Experimental Zika vaccine to be tested on humans
A United States pharmaceutical company and an international DNA vaccine developer have been given the green light to start phase one of a Zika vaccine human trial.
In preclinical testing, the synthetic Zika DNA vaccine (GLS-5700) developed by Inovio Pharmaceuticals and GeneOne Life Science induced robust antibody and T cell responses in small and large animal models, demonstrating the product’s potential to prevent infection.
The human trial will be conducted in the coming weeks with 40 healthy subjects, the companies say, and will evaluate the safety, tolerability and immunogenicity of GLS-5700.
“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.
“We plan to dose our first subjects in the next weeks and expect to report phase one interim results later this year.”
Kim’s counterpart at GeneOne Life Science, Young K. Park, said it was an honour for his company to help usher in 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,” said the head of the Seoul, South Korea-based company.
Inovio and GeneOne are developing the Zika vaccine with academic collaborators from the US and Canada with whom they have previously collaborated to advance Inovio’s Ebola and MERS vaccines into clinical development.
As of May, 58 countries and territories have reported continuing mosquito-borne transmission of the Zika virus. Because the Aedes species of mosquitoes that spreads Zika virus is found throughout the world, there is concern that Zika will continue to spread to new countries and regions.
Zika can also be sexually transmitted.
The most common symptoms of the virus are fever, rash, joint pain, and conjunctivitis. More seriously, it has been linked to a severe birth defect called microcephaly – a rare condition marked by an abnormally small head and incomplete brain development – which arises from infection during pregnancy.
Zika is also associated with Guillain-Barré syndrome, which causes muscle weakness of the limbs and in severe cases may cause almost total paralysis, including the inability to breath. Recent reports suggest Zika may also be linked to other neurological abnormalities.