The U.S. Food and Drug Administration (FDA) has approved the first clinical trial of a Zika vaccine involving humans. Inovio Pharmaceuticals of Pennsylvania and GeneOne Life Science of South Korea joined forces to develop the drug named GLS-5700 and researchers will be able to announce the results of the test on human subjects later this year. Just five months ago, the World Health Organization (WHO) was declaring Zika a global public health emergency.
GeneOne and Inovio said Monday they will conduct in a few weeks a phase I study with 40 healthy subjects to find out how safe the vaccine is and how well the human body tolerates it. If the clinical trial happens to be successful, the researchers will then be able to test the drug on people infected with the Zika virus, which will determine if GLS-5700 works to fight the disease.
Inovio said the experimental Zika vaccine caused high antibody response on large animals during preclinical testing, which means the drug proved its potential to prevent infection from the virus that has been linked to microcephaly and other types of birth defects when pregnant women contract it.
Zika is also linked to Guillain-Barré syndrome, which leads to muscle weakness of the limbs and the worst cases include almost total paralysis, and patients could end up unable to breathe. Recent research suggests the virus may be associated with other types of neurological issues.
“We are proud to have attained the approval to initiate the first Zika vaccine study in human volunteers,” expressed Inovio CEO J. Joseph Kim in a statement, according to the company’s website. “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.”
There already are vaccines under development for Dengue and West Nile, mosquito-spread flavivirus similar to Zika. Flavivirus is a family of viruses that also includes yellow fever.
These initial advances have helped scientists come up with a promising Zika vaccine less than a semester after the WHO admitted the disease was spreading at alarming rates.
Academic contributors from the United States and Canada who have helped advance Inovio’s Ebola and MERS vaccines into clinical development are collaborating with GeneOne and Inovio in developing the Zika vaccine.
Based in Seoul, GeneOne Life Science studies and develops DNA vaccines for prevention and treatment of incurable diseases beyond South Korea. The company has a wholly-owned manufacturing subsidiary in Texas called VGXI, Inc., which claims to be the world’s largest pure-play cGMP DNA plasmid manufacturing, according to a press release available on Inovio’s website. The Texas subsidiary manufactured the Zika vaccine.
U.S. regulators have been taking action to fight Zika beyond American soil
Health officials fear that Zika will continue to spread to new regions because the Aedes species of mosquitoes that transmit it is found throughout the world. The virus was first detected in Uganda and has quickly spread through Hawaii, South America, Central America, and the Caribbean.
The FDA in May approved the emergency use of a Zika test from the Hamburg-based Altona Diagnostics. A separate company, Hologic Inc., said its diagnostic test designed to detect snippets of the Zika virus in samples of human blood had also received FDA approval for the product to be used in emergency cases in the United States and Puerto Rico, according to a report by The Washington Post.