drugset / Trial / NCT05270265
Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine
Non-randomizedParallel-groupOpen-labelPrevention
Summary
This is an open-label, single-centre, non-randomised, first-in-human Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant.
Timeline
- Start
- 2022-02-09
- Primary completion
- 2023-07-31
- Completion
- 2023-07-31
Outcome
Outcome not reported
Stopped: “The study was terminated due to administrative delays in the approval of a substantial amendment to extend the shelf-life of Pvs25-IMX313. Regulatory approval was only received on 11 August 2023, after end of study visits had already been conducted.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pvs25-IMX313 | Vaccine | 10 ug | Intramuscular |
| Subject | Pvs25-IMX313 | Vaccine | 50 ug | Intramuscular |
| Background | Matrix-M1 | Other / unclassified | 50 ug | Intramuscular |