West Nile Virus Vaccine Candidate HydroVax-001
HydroVax-001 is a West Nile Virus (NV) vaccine candidate with a hydrogen peroxide inactivated whole virion (WNV-Kunjin strain) adjuvanted with aluminum hydroxide. HydroVax-001 was discovered and developed by scientists at the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) in Portland. HydroVax-001 was created with a novel, hydrogen peroxide-based process that renders the virus inactive while maintaining key immune-system triggering surface structures. The OHSU research team, led by senior scientist Mark Slifka, Ph.D., created the investigational vaccine. The virus used to make the vaccine is inactivated and cannot cause WNV infection. Because it is inactivated, the experimental vaccine likely could be used in a diverse population, including immunologically vulnerable groups, such as the elderly.
The scientists were funded with a $7.2 million grant awarded in 2009 from the NIAID, part of the US National Institutes of Health. “Since first appearing in the United States in 1999, West Nile Virus has emerged as an important health threat in this country. NIAID is committed to research efforts to advance a preventive vaccine that could protect people against West Nile Virus infection,” said former NIAID Director Anthony S. Fauci, M.D.
The NIAID supports research on various vaccine approaches that could potentially lead to a safe and effective preventive vaccine for the West Nile virus. These approaches include vaccines containing cocktails of individual WNV proteins and chimeric vaccines, which combine genes from more than one virus into a single vaccine. A third approach involves DNA vaccines, in which DNA that codes for a particular virus protein is combined with bacterial DNA, and the combined product is injected directly into the skin of the person or animal being vaccinated.
HydroVax-001 is indicated to prevent the WNV but is not U.S. FDA-approved. The vaccine candidate is tested in a Phase 1 clinical trial at Duke University in Durham, N.C., one of NIAID’s Vaccine and Treatment Evaluation Units.
The HydroVax-001 vaccine is currently administered intramuscularly in a two-dose series. No pediatric vaccine efficacy indication has been disclosed.
September 30, 2019 - Oregon Health & Science University spinoff Najít Technologies, Inc., of Beaverton, Oregon, will test a yellow fever version of the HydroVax vaccine platform licensed from OHSU. A $3.1-million grant from the National Institutes of Health to Najít will enable Duke University to lead the Phase 1 human clinical trial and OHSU to study how trial participants’ immune systems respond to the yellow fever vaccine. The trial is expected to start in 2020 and take up to a year to complete.
January 18, 2019 - The HydroVax-001 WNV vaccine was modestly immunogenic and well-tolerated at all doses. HydroVax-001 was safe and well-tolerated, as there were no serious adverse events or concerning safety signals. At the 1 mcg dose, HydroVax-001 was not immunogenic by PRNT50 but elicited up to 41% seroconversion by WNV-specific ELISA in the per-protocol population (PP) after the second dose. At the 4 mcg dose, HydroVax-001 elicited neutralizing antibody responses in 31% of the PP following the second dose. In the presence of added compliment, PRNT50 seroconversion rates increased to 50%, and WNV-specific ELISA observed 75% seroconversion.
December 3, 2016 - Europe PMC published: Pre-clinical development of a hydrogen peroxide-inactivated West Nile virus vaccine.
July 9, 2015 - A new U.S. NIH-funded investigational vaccine to protect against West Nile Virus, discovered and developed by OHSU researchers, is entering Phase I clinical trials. The OHSU team, led by Mark Slifka, Ph.D., created the test vaccine, called HydroVax-001, with a novel hydrogen peroxide-based approach that renders the virus inactive while maintaining its integrity; an intact surface structure permits the triggering of an immune response to cells infected with the virus. This preparation will allow the test vaccine to be administered to a diverse population, including those most vulnerable to the virus, such as the elderly and immune-compromised individuals.
HydroVax-001 Vaccine Candidate Clinical Trial
Clinical Trial NCT02337868: Phase 1 Trial of Inactivated West Nile Virus Vaccine.
Phase 1 study results in July 2019: HydroVax-001 was safe and well-tolerated as there were no serious adverse events or concerning safety signals. At the 1 mcg dose, HydroVax-001 was not immunogenic by PRNT50 but elicited up to 41% seroconversion by WNV-specific ELISA in the per-protocol population (PP) after the second dose. At the 4 mcg dose, HydroVax-001 elicited neutralizing antibody responses in 31% of the PP following the second dose. In the presence of added compliment, PRNT50 seroconversion rates increased to 50%, and 75% seroconversion was observed by WNV-specific ELISA.
July 6, 2015 - A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Scientists at the Oregon National Primate Research Center at Oregon Health & Science University (OHSU) in Portland discovered and developed the experimental vaccine. The scientists were funded with a $7.2 million grant from NIAID, awarded in 2009. The new vaccine is being tested in a Phase 1 clinical trial at Duke University in Durham, North Carolina, one of NIAID’s Vaccine and Treatment Evaluation Units (VTEUs).