PHV02 / Public Health Vaccines - LARVOL DELTA

Recombinant VSV vaccine (PHV02) for prevention of Nipah virus disease: safety and immunogenicity demonstrated in Phase 1 and 1b clinical trials (ASTMH 2025) - "Detailed safety and immunogenicity data from these Phase 1 studies will be presented. Continued clinical development of PHV02 is planned."

Clinical • Late-breaking abstract • P1 data • Infectious Disease

PHV02-C-102: Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=120 | Completed | Sponsor: Public Health Vaccines LLC | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

PHV02-C-102: Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=120 | Active, not recruiting | Sponsor: Public Health Vaccines LLC | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2024 ➔ Nov 2024

Enrollment closed • Trial primary completion date • Infectious Disease

A Phase 1 Study to Evaluate Safety & Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Public Health Vaccines LLC | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

A Phase 1 Study to Evaluate Safety & Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Public Health Vaccines LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

Study to Evaluate Safety and Immunogenicity of a Prime-Boost Regimen of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Public Health Vaccines LLC

New P1 trial • Infectious Disease

A Phase 1 Study to Evaluate Safety & Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Public Health Vaccines LLC | Trial primary completion date: Jun 2023 ➔ Mar 2024

Trial primary completion date • Infectious Disease

Immunological correlates of protection afforded by PHV02 live, attenuated recombinant vesicular stomatitis virus vector vaccine against Nipah virus disease. (PubMed, Front Immunol) - "Controls receiving rVSV-Ebola vaccine rapidly succumbed to NiV challenge, eliminating the innate immunity stimulated by the rVSV vector as a contributor to survival in monkeys challenged as early as 7 days after vaccination. It was concluded that PHV02 vaccine elicited a rapid onset of protection and that any detectable level of neutralizing antibody was a functional immune correlate of survival."

Journal • Dental Disorders • Ebola Virus Disease • Infectious Disease • Stomatitis

A Phase 1 Study to Evaluate Safety & Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Public Health Vaccines LLC | Trial primary completion date: Jan 2023 ➔ Jun 2023

Trial primary completion date • Infectious Disease

Development of a recombinant VSV vectored vaccine against Nipah Virus Disease (ASTMH 2022) - "A recombinant vesicular stomatitis virus (rVSV) expressing the glycoprotein (GP) of Ebola virus (rVSV-EBOV GP) has been approved for preventive immunization against Ebola (Ervebo®, Merck & Co.). Robust manufacturing methods have been developed and clinical immunological tests qualified. Based on the promising profile in animal models, this novel PHV02 NiV vaccine candidate has now entered clinical trials under an US FDA Investigational New Drug Application (IND)."

CNS Disorders • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

Recombinant vesicular stomatitis vaccine against nipah virus has a favorable safety profile: Model for assessment of live vaccines with neurotropic potential. (PubMed, PLoS Pathog) - "PHV02 is identical in construction to the registered Ebola vaccine (Ervebo) with the addition of the NiV G gene. The findings are important because they illustrate the complexities of phenotypic assessment of novel viral vectors with tissue tropisms determined by transgenic proteins, and because it is unprecedented to use a heterologous comparator virus (YF vaccine) in a regulatory-enabling study. This approach may have value in future studies of other novel viral vectors."

Journal • CNS Disorders • Dental Disorders • Infectious Disease • Stomatitis • EFNB2