Inovio Pharmaceuticals has reported positive safety and immune response results from a first-in-man, multi-centre Phase I trial (ZIKA-001) of its DNA-based vaccine (GLS-5700) for the treatment of Zika virus.
A total of 40 participants were included in the trial in two groups and received GLS-5700 in a 1mg or 2mg dose.
The vaccine was administered in 0.1ml intradermal injections using the company’s Cellectra 3P skin vaccine device.
It is reported that the vaccine induced high levels of binding antibodies in 100% of participants after a three-dose vaccination regimen and in 95% after two doses of vaccine.
Additionally, neutralising antibodies were observed in more than 95% of the serum samples that were assayed on neuronal-cell targets.
Researchers and collaborators from the company have published the trial results in the New England Journal of Medicine in the article titled: ‘Safety and Immunogenicity of an Anti-Zika Virus DNA Vaccine’.
Inovio president and CEO Dr Joseph Kim said: “Inovio is the first organisation 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. A second Phase I 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.”
The company’s second fully enrolled, placebo-controlled, double-blind trial involves 160 healthy adult volunteers and is designed to evaluate the safety, tolerability and immunogenicity of GLS-5700 in dengue virus-positive individuals.
According to the company, it will also evaluate differences in Zika infection rates in participants given either placebo or vaccine as part of an exploratory efficacy endpoint.
GLS-5700 is being developed by Inovio in partnership with GeneOne Life Science and academic collaborators from the US and Canada who are also collaborating to advance clinical development of the company’s Ebola and MERS vaccines.