Testing a new malaria vaccine in infants in Burkina Faso

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.

This study is testing two new malaria vaccines in infants in Burkina Faso to see if they can help prevent malaria better than a rabies vaccine.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 480 (estimated)
• Ages: 5 Months to 17 Months
• Sex: All
• Sponsor: University of Oxford (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Siglé, Boulkiemdé Province)
• Trial ID: NCT05790889 on ClinicalTrials.gov

What this trial studies

This is a Phase IIb randomized controlled trial assessing the safety, immunogenicity, and efficacy of two experimental blood-stage malaria vaccines, RH5.1 and RH5.2, in infants aged 5-17 months in Burkina Faso. Participants will be randomly assigned to receive either a rabies control vaccine or one of the malaria vaccine candidates, with follow-up for 12 months post-vaccination. The study aims to compare the incidence of malaria cases between the vaccine groups and the control group to evaluate the effectiveness of the vaccines.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy infants aged 5-17 months living in the study area of Burkina Faso.

Not a fit: Patients with significant congenital abnormalities or severe allergic reactions to vaccines may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of malaria in young children, improving health outcomes in endemic regions.

How similar studies have performed: Other studies have shown promise in developing malaria vaccines, but this specific approach with these candidates is novel.

Eligibility criteria

Inclusion Criteria:

1. Healthy infant aged 5-17 months at the time of first study vaccination
2. Parent/guardian provides signed/thumb-printed informed consent
3. 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.

Exclusion Criteria:

* Clinically significant congenital abnormalities as judged by the PI or other delegated individual.
* Clinically significant skin disorder (psoriasis, contact dermatitis etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.
* Weight-for-age Z score of less than -3 or other clinical signs of malnutrition.
* History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunization.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
* Sickle cell disease.
* Clinically significant laboratory abnormality as judged by the study clinician.
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
* Receipt of any vaccine in the 7 days preceding enrolment, or planned receipt of any other vaccine within 7 days following each study vaccination.
* History of vaccination with another malaria vaccine.
* Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
* Known maternal HIV infection (no testing will be done by the study team).
* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (for corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day; inhaled and topical steroids are allowed).
* Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Where this trial is running

Siglé, Boulkiemdé Province

• Institut de Recherche en Sciences de la Santé — Siglé, Boulkiemdé Province, Burkina Faso (Recruiting)

Study contacts

• Principal investigator: Angela Minassian — Honorary Consultant and Chief Investigator - Project clinical trials
• Study coordinator: Jee-Sun Cho

Conditions Malaria,Falciparum