Vaccine Testing Center Plays National Role in Global Research Effort
BETH KIRKPATRICK, M.D., PROFESSOR OF MEDICINE & DIRECTOR OF THE VACCINE TESTING CENTER
The University of Vermont's Vaccine Testing Center (VTC) plays a key role in the fight against infectious diseases that impact much of the world's population. Founded in 2002 by Beth Kirkpatrick, M.D., the VTC runs a fully functioning unit for performing domestic Phase I, II and III vaccine trials and enteric challenge models; international field trials in infectious disease; and exploratory work in human immunology. The VTC has made significant contributions to the development and testing of many vaccines against infectious diseases of global importance, including typhoid fever, dengue fever, Campylobacteriosis, and infections with West Nile virus, cholera, rotavirus and polio.
The last five years have been very productive at the VTC. Multiple early-stage clinical trials conducted since 2009 in conjunction with the National Institutes of Health (NIH) and Johns Hopkins University show promising results for a vaccine against dengue fever, a disease reported to infect 50 to 100 million individuals annually. Results from this series of trials were published in March 2013 in the Journal of Infectious Diseases, and showed that the investigational vaccines are safe and stimulate strong immune responses in most vaccine recipients.
In July 2013, the VTC and two other US sites launched a Phase III placebo-controlled clinical trial for a single-dose oral cholera vaccine, sponsored by PaxVax, a company dedicated to the development of socially responsible vaccines. "UVM is one of only a few U.S. sites with experience doing this type of vaccine-challenge study," says Kirkpatrick, "which is why we were approached to participate." Over the next year, the VTC will continue work with PaxVax in a new trial to evaluate the same oral cholera vaccine in an older population of volunteers. Cholera causes an estimated three to five million cases and a reported 100,000 to 120,000 deaths annually, according to the World Health Organization, and the need for a single-dose oral vaccine is critical to addressing its disease burden.
Most recently, the VTC launched recruitment efforts for a year-long Phase I trial of a live-attenuated West Nile virus vaccine, developed by the NIH. This vaccine has been studied in healthy adults ages 18–50 and has been found to be safe, well-tolerated and immunogenic. Again in collaboration with Johns Hopkins and the NIH, the VTC will evaluate the West Nile virus vaccine's safety and immunogenicity in an older population aged 45–60.
In addition to U.S.-based clinical trials, Kirkpatrick and colleagues from the University of Virginia received a Bill and Melinda Gates Foundation grant in 2011 supporting work to understand the spectrum of biologic and immunologic reasons for failure of oral polio and rotavirus vaccines in infants in Bangladesh and India. This four-year study enrolled over 1,000 infants in the urban slums of Dhaka and Kolkata, where oral vaccines underperform in the context of high levels of malnutrition and poverty. The study aims to find answers to better protect children in the developing world from death and disability due to vaccine-preventable diseases.
Last modified May 19 2014 03:55 PM