The world's first Zika vaccine is ready for human clinical trials after receiving the green light from the U.S. Food and Drug Administration (FDA) on Monday, June 20.
Inovio Pharmaceuticals (United Sates) and GeneOne Life Science (South Korea) have collaborated in the development of the GLS-5700 vaccine, which could be instrumental in fighting the global Zika virus epidemic.
During its preclinical testing state, the GLS-5700 vaccine successfully created a "robust antibody and T cell responses" in animal models. This shows that the vaccine has the potential to protect humans from infection.
The Phase 1 clinical trial will kick off in the next few weeks, during which the first stage will investigate the human subjects' tolerance of the vaccine as well as its safety.
The Zika vaccine will be tested in 40 healthy study participants. It will be administered intradermally using Inovio's proprietary DNA delivery device, Cellectra.
If the GLS-5700 vaccine passes the first round, further tests will be made upon approval.
"We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers," said Dr. J. Joseph Kim, President and CEO of Inovio. Kim added that they will report the results of the Phase 1 clinical trials later this year.
For the Zika vaccine, Inovio and GeneOne Life Sciences have teamed up with several researchers from the United States and Canada, including the Defense Advanced Research Projects Administration and the University of Pennsylvania. The two companies also worked with these researchers in the past to create vaccines for MERS and Ebola.
Anna Durbin, a member of the U.S. National Institutes of Health team who is working on a separate Zika vaccine, highlighted the importance of the first vaccine to go into human clinical trials.
"It means the FDA has reviewed it, and I'm sure is formulating questions and getting ready for additional candidates to submit their investigational drug applications," said Durbin, adding that the news means there is progress and momentum.
Last February, the World Health Organization (WHO) said that the world's first Zika vaccine could be 18 months away from the large-scale human clinical trials.
As of March, there were about 15 pharmaceutical companies working separately to develop a vaccine that could address the alarming epidemic. However, many of these endeavors are still in their early stages.
According to the U.S. Centers for Disease Control and Prevention, there were about 755 travel-related cases of Zika infection in the United States, along with one laboratory-acquired infection as of June 15, 2016.
