Tuesday, September 4, 2012

Clinical trial in Thailand is among first in the world for live attenuated influenza vaccine for avian influenza

Embassy of the United States Bangkok Thailand
Today, Thailand became one of the first countries in the world to test an H5N1 avian influenza vaccine in a needle-free, nasal spray formulation. The development and testing of the new vaccine is part of the National Strategy Plan for Pandemic Preparedness that the Thai government released in 2005 in response to highly pathogenic H5N1 avian influenza outbreaks in Thailand. Avian influenza viruses such as H5N1 can be passed from infected birds to humans and have the potential of becoming a pandemic if the virus changes in a way that makes it easily contagious among humans.

This Phase I clinical trial of a live attenuated influenza vaccine (LAIV), the first step in testing new vaccines in humans, resulted from international collaboration between health agencies around the world, including the U.S. Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA). Through a grant to the World Health Organization, BARDA has provided funding and technical assistance to support Thailand’s GPO as well as other developing countries. The grant supported building pilot scale manufacturing facilities to produce the vaccine, devising a clinical trial process to study the vaccine’s effectiveness in protecting people against avian influenza and a regulatory process to evaluate the vaccine, as well as conducting clinical trials in humans.

Thailand’s GPO sent a dozen scientists to the United States for training in advanced bio-manufacturing skills and good manufacturing practices. BARDA established the training program and continues to sponsor the program at the North Carolina State University and Utah State University.

“Influenza vaccines remain a critical component of public health preparedness worldwide,” explained BARDA Director Robin Robinson, Ph.D. “By enhancing the capacity of developing countries to develop, manufacture, and test their own influenza vaccines, we are improving pandemic preparedness globally.”

Robinson noted that conducting this clinical trial demonstrates a milestone in international efforts to accelerate development of locally produced influenza vaccines. The study and data analysis for this clinical trial are expected to be completed by May 2013.


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