Phase I Human Trial of Zika Vaccine Approved
"We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers," said Dr. J. Joseph Kim, Inovio Pharmaceuticals, Inc.'s president and CEO. "We plan to dose our first subjects in the next weeks and expect to report phase I interim results later this year."
Inovio Pharmaceuticals, Inc. (Plymouth Meeting, Pa., and San Diego, Calif.) and GeneOne Life Science, Inc. (Seoul, South Korea) have received approval to initiate a phase I human trial to evaluate Inovio's Zika DNA vaccine to prevent infection from the virus, the companies announced June 20. In preclinical testing, the synthetic vaccine "induced robust antibody and T cell responses in small and large animal models, demonstrating the product's potential to prevent infection from this harmful pathogen in humans," they reported.
Their phase I, open-label, dose-ranging study with 40 healthy subjects will evaluate vaccine's safety, tolerability, and immunogenicity.
"We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers. 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," said Dr. J. Joseph Kim, Inovio's president and CEO.
"It is an honor for our company to help usher this Zika vaccine through the clinical and regulatory process. We look forward to conducting this trial with the goal of achieving products to combat this dreaded virus," agreed Young K. Park, GeneOne's president and CEO.
The two companies are developing the Zika vaccine, GLS-5700, with academic collaborators from the United States and Canada with whom they previously collaborated to advance Inovio's Ebola and MERS vaccines into clinical development.
Currently there is no vaccine or therapy for the Zika virus.