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FDA Approves First Clinical Trial for Zika Vaccine
Ben Leach
David B. Weiner, Ph.D.

This week, the U.S. Food and Drug Administration approved the start of the first human clinical trial for a Zika vaccine, and The Wistar Institute’s  David B. Weiner, Ph.D., executive vice president, director of the Vaccine Center, and the W.W. Smith Professor in Cancer Research at Wistar, played a key role in the vaccine’s development.

Outbreaks of the Zika virus have grabbed national headlines as the World Health Organization reported the spread of the virus around the globe. A vaccine for the virus did not exist when these reports started arriving in 2015, prompting a dire need to address this global public health crisis.

Since last fall, Weiner has collaborated with Inovio Pharmaceuticals, Inc., GeneOne Life Science, Inc., Gary P. Kobinger, Ph.D., head of Special Pathogens, National Microbiology Laboratory at the Public Health Agency of Canada, and the University of Pennsylvania, among others, to develop the vaccine.

“We immediately connected to discuss as a team how to tackle the complex issues associated with creating a Zika vaccine,” said Dr. Weiner. “We looked at each other’s strengths and our ability to work earnestly and collaboratively to achieve this goal. At that time, there were a lack of reagents, a lack of understanding of the biology of this virus and no model systems.” 

What began as a plan to develop reagents, controls, animal models and potential vaccine candidates for initial testing had ultimately led to a phase I, 40-person trial that will evaluate the safety, tolerability, and effectiveness of the vaccine GLS-5700, manufactured by Inovio and GeneOne. The first participants will begin receiving the vaccine in the next few weeks.

There is currently no vaccine or treatment for Zika virus, a mosquito-borne disease that causes microcephaly in unborn babies, causing them to be born with smaller heads and brains, and Guillain-Barré syndrome, a nervous system disorder that can lead to near total paralysis. It is spreading quickly, with major outbreaks occurring in Africa, Southeast Asia, the Pacific Islands, many South American countries including Brazil, and reports of travel-related Zika cases in the United States.

Click here to read a press release about this groundbreaking clinical trial. You can also click here to watch NBC10's interview with Weiner and coverage of the announcement.