NCT05178901

A Phase 1 Study to Evaluate Safety & Immunogenicity of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response and Open-Label or Single Blind Booster Study to Evaluate the Safety and Immunogenicity of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Public Health Vaccines LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

Detailed description

A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

Conditions

• Nipah Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	PHV02	live, recombinant virus consisting of vesicular stomatitis virus (VSV; Indiana) with the gene for the Zaire ebolavirus glycoprotein (GP) (EBOV GP) replacing the gene for the VSV GP; in addition, the Nipah virus (NiV) G protein is also inserted and expressed. The vaccine is administered as a single intramuscular injection
OTHER	Placebo	Lactated Ringer's Solution. The placebo will be administered as a single intramuscular injection

Timeline

• Start date: 2022-01-10
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2022-01-05
• Last updated: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study