New Trial to Evaluate Investigational Hepatitis C Vaccine
If proven effective, GLS-6150 could be the first vaccine to protect against hepatitis C virus infection.
Although new treatments have made hepatitis C virus (HCV) curable, there is currently no effective vaccine on the market to protect against infection.
In an effort to develop the first successful HCV vaccine, Inovio Pharmaceuticals and its Korean partner GeneOne Life Science announced they have dosed the first patient in a phase 1 study evaluating an investigational vaccine against HCV infection.
The open-label phase 1 study of the experimental vaccine, GLS-6150, will evaluate 24 participants who have sustained a virologic response following treatment for HCV and an additional 8 healthy participants in the control group. Participants will receive 1 of the 2 doses of vaccine, 1 or 2 mg administered intra-dermally and followed by electroporation with Cellectra-3P device. Participants will either be vaccinated in a 3-dose series at 0, 4, and 12 weeks or a 2-dose series at 0 and 8 weeks, followed by a booster dose at 6 months. The final study visit will be 4 weeks after the 6-month booster vaccination.
If proven effective, GLS-6150 could be the first vaccine to protect against HCV.
Although advancements in HCV therapies have yielded better treatment outcomes, the drugs come with several drawbacks, including high cost and the inability to prevent reinfection. An HCV vaccine could help dramatically reduce transmission of the virus and prevent widespread infection, especially in high-risk populations, such as intravenous drug users.
Vaccines are currently approved for hepatitis A and hepatitis B, but HCV’s variability has made it challenging for an effective vaccine to be developed. HCV occurs in at least 6 genetically distinct forms with multiple strains, with about 50 subtypes that have been identified to date.
“The key to a successful hepatitis C vaccine will be its ability to activate the body’s immune system to prevent or treat infection by a virus with multiple or ever-changing strains,” J. Joseph Kim, PhD, president and CEO of Inovio, said in a statement. “Inovio’s DNA-based technology platform is uniquely positioned to address this challenge and it has been optimizing over the last several years in demonstrating strong in vivo immune responses against very tough-to-treat viruses like HIV, Zika, and flu.”
According to Inovio, synthetic DNA vaccines have an advantage over inactivated or attenuated virus products because they are not limited to 1 specific strain of the virus.
The company expects data from the phase 1 trial to be available in 2019.
Inovio and Korean Partner Dose 1st Subject In Trial to Develop World’s First Vaccine to Prevent Hepatitis C Infection [news release]. Inovio’s website. http://ir.inovio.com/news-and-media/news/press-release-details/2018/Inovio-and-Korean-Partner-Dose-1st-Subject-In-Trial-to-Develop-Worlds-First-Vaccine-to-Prevent-Hepatitis-C-Infection/default.aspx. Accessed September 5, 2018.