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Shingles Vaccine Antigen (Shingrix®)

Shingles is caused by the Varicella Zoster Virus (VZV), the same virus responsible for chicken pox. Shingles, also sometimes referred to as “herpes zoster”, is a painful and debilitating skin rash with inflammation, itching and chronic pain.  Although mortality is low, Shingles and its complications lead to significant morbidity for the elderly and patients with impaired immune systems. The Centers for Disease Control state that one in three people in the U.S. will contract shingles at some point in their lifetime. Current treatments are palliative to help with pain, itching and inflammation until a Shingles episode subsides. In 2006, Merck launched the first vaccine, Zostavax®, against VZV to prevent shingles. This live-attenuated virus vaccine has limited efficacy and is not recommended for patients who are older, immunocompromised, with AIDS, cancer, or have had organ transplants; the patients most at risk of getting shingles.

Dr. Abbas Vafai, while at the University of Colorado and University of Illinois, discovered a truncated form of glycoprotein E (gE protein) found on the surface of the Varicella Zoster Virus that could be used as a general vaccine antigen to avoid using the actual virus. After further development and filing patents to protect the gE antigen, RCT exclusively licensed the technology to GlaxoSmithKline (GSK) in 2000.  Utilizing the truncated gE antigen, GSK developed a new type of VZV vaccine with unique adjuvants which proved to be safer and more effective in preventing Shingles episodes across a broad patient population, including older patients and those who are immunocompromised. GSK performed numerous worldwide clinical trials in various at-risk patient populations with effective rates of prevention greater than 90% in Phase III clinical trials of those in good health. Post herpetic neuralgia (PHN), a debilitating complication of shingles, was reduced to near zero levels in these trials. GSK received regulatory approval of its shingles vaccine for those aged 50 years or older, marketed as Shingrix®, from the US FDA in October 2017.

After the US launch in December 2017, GSK’s cumulative sales of Shingrix® in the U.S. reached over $2 billion with more than 50 million Americans vaccinated.  The vaccine has been approved in more than 40 additional countries and is expected to prevent shingles in more than 100 million people world-wide. Additional clinical trials in multiple groups of immunocompromised patients, such as those undergoing organ transplants or with weakened immune systems due to disease or medical treatment, established the vaccine’s efficacy for these groups even if they were not 50 years of age and led to further marketing approvals for GSK in these younger populations. Real-world studies have confirmed the effectiveness of Shingrix® to prevent shingles in the general U.S. population. Recent studies indicate that Shingrix® lessens an individual’s burden of illness and may reduce the incidence of Alzheimer’s and Parkinson’s Diseases, as well as showing that Shingrix® protection against shingles is durable with effectiveness remaining at around 80% 11 years after administration. Due to the superior efficacy of Shingrix®, Zostavax® was removed from the U.S. market in 2019.

Inventors

Abbas Vafai, who is now Senior Scientific Advisor at Viro Research, LLC,  initiated and completed this invention at the University of Colorado Health Sciences Center in Denver and the University of Illinois College of Medicine at Rockford.  Dr. Vafai also held positions with the Centers for Disease Control and Prevention (CDC) in Atlanta.

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GlaxoSmithKline