First experimental Zika vaccine gets nod from FDA, moves to human trials
The US Food and Drug Administration on Monday approved the first human trial of an experimental Zika vaccine, according to a joint announcement by the two companies behind the new therapy.
The companies, Inovio Pharmaceuticals, Inc., based in Pennsylvania, and GeneOne Life Science, Inc., based in South Korea, said that their DNA-based vaccine candidate, dubbed GLS-5700, will be given to 40 people in a phase I trail. The trial will start “in the next weeks,” the companies said, and could yield results later this year.
Inovio and GeneOne noted in their announcement that pre-clinical data from animal studies suggested that the vaccine could induce a strong immune response that might protect against mosquito-transmitted Zika. But, like all phase I trials, their upcoming human study will not test how effective the vaccine is at fighting off Zika virus, but rather its safety and appropriate dosage levels. If the DNA-based vaccine is found to be safe, it will then move on to larger trials on efficacy that will take years to complete.
