14 days before or planned within 28 days after study vaccination
- Previous malaria vaccine
- Participation in other investigational studies within 30 days
- Alcohol misuse or injecting drug use
- Pregnant, lactating, or planning pregnancy during the trial
- Scheduled elective surgery requiring anesthesia during the trial
- Positive for hepatitis B, hepatitis C, or HIV; history of HIV exposure in children
- Immunosuppressive or immunodeficient states
- Any condition that may increase risk or affect study results
- Anaphylactic reaction to vaccine or pregnancy during study is a contraindication to further vaccination
- Acute illness or fever above 37.5°C at vaccination time may delay vaccination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive three doses of experimental malaria vaccines given as intramuscular injections in a 0, 1, and 6 month schedule. Vaccinations are administered to adults in the deltoid region and to children in the anterolateral thigh.
3 vaccination visits at Month 0, Month 1, and Month 6
Duration - Up to 12 months
Participants are monitored for safety and immune response after vaccination through blood sample collections and safety assessments up to one year from first vaccination.
Multiple visits for blood sample collection and safety assessments up to Day 365
Trial Site Locations
Total: 1 location
1
Institut de Recherche en Sciences de la Santé
Siglé, Boulkiemdé Province, Burkina Faso, BP 7192 OUAGADOUGOU 03, BF
Actively Recruiting
Research Team
N
Naomi N Kamau
A
Angela Minassian, Honorary Consultant and CI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
6
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