From Our Partners
Friday, June 24, 2022
News on Pathogens and Preparedness
Global Biodefense
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
Global Biodefense
No Result
View All Result
Home Funding News

CRADA Opportunity for Evaluating Influenza Vaccines and Therapeutics

by Global Biodefense Staff
October 21, 2013

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.

From Our Partners
Tags: Animal ModelsAntiviralsH1N1H3N2InfluenzaVaccines

Related Posts

UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control
Medical Countermeasures

UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control

June 21, 2022
Biodefense Industry News
Industry News

Tonix Pharmaceuticals Opens Advanced Development Center for Vaccine Programs

June 20, 2022
Monkeypox Cases Prompt Additional Contracts for Bavarian Nordic Vaccine
Medical Countermeasures

Monkeypox Cases Prompt Additional Contracts for Bavarian Nordic Vaccine

May 30, 2022
Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors
Industry News

Novavax Missed Its Global Moonshot but Is Angling to Win Over mRNA Defectors

May 26, 2022
Load More

Latest News

Poliovirus Detected in London Sewage: Response Measures Emphasize Wastewater Surveillance and Vaccination Gaps

Poliovirus Detected in London Sewage: Response Measures Emphasize Wastewater Surveillance and Vaccination Gaps

June 22, 2022
UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control

UK Health Security Agency Widens Monkeypox Vaccine Umbrella for Outbreak Control

June 21, 2022
Influenza Research

New Way to Identify Influenza A Virus Lights Up When Specific Virus Targets are Present

June 20, 2022
Biodefense Industry News

Tonix Pharmaceuticals Opens Advanced Development Center for Vaccine Programs

June 20, 2022

Subscribe

  • About
  • Contact
  • Privacy
  • Subscribe

© 2022 Stemar Media Group LLC

No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe

© 2022 Stemar Media Group LLC