Comparison of the Levels of Immunogenicity and Safety of Zostavax in Adults 50 to 59 Years Old and in Adults 60 Years Old or Older

Abstract

Zostavax has been shown to be efficacious in the prevention of herpes zoster and generally well tolerated in clinical trials among subjects 60 years old or older. This prespecified combined analysis from two studies compares the levels of immunogenicity and safety of Zostavax in subjects 50 to 59 years old versus those in subjects >60 years old. Varicella-zoster virus (VZV) antibody (Ab) titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and 4 weeks postvaccination. Noninferiority was evaluated by estimated geometric mean severalfold rise (GMFR) ratio (50 to 59 years old/>60 years old) and two-sided 95% confidence interval (CI). Success was defined by a lower bound (LB) of the 95% CI of the GMFR ratio of >0.67. Acceptability of postvaccination VZV Ab was defined by an LB of the 95% CI of the GMFR of >1.4. Safety data were recorded for 28 days postvaccination by standardized vaccination report card. The estimated GMFRs from baseline to 4 weeks postvaccination were 2.6 (95% CI, 2.4, 2.9) in subjects 50 to 59 years old and 2.3 (95% CI, 2.1, 2.4) in subjects >60 years old. The estimated GMFR ratio (50 to 59 years old/>60 years old) was 1.13 (95% CI, 1.02, 1.25). No serious Zostavax-related adverse experiences were reported. After a dose of Zostavax, the GMFR of the VZV Ab response in subjects 50 to 59 years old was noninferior to that in subjects >60 years old. The VZV Ab response was acceptable in both age groups. Zostavax was generally well tolerated in both age groups.Herpes zoster (HZ), also known as shingles, is a manifestation of reactivation of varicella-zoster virus (VZV), which, as a primary infection, is responsible for chickenpox (varicella). The incidence and severity of HZ increase with age (14,26,28). In the United States, Canada, and Europe, the overall annual incidence of HZ is consistently estimated to be 3 to 4 per 1,000 population (1,7,8,11,15,18,22). The annual risk of developing HZ increases markedly around 50 years of age and rises sharply afterwards, up to 1% per year among those over 75 years of age. The lifetime risk of HZ is estimated to range from 10% to 30% in the general population, with estimates closer to 30% in recent studies (2,4,5,8,14,15), and is as high as 50% in individuals reaching 85 years of age (14,26,32).Zostavax (live zoster vaccine), a vaccine for the prevention of HZ (shingles) in individuals Ն60 years of age, has been recently licensed in the United States (3, 13, 30) and was subsequently licensed by the European Union for the prevention of HZ and HZ-related postherpetic neuralgia (PHN) in individuals Ն50 years of age (9). As demonstrated by the Shingles Prevention Study (SPS), Zostavax has been shown to reduce the incidence of HZ and PHN in adults Ն60 years of age and to lessen acute and chronic pain associated with HZ, presumably through boosting of VZV-specific immune responses (19,24). The SPS demonstrated that the VZV antibody (Ab) response correlated with vaccine effect in preventing HZ (19).Two recent studies of Zostavax enrolled su...

Perspectives on Vaccines Against Varicella-Zoster Virus Infections

“…Currently, one dose is recommended for individuals over 60 years of age who are relatively healthy. A small study in 1,122 subjects aged 50–59 at vaccination indicated that it was immunogenic and safe (Sutradhar et al 2009). It might therefore make sense, for example, to vaccinate younger individuals who are projected to have solid organ transplants in the near future.…”

Schutz vor Zoster

“…Die Wirksamkeit und Sicherheit des Zoster-Impfstoffs bei Menschen im Alter von 50-59 Jahren ist durch weitere klinische Studien belegt [20]. VZV-seronegative Erwachsene und Menschen, die bereits Zoster durchgemacht haben, tolerieren den Impfstoff gut und reagieren mit einer entsprechenden Immunantwort [14,16].…”

Zoster-Vakzine

“…So wurde geprüft, wie Personen im Alter von 50 -59 auf die Zosterimpfung reagieren. Erwartungsgemäß erwies sich die Vakzine auch in dieser Altersgruppe als immunogen und sicher [19]. Außerdem wurden Untersuchungen über Verträglichkeit und Immunogenität des Zosterimpfstoffs bei VZV-seronegativen Erwachsenen durchgeführt, deren Anteil in Deutschland in der Altersgruppe der über 40-Jährigen weniger als 1% beträgt [20].…”