GlaxoSmithKline shingles vaccine effective across older age groups

GlaxoSmithKline announced that its investigational, adjuvanted herpes zoster vaccine demonstrated efficacy in adults aged 50 years and older and did not decrease with age in a phase 3 trial.

“We are extremely encouraged that the results may point out a health benefit in the prevention of shingles,” Moncef Slaoui, MD, chairman of global vaccines at GlaxoSmithKline, said in a press release. “This disease can be painful and potentially debilitating for some people, and older people are particularly at risk.”

The ZOE-50 trial is a randomized, placebo-controlled study of 16,160 adults aged 50 years and older across North America, Europe, Latin America and Asia-Pacific. Participants in the treatment arm received intramuscular doses of HZ/su at 0 and 2 months.

Study results were presented at the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases in Copenhagen, Denmark, and published in the New England Journal of Medicine.

Analysis of the overall primary efficacy endpoint showed that a two-dose schedule of HZ/su reduced the risk for herpes zoster by 97.2% (95% CI, 93.7-99) compared with placebo. The HZ/su candidate vaccine is nonlive and combines gE, a viral protein that causes shingles, with an adjuvant system, AS01B, which is designed to enhance immunological response to gE, according to the release.

Vaccine efficacy was maintained across the various age groups: 96.6% in participants aged 50 to 59 years, 97.4% in participants aged 60 to 69 years and 97.9% in those aged 70 years or older.

According to the researchers, solicited injection site (81.5% vs. 11.9%) and systemic adverse reactions (66.1% vs. 29.5%) were more frequent in the HZ/su arm, with 9.5% of HZ/su recipients reporting grade 3 solicited injection site reactions compared with 0.4% of controls. The more frequently reported systemic reactions were muscle pain, fatigue and headache, of which 11.4% were graded severe in the HZ/su group vs. 2.4% in the placebo arm. Most of these adverse reactions occurred within 7 days of vaccination and lasted 1 to 3 days.

Additional trials to evaluate the efficacy of HZ/su are ongoing in people aged 70 years and older and in immunocompromised adults.

“These studies will provide additional information with respects to the safety of HZ/su and its ability to stimulate immune responses in specific populations,” according to the release. “They will also address the degree to which HZ/su can prevent complications of shingles such as chronic neuropathic pain.” – by David Jwanier

References:
Heineman TC, et al. Abstract LBOS0239a. Presented at: European Society of Clinical Microbiology and Infectious Diseases; April 25-28, 2015; Copenhagen, Denmark.
Lal H, et al. N Engl J Med. 2015;doi:10.1056/NEJMoa1501184.

Disclosure: One of the researchers reports personal fees and other support from GlaxoSmithKline outside the submitted work. The study was supported by GlaxoSmithKline. Please see the full study for a list of all other authors’ relevant financial disclosures.