IDCRC launches clinical trail to study the safety and immunogenicity of an inactivated West Nile Virus vaccine
Infectious Diseases Clinical Research Consortium (IDCRC) researchers are conducting a clinical study to evaluate the safety and immunogenicity of an inactivated West Nile Virus (WNV) vaccine.
This Phase 1 trial aims to develop a vaccine for WNV, which is primarily transmitted to humans through mosquito bites. WNV is a common mosquito-borne disease that has spread throughout North America. There is currently no licensed vaccine for humans, and previous attempts have had limited success in generating a strong immune response. This trial will assess the safety and immunogenicity of the second-generation HydroVax-001B WNV vaccine, produced by Najit Techonolgies, Inc., in healthy male and female (non-pregnant and non-breastfeeding) adults aged 18 to 49 years.
“There are currently no West Nile vaccines available for people but four approved vaccines for horses. Yet there have been over 60,000 known cases of West Nile disease in Americans since 1999, and many more undiagnosed. This study tests a reformulated hydrogen peroxide inactivated whole viral vaccine in healthy adults for safety and immunogenicity. This is an important study advancing West Nile vaccine development,” shares Sarah George, MD, professor of infectious diseases, adjunct professor of microbiology, Saint Louis University (SLU), and lead site principal investigator.
“We believe this first-in-human phase one trial is very important and the SLU CVD is very excited to be leading this effort,” shares Daniel Hoft, MD, PhD, director of infectious diseases, allergy, and immunology at SLU and principal investigator for the Vaccine and Treatment Evaluation Unit.
The IDCRC is conducting the study in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. For details, visit ClinicalTrials.gov and search for the identifier NCT06745921.
This trial is of utmost importance for science and public health because it aims to develop a preventive vaccine that can protect both healthy individuals and vulnerable populations from severe illness, long-term health issues, and death caused by West Nile Virus (WNV) infection. This effort addresses a significant gap in current prevention strategies.
IDCRC principal investigator, David Stephens, MD, shares that the “prevention of mosquito-borne West Nile infections which can be devastating is a significant challenge. This phase I, first in humans’ study, is an important first step in finding a vaccine to prevent this serious illness.”
Participating IDCRC site:
- Saint Louis University Vaccine and Treatment Evaluation Unit
This activity is supported by the Infectious Diseases Clinical Research Consortium (IDCRC) through the National Institute of Allergy and Infectious Diseases (NIAID) (UM1AI148684). The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group, was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID. For more information about the IDCRC, please visit www.IDCRC.org.