First Zika vaccine test in humans gets green light

Jun 20, 2016, 6:09 PM EDT
(Source: Partha S. Sahana/flickr)
(Source: Partha S. Sahana/flickr)
U.S. regulators have approved drug developer Inovio Pharmaceuticals and GeneOne Life Sciences to test a Zika vaccine in humans. Reuters reports:
The early-stage study will enroll 40 healthy subjects and evaluate safety, tolerability and immune response generated by the vaccine GLS-5700.
"We plan to dose our first subjects in the next weeks and expect to report phase I interim results later this year," Inovio CEO J Joseph Kim said.
In February, the World Health Organization (WHO) declared Zika a global public health emergency. The virus has been associated with microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.
In the animal testing stage, the vaccine caused a strong antibody response, the company said.
It is still very early in the vaccine's development. Phase I of a vaccine trial ensures that it can be tolerated well in human subjects.
If successful in this first round of human testing, it will need additional approval for further testing.
Newer vaccines have been designed using only the most important parts of a microbe, and labs have been paring those parts down to DNA. Inovio's vaccine uses an artificial DNA sequence inserted into a piece of genetic material called a plasmid, which is like a little package that's easily taken up by cells.
Zika's spread fast across Latin America and the Caribbean. While the virus usually only causes a mild infection, and often no symptoms at all, it causes severe birth defects if a pregnant woman becomes infected.