A U.S. pharmaceutical company and its partner in South Korea report that they have received approval from the U.S. Food and Drug Administration to begin human safety trials on a possible first vaccine against Zika virus.
According to a joint press release this week by Pennsylvania-based Inovio Pharmaceuticals and GeneOne Life Science, headquartered in Seoul, South Korea, the Phase I trials will be conducted on 40 volunteers to determine how well the vaccine is tolerated, as well as how safe it is, at various dosage levels.
“We plan to dose our first subjects in the next weeks,” Dr. J. Joseph Kim, Inovio’s president and CEO, said in the press release, “and expect to report Phase I interim results later this year.”
Preliminary data from animal studies showed a “robust antibody and T cell responses,” the company said.
The Phase I trial won’t look at whether the vaccine effectively prevents people from being sickened by Zika, but if the vaccine is found to be safe and well tolerated, Phase II and III studies will examine whether it can stave off the virus, which was declared a global health emergency in February by the World Health Organization.
According to ABC News, the Inovio/GeneOne vaccine uses a dead version of the virus to provoke an immune-system response. Zika was declared a global public health emergency in February by the World Health Organization. When pregnant women contract the virus, which is spread mostly by mosquitos, it can cause their babies to be born with the serious birth defect of microcephaly, or an abnormally small head.
Earlier in June, the U.S. Centers for Disease Control and Prevention reported that three babies had been born in this country with Zika-related microcephaly and three pregnancies had been lost because of defects related to the virus. And last week, CDC Director Tom Frieden said that Zika rates were increasing so dramatically in Puerto Rico that hundreds of babies might be born with microcephaly there over the next year, ABC News and other outlets reported.
According to Reuters news agency, at least two other teams are working on a vaccine. Sanofi SA, located in France, is expected to begin tests on humans next year for its vaccine, and an Indian company is also at work on research and development.
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