drugset / Trial / NCT03580824
A Study to Determine if a New Malaria Vaccine is Safe and Induces Immunity Among Kenyan Adults, Young Children and Infants
Phase 1/2
Completed
91 enrolled
University of Oxford
European and Developing Countries Clinical Trials Partnership (EDCTP) · collabKenya Medical Research Institute · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a clinical trial to evaluate the safety and immunogenicity of R21/MM in healthy Kenyan participants from the different age groups.Participants will receive 3 vaccinations 4 weeks apart.
Timeline
- Start
- 2019-04-30
- Primary completion
- 2022-06-14
- Completion
- 2022-06-14
Publications
- Mukhopadhyay ES, Bellamy DG, Tinto H, Hamaluba M, Truby A, Salman AM, Hill AVS. Naturally acquired immune responses to alpha-gal in malaria endemic settings and pre-clinical efficacy testing with R21/MM. Vaccine. 2025 Dec 5;68:127897. doi: 10.1016/j.vaccine.2025.127897. Epub 2025 Nov 1.
- Sang S, Datoo MS, Otieno E, Muiruri C, Bellamy D, Gathuri E, Ngoto O, Musembi J, Provstgaard-Morys S, Stockdale L, Aboagye J, Woods D, Lawrie A, Roberts R, Keter K, Kimani D, Ndungu F, Kapulu M, Njau I, Orindi B, Ewer KJ, Hill AVS, Bejon P, Hamaluba M. Safety and immunogenicity of varied doses of R21/Matrix-M vaccine at three years follow-up: A phase 1b age de-escalation, dose-escalation trial in adults, children, and infants in Kilifi-Kenya. Wellcome Open Res. 2023 Oct 12;8:450. doi: 10.12688/wellcomeopenres.19795.1. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | R21 | Vaccine | 5 ug | Intramuscular |
| Subject | R21 | Vaccine | 10 ug | Intramuscular |