The U.S. Food and Drug Administration on Monday for the first time granted clinical trial approval for an experimental Zika vaccine.
The vaccine, called GLS-5700, is manufactured by Inovio Pharmaceuticals of Plymouth Meeting, Pa. and GeneOne Life Science, of Seoul, South Korea. Earlier today, the companies announced they will begin within the next few weeks a Phase 1 trial with 40 healthy subjects to evaluate the safety, tolerability and immune response generated by the vaccine.
“We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers,” Inovio’s president and CEO, Dr. J. Joseph Kim, said in a prepared statement.
Interim trial results are expected later this year. Preclinical results have been promising: The vaccine “induced robust antibody and T cell responses in small and large animal models.”
The mosquito-driven Zika virus is associated with severe birth defects, like microcephaly, which is characterized by a significantly small head and brain developmental problems. The Centers for Disease Control and Prevention (CDC) announced last Friday that Puerto Rico is part of the Zika epidemic. The U.S. territory has more than 1,700 cases, including 191 in pregnant women.
Last week, the CDC reported three babies with Zika-linked birth defects were born in the U.S.
French drugmaker Sanofi is testing potential Zika vaccines on animals, and said it plans to begin clinical trials next year.
Still, these are the beginning stages of a Zika vaccine; it could be years of late-stage trial design and analysis before a vaccine reaches approval status.
Filed Under: Drug Discovery