drugset / Trial / NCT04318002
Safety and Immunogenicity of RH5.1/Matrix-M in Adults and Infants Living in Tanzania
Phase 1
Completed
60 enrolled
University of Oxford
European and Developing Countries Clinical Trials Partnership (EDCTP) · collabIfakara Health Institute · collab
RandomizedSequentialOpen-labelPrevention
Summary
This is an age de-escalation, dose-escalation open label randomised trial studying the safety and immunogenicity of RH5.1/Matrix-M, administered intramuscularly in healthy adults, young children and infants in Tanzania
Timeline
- Start
- 2021-01-21
- Primary completion
- 2023-08-27
- Completion
- 2023-08-27
Publications
- Silk SE, Kalinga WF, Salkeld J, Mtaka IM, Ahmed S, Milando F, Diouf A, Bundi CK, Balige N, Hassan O, Mkindi CG, Rwezaula S, Athumani T, Mswata S, Lilolime NS, Simon B, Msami H, Mohamed M, David DM, Mohammed L, Nyaulingo G, Mwalimu B, Juma O, Mwamlima TG, Sasamalo IA, Mkumbange RP, Kamage JJ, Barrett JR, King LDW, Hou MM, Pulido D, Carnrot C, Lawrie AM, Cowan RE, Nugent FL, Roberts R, Cho JS, Long CA, Nielsen CM, Miura K, Draper SJ, Olotu AI, Minassian AM. Blood-stage malaria vaccine candidate RH5.1/Matrix-M in healthy Tanzanian adults and children; an open-label, non-randomised, first-in-human, single-centre, phase 1b trial. Lancet Infect Dis. 2024 Oct;24(10):1105-1117. doi: 10.1016/S1473-3099(24)00312-8. Epub 2024 Jun 13.
- Mwamlima TG, Mwakasungula SM, Mkindi CG, Tambwe MM, Mswata SS, Mbwambo SG, Mboya MF, Draper SJ, Silk SE, Mpina MG, Vianney JM, Olotu AI. Understanding the role of serological and clinical data on assessing the dynamic of malaria transmission: a case study of Bagamoyo district, Tanzania. Pan Afr Med J. 2022 Oct 7;43:60. doi: 10.11604/pamj.2022.43.60.35779. eCollection 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 25 ug | Intramuscular |
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 50 ug | Intramuscular |
| Subject | RH5.1 | Vaccine | 10 ug | Intramuscular |
| Subject | RH5.1 | Vaccine | 50 ug | Intramuscular |