Zika virus vaccine Phase I clinical trial on humans set to begin in Quebec City

The Infectious Disease Research Centre (IDRC) and the Centre de recherche du CHU (Centre hospitalier de l’Université) at Laval University are set to begin the first clinical study for a Zika vaccine in Canada, after getting regulatory approval from Health Canada and the U.S. Food and Drug Administration to begin Phase I clinical trials.

The 16-month trial is a partnership with the University of Pennsylvania, which will also see testing on a group of human subjects, while 10-15 volunteers will participate in the trials at Laval.

“There is no existing treatment or vaccine for Zika,” said Gertrude Bourdon, president and CEO of CHU. “The vaccine currently being developed will be administered to humans for the first time as part of the clinical study. CHU de Québec-Université Laval is one of the three leading research centres involved in the vaccine study and we’re very proud of that.”

The vaccine, which has the working name GLS-5700, will be made by Inovio, based in Plymouth Meeting, Pennsylvania, and GeneOne Life Science, of Seoul, South Korea.

A so-called DNA vaccine, it is delivered into the site of injection on the skin via a short electrical pulse that propels the DNA, which has been coded to produce the protein that surrounds the Zika virus, to seek out human cells through a process called electroporation.

Ideally, the cells fight back by training the immune system to recognize the Zika virus as a foreign invader, and generating antibodies to fight it.

Inovio has indicated that its testing of the vaccine on mice and monkeys successfully triggered a robust antibody response.

Dr. Sylvie Trottier will lead the Quebec City team, under guidance from Gary Kobinger.

“We’re very proud to be part of the first international team in the world to complete all of the steps in the regulatory process and to be authorized by the Food and Drug Administration (FDA) and Health Canada to develop a Zika vaccine,” said Kobinger, doctor of microbiology, professor in Université Laval’s Faculty of Medicine, researcher with Centre de recherche du CHU, director of IDRC, and a global authority on vaccine research.

Kobinger has previous experience overseeing the optimization of the experimental Ebola treatment ZMapp at the National Microbiology Laboratory in Winnipeg.

At the moment, 18 companies and research organizations are known to be racing to develop Zika virus vaccines, including French pharmaceutical giant Sanofi SA in partnership with the U.S. Army, India’s Bharat Biotech, and the National Institute of Allergy and Infectious Diseases.

The Zika virus, which has been traveling quickly through South America and the Caribbean, is transmitted primarily by mosquito.

The World Health Organization forecasts a sharp increase in Zika infections, up to four million people, and that the virus constitutes a public health emergency, given that it causes birth defects.
The WHO says that ongoing transmission of the Zika virus has been reported in 61 countries and territories, and that 12 countries and territories have already reported Zika-related birth defects.
Women infected by the virus are at risk of either miscarrying or giving birth to children with microcephaly, a condition characterized by infants with abnormally shaped heads, although most cases of Zika under normal circumstances are relatively mild.

If all goes well with the Phase I trial, it should enter Phase II trials using a larger group of volunteer subjects in early 2017. Even so, it will be at least two years before a vaccine is available for mass distribution to patients.

The research team at the Infectious Disease Research Centre, contactable by phone at 418-654-2796, is currently looking for healthy adult volunteers to participate in the study.