The trial showed that Inovio’s DNA-based vaccine triggered high levels of binding antibodies in all 40 participants. The team also reported observing a strong neutralizing antibody and T-cell immune response in vaccinated participants.
The company’s study was published in the New England Journal of Medicine.
In the Phase I study, 20 participants received the vaccine, GLS-5700, in a 1 milligram dose and 20 people received it in a 2 milligram dose. The Zika virus vaccine was delivered via intradermal injections using Inovio’s Cellectra device.
After a three-dose vaccination regimen, the vaccine induced binding antibodies in all participants. In 95% of participants the investigational product triggered binding antibodies after just two doses.
Serum samples from people who received the vaccines were then transferred to mice. The researchers found that in more than 90% of animals, the serum samples helped protect them when exposed to a lethal dose of the Zika virus.
“Inovio is the first organization in the world to report on positive Zika vaccine data from a clinical study. We’ve posted similar encouraging HIV, Ebola and MERS vaccine data arising from our product development engine of DNA-immunotherapies and vaccines. Results from this published study demonstrate that all human subjects responded to the vaccine and that the immune responses have the ability to confer protection in challenge models,” president & CEO Dr. J. Joseph Kim said in prepared remarks.
“A second phase 1 study, now fully enrolled in Puerto Rico, is designed with a placebo control to explore a potential trend towards clinical efficacy. Inovio is proud to be a pioneer of Zika vaccine development, and the first to generate positive human data that clearly supports advancement of DNA technology and our vaccine candidate.”
Inovio is developing its Zika virus vaccine with GeneOne Life Science and academic collaborators in the U.S. and Canada.
The World Health Organization estimates that at least two billion people are directly at risk for infection by the Zika virus, but there is no approved therapy or vaccine.
INO shares were up 8% in pre-market activity today.