The National Institute of Allergy and Infectious Diseases (NIAID) is looking to enter into a Cooperative Research and Development Agreement (CRADA) with one or more biotechnology or biomedical companies to use the Influenza A Healthy Volunteer Challenge Model developed by NIAID for the purposes of developing new influenza drug treatments or vaccines.
Because animal models of influenza are limited in their ability to replicate human disease, new drug development and the search for better vaccines and vaccine strategies will require significant clinical development. In an effort to facilitate these clinical studies, NIAID has developed the Influenza A Healthy Volunteer Challenge Model using challenge viruses which are reverse genetics produced and cell cultured wild-type influenza A viruses for use in healthy volunteers under an Investigational New Drug (IND) application with the FDA.
The Influenza A Healthy Volunteer Challenge Model stands to streamline and reduce the cost of evaluating candidate vaccines and treatments. Specifically, clinical studies of influenza are expensive and inefficient due to the large numbers of subjects needed to determine the efficacy of a new treatment or vaccine, and they are limited in their ability to provide standardized data due to an inability (1) to identify the timing of viral exposure and development of disease and (2) to assess pre-exposure immunity. These factors limit the success of such studies and an investigator’s ability to evaluate the efficacy of a vaccine or therapeutic as well as to study the natural history and pathogenesis of this global disease. In a well-characterized challenge model such as this, the number of volunteers needed for subsequent efficacy studies will be smaller and the resulting data more informative.
Currently NIAID has an A(H1N1)pdm09 Influenza virus available under an IND and plans to use its method of reverse genetics and cell culture to produce additional influenza strain preparations, including strain A/H3N2, for use in human studies.
This first challenge virus been evaluated in the NIAID’s Influenza A Healthy Volunteer Challenge Model and an optimal dose and well as methods of performing this type of study have been established. This validated model of infection in these volunteers will allow more efficient and cost-effective phase II clinical evaluation of antivirals and vaccines, as well as an opportunity to study correlates of protection and the natural history and pathogenesis of influenza in a controlled setting. In NIAID’s model, the timing of exposure will be known, a standard dose identified and used, and many other potentially confounding variables controlled for.
Prospective CRADA partners are expected to provide a written capability statement prior to consideration by NIAID. Further details are avaialble under Solicitation Number: NIAID-TTIPO-2012-002.