drugset / Trial / NCT06265012
Study to Evaluate the Recombinant VSV (rVSV)-Marburg Virus Vaccine Candidate (PHV01) in Healthy Adult Subjects
Phase 1
Completed
36 enrolled
Public Health Vaccines LLC
Biomedical Advanced Research and Development Authority · collab
RandomizedSequentialQuadruple-blindPrevention
Summary
This is a Phase 1 randomized, single-blind, placebo-controlled, ascending dose study to evaluate the safety and immunogenicity of rVSV∆G-MARV-GP \[Angola\] (PHV01, Marburg Virus glycoprotein \[MARV GP\] Vaccine) in healthy adults. PHV01 is a live, attenuated rVSV vaccine expressing the MARV GP. The main questions it aims to answer are: * Which dose of PHV01 is safe to administer to, and well-tolerated by healthy adult subjects? * What is the immunologic response (Marburg-specific Immunoglobulin G (IgG) ELISA antibody and neutralizing antibodies) to each dose level? Participants will receive 1 intramuscular injection of PHV01 or placebo on Day 1 and will be followed for 181 days.
Timeline
- Start
- 2024-02-05
- Primary completion
- 2024-09-23
- Completion
- 2024-09-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PHV01 | Vaccine | 100000 unknown | Intramuscular |
| Subject | PHV01 | Vaccine | 1e+06 unknown | Intramuscular |
| Subject | PHV01 | Vaccine | 1e+07 unknown | Intramuscular |