A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.

Launched by UNIVERSITY OF OXFORD · Mar 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new malaria vaccine designed for infants aged 5 to 17 months in Burkina Faso. The goal is to see how safe and effective this vaccine is in protecting young children from malaria, a serious disease caused by parasites that can lead to severe illness. The trial will involve giving infants the vaccine and monitoring them for up to 12 months to check how well their bodies respond to it and to ensure there are no significant side effects.

To participate in the trial, infants must be healthy and live in the study area. Their parent or guardian must also agree to the study by signing a consent form. However, there are certain health conditions that would exclude a child from participating, such as serious allergies, certain chronic illnesses, or severe malnutrition. If eligible, families can expect regular check-ups and support throughout the yearlong study period, helping to contribute to important research that could lead to better malaria prevention in the future.

Gender

ALL

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.