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A Phase Ib Multi-stage Plasmodium Falciparum Malaria Vaccine Study to Assess the Safety and Immunogenicity of the Blood-stage Vaccine Candidate RH5.2 Virus-like Particle (VLP) in Matrix-M and the Pre-erythrocytic Stage Vaccine Candidate R21 in Matrix-M, Both Alone and in Combination, in Adults and Infants in the Gambia
This is a Phase Ib multi-stage Plasmodium falciparum malaria vaccine study to assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage vaccine candidate R21 in Matrix-MTM, both alone and in combination, in adults and infants in the Gambia
Details
| Lead sponsor | University of Oxford |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 107 |
| Start date | 2023-07-10 |
| Completion | 2025-12-11 |
Conditions
- Malaria, Plasmodium Falciparum
Interventions
- Matrix-M with RH5.2 VLP and/or R21
Primary outcomes
- To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing the occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits — 7 days following each vaccination
Occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits - To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing the occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits — 7 days following each vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits - To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing occurrence of unsolicited adverse events — 28 days following the vaccination
Occurrence of unsolicited adverse events via clinical review, clinical examination (including observations) and laboratory results - Safety of the RH5.2-VLP with Matrix-M and R21 with Matrix-M vaccine, assessed through the number of participants with abnormal laboratory test results — 28 days following the vaccination
Occurrence of change from baseline laboratory test results - Assessment of safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants assessed through the number of participants with serious adverse events — Whole duration of the study (24-30 months following initial trial vaccination)
Occurrence of serious adverse events including grading of causality
Countries
The Gambia