drugset / Trial / NCT06320535
A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™
Phase 1
Active not recruiting
36 enrolled
University of Oxford
Bill and Melinda Gates Foundation · collabUniversity Hospitals Bristol and Weston NHS Foundation Trust · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults.
Timeline
- Start
- 2024-03-25
- Primary completion
- 2026-06
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 2.75 ug | Intramuscular |
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 3.5 ug | Intramuscular |
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 6.25 ug | Intramuscular |
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 12.5 ug | Intramuscular |
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 25 ug | Intramuscular |
| Subject | Matrix-M1 Adjuvant | Other / unclassified | 50 ug | Intramuscular |
| Subject | R21 | Vaccine | 0.5 ug | Intramuscular |
| Subject | R21 | Vaccine | 0.75 ug | Intramuscular |
| Subject | R21 | Vaccine | 1.25 ug | Intramuscular |
| Subject | R21 | Vaccine | 2.5 ug | Intramuscular |
| Subject | R21 | Vaccine | 5 ug | Intramuscular |
| Subject | R21 | Vaccine | 10 ug | Intramuscular |