Inovio Pharmaceuticals plans to start a Phase I clinical trial of its experimental Zika vaccine in the next few weeks. The Zika vaccine candidate is the first to be approved to enter clinical trials by the US Food and Drug Administration (FDA).
The vaccine – dubbed GLS-5700 – is being jointly developed by Pennsylvania-based Inovio pharmaceuticals and South Korea-based GeneOne Life Science. The proposed Phase I clinical trial will involve 40 healthy volunteers to test the safety and of the vaccine as well as the immune response it elicits.
“We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers,” said Dr. J. Joseph Kim, Inovio’s President & CEO. “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.”
According to Inovio, preclinical results for the Zika vaccine have been promising. In both small and large animal models, the experimental vaccine was capable of inducing strong antibody and T cell responses.
The Zika virus – which is spread by a mosquito vector – has been associated with severe birth defects in infants, including microcephaly. According to a recent report from the Centers for Disease Control and Prevention (CDC), the epidemic has now spread to Puerto Rico, with over 1,700 cases of the disease identified there so far.
Though the virus has yet to spread to the Southern US states, the CDC has reported that three babies born with birth defects in the US have been linked to cases of the Zika virus contracted in endemic areas.
Other drugmakers, including vaccines giant Sanofi, have Zika vaccine candidates in the pipeline, however their clinical trials are not expected to commence until 2017 at the earliest. Despite Inovio’s success so far, it could be years before their Zika vaccine completes all stages of the clinical trials process and is granted regulatory approval.