Inovio Pharmaceuticals and GeneOne Life Science have received FDA approval to initiate a phase 1 human trial to evaluate Inovio’s Zika DNA vaccine GLS-5700. In preclinical testing, the synthetic vaccine induced antibody and T-cell responses in small and large animal models.
The open-label, dose-ranging study will evaluate the safety, tolerability, and immunogenicity of GLS-5700 administered intradermally with Cellectra, Inovio’s proprietary DNA delivery device, in 40 healthy subjects.
Inovio and GeneOne are developing GLS-5700 with academic collaborators in the United States and Canada, with whom they previously collaborated to advance Inovio’s Ebola and Middle East respiratory syndrome (MERS) vaccines into clinical development.
First identified in Uganda, Zika virus subsequently spread to equatorial Asia. During the past two years, the virus has continued to spread through the South Pacific, including Hawaii, and to South America, Central America, and the Caribbean. Zika virus is a flavivirus, a family of viruses that includes yellow fever, dengue, and West Nile virus, which are introduced to people through mosquito bites. Because the Aedes species of mosquitoes that spreads Zika virus is found throughout the world, health officials are concerned that Zika will continue to spread to new countries and regions. The virus can also be sexually transmitted.
The most common symptoms of Zika virus infection include fever, rash, joint pain, and conjunctivitis. More seriously, Zika has been linked to microcephaly in newborns, which can result from infection during pregnancy. Microcephaly is a rare condition marked by an abnormally small head and incomplete brain development. The Zika virus has also been associated with Guillain–Barré syndrome in adults, and it may cause other neurologic abnormalities.
No vaccine or therapy currently exists for Zika virus infection.
Source: Inovio Pharmaceuticals; June 20, 2016.