Safety and Immunogenicity of SUM-101 Malaria Vaccine in Children and Infants Living in Burkina Faso

Launched by EUROPEAN VACCINE INITIATIVE · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new malaria vaccine called SUM-101 in young children and infants living in Burkina Faso. The researchers want to find out if the vaccine is safe for children aged 5 months to 5 years and how well it helps their bodies build protection against malaria. This will be the first time this vaccine is tested in such young children. The study will involve 69 healthy participants who will receive three doses of the vaccine over a couple of months. Some children will get the vaccine, while others will receive a rabies vaccine to compare results.

To be eligible for the study, children must live in the area and be generally healthy, meaning they don’t have serious health issues or allergies that would put them at risk. Parents or guardians should be available for follow-up visits after the vaccinations. Participants will have regular visits to the clinic for vaccinations and check-ups, where health workers will monitor them closely for any side effects in the days following each shot. This research is important as it could lead to a new way to protect children from malaria, a serious disease that affects many in the region.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Resident in the study area villages and participant's parent(s)/legal guardian anticipate being available for vaccination and follow-up for following last dose of vaccination.
• • Z-score of weight-for-age within ±2SD.
• Exclusion Criteria:
• • Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, major congenital defects, malnutrition requiring hospital admission and anaemia.
• • History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation.
• • Clinically significant laboratory abnormality as judged by the study investigator.
• • History of blood transfusion.
• • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
• • Previous vaccination with experimental malaria vaccines.
• • Participation in another research study/clinical trial involving receipt of an investigational medicinal product or planned use during the study period.
• • Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection (no HIV testing); asplenia; recurrent, severe infections and chronic immunosuppressant medication (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.