Vaccine efficacy 97.2 percent overall in phase 3 trial among adults aged 50 years and older
WEDNESDAY, April 29, 2015 (HealthDay News) — A subunit vaccine containing varicella-zoster virus glycoprotein E and the AS01B adjuvant system (HZ/su) is efficacious against herpes zoster infection in older adults, according to a study published online April 28 in the New England Journal of Medicine. The research was published to coincide with the European Congress of Clinical Microbiology and Infectious Diseases, held from April 25 to 28 in Copenhagen, Denmark.
Himal Lal, M.D., from GSK Vaccines in King of Prussia, Pa., and colleagues conducted a randomized, placebo-controlled phase 3 trial in 18 countries to examine the efficacy and safety of HZ/su in older adults who were separated according to age group (50 to 59, 60 to 69, and ≥70 years). A total of 15,411 participants were randomized to receive two intramuscular doses of the vaccine (7,698 participants) or placebo (7,713 participants) two months apart.
The researchers confirmed herpes zoster infection in six participants in the vaccine group and 210 in the placebo group during a mean follow-up of 3.2 years (incidence rate, 0.3 versus 9.1 per 1,000 person years). Vaccine efficacy was 97.2 percent overall, and varied from 96.6 to 97.9 percent for all age groups. The vaccine group had more frequent solicited injection-site and systemic reactions within seven days after vaccination. Grade 3 solicited or unsolicited symptoms were reported in 17.0 and 3.2 percent of vaccine and placebo recipients, respectively.
“The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older,” the authors write. “Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups.”
The study was funded by GlaxoSmithKline Biologicals, which is developing HZ/su.
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