Actively Recruiting
A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)
Led by University of Oxford · Updated on 2026-03-11
56
Participants Needed
1
Research Sites
54 weeks
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
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.
CONDITIONS
Official 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...
- Healthy adults aged 18-35 years at first vaccination (Group 1)
- Healthy children aged 5-17 months at first vaccination (Groups 2-6)
- Female adults must not be pregnant and must use effective contraception until three months after final vaccination
- Participant or parent/guardian must provide signed or thumb-printed informed consent
- Participant or parent/guardian must reside in the study area and plan to be available for vaccinations and follow-up
You will not qualify if you...
- Clinically significant congenital abnormalities
- Significant skin, cardiovascular, respiratory, endocrine, liver, renal, gastrointestinal, or neurological disorders
- History of cancer except basal cell carcinoma of the skin or cervical carcinoma in situ
- Children with severe malnutrition (weight-for-age Z score below -3) or other clinical signs of malnutrition
- History of allergic reaction or anaphylaxis to immunisation
- Allergic diseases likely worsened by vaccine components
- Sickle cell disease
- Significant laboratory abnormalities at grade 2 or above
- Recent immunoglobulin or blood product administration within 3 months before vaccination
- Receipt of any vaccine within 14 days before enrolment or planned vaccination within 28 days after study vaccine
- Previous malaria vaccination
- Participation in other research with investigational products within 30 days before enrolment or planned during study
- Known or suspected alcohol misuse
- Known or suspected injecting drug use within 5 years before enrolment
- Pregnant, lactating, or planning pregnancy during the trial
- Scheduled elective surgery or procedures requiring general anesthesia during the trial
- Positive for hepatitis B surface antigen, hepatitis C, or HIV; for children, any history of HIV exposure
- Immunosuppressive or immunodeficient conditions including HIV, asplenia, recurrent severe infections, or recent immunosuppressant medication
- Any condition that may put the participant at risk or affect trial results or participation ability
- Contraindications to vaccination include anaphylactic reaction and pregnancy
- Acute moderate or severe illness or fever above 37.5°C at vaccination time may delay vaccination
AI-Screening
AI-Powered Screening
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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
CONTACT
A
Angela Minassian, Honorary Consultant and CI
CONTACT
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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