Zika Vaccine Approved for Human Trials

The US Food and Drug Administration (FDA) has approved the initiation of a human clinical trial for an experimental vaccine for Zika virus.

Inovio Pharmaceuticals, based in Pennsylvania, and GeneOne Life Science, based in South Korea, created a vaccine to combat the sudden rise in Zika virus—a global health threat.

Preclinical tests, which were conducted on various animal models, showed the vaccine induced robust antibody and T-cell responses.
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The researchers will administer the vaccine in a range of doses to 40 healthy volunteers around the world. This will help the researchers determine the vaccine’s safety, tolerability, and immunogenicity in humans.

However, it may take several more years of testing before the vaccine becomes available to the public.

“We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers,” the researchers said.

“As of May 2016, 58 countries and territories reported continuing mosquito-borne transmission of the Zika virus; the incidences of viral infection and medical conditions caused by the virus are expanding, not contracting. We plan to dose our first subjects in the next weeks and expect to report phase I interim results later this year.”

—Amanda Balbi

Reference:

Inovio Pharmaceuticals and GeneOne Life Science receive approval for first-in-man Zika vaccine clinical trial [news release]. Plymouth Meeting, PA, and Seoul, South Korea: Inovio Pharmaceuticals; June 20, 2016. http://ir.inovio.com/news/news-releases/news-releases-details/2016/Inovio-Pharmaceuticals-and-GeneOne-Life-Science-Receive-Approval-for-First-in-Man-Zika-Vaccine-Clinical-Trial/default.aspx. Accessed June 20, 2016.