Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster

Palmetto Medical Research, Mount Pleasant, SC, United States.
Vaccine (Impact Factor: 3.62). 04/2010; 28(25):4204-9. DOI: 10.1016/j.vaccine.2010.04.003
Source: PubMed


Prior clinical studies of zoster vaccine enrolled subjects without a history of herpes zoster (HZ), so there are limited data on safety and immunogenicity in vaccinees with a prior history of HZ. This study was conducted to evaluate the safety and immunogenicity of zoster vaccine recipients who had a prior episode of HZ.
A total of 101 subjects > or = 50 years of age with a prior history of HZ were enrolled. They were stratified by number of years since their HZ (5 to 9 years and > or = 10 years, in an approximate 2:1 ratio), and randomized 1:1 to one of two vaccination groups. On day 1, Group I was administered zoster vaccine and Group II received placebo. At week 4, Group I received placebo and Group II received zoster vaccine. Subjects were followed for adverse experiences (AEs), exposure to varicella or HZ, and development of any varicella/varicella-like or HZ/HZ-like rashes, for 28 days after each injection. Blood samples were obtained prior to study injection on day 1 and week 4, and at week 8. Serum was assessed for varicella-zoster virus (VZV) antibody concentration by glycoprotein enzyme-linked immunosorbent assay.
No serious AEs were reported within the 28-day safety follow-up period following any vaccination. Although a higher percentage of subjects reported injection-site AEs after receiving zoster vaccine than did placebo recipients, the proportion of subjects reporting systemic clinical AEs was similar in both groups. Zoster vaccine induced a VZV antibody response at 4 weeks post-vaccination. The estimated geometric mean titer (GMT) ratio (vaccine/placebo) was 2.07 (95% CI: 1.48, 2.88). The geometric mean fold-rise (GMFR) from prevaccination to week 4 post-vaccination was 2.1 in zoster vaccine recipients, versus 1.0 in placebo recipients.
In HZ history-positive adults > or = 50 years of age, zoster vaccine: (1) was well tolerated; and (2) significantly boosted the level of VZV antibody from baseline to 4 weeks post-vaccination as measured by GMT and GMFR. These data support the Advisory Committee on Immunization Practices' recommendation for routine zoster vaccination for all immunocompetent persons >/=60 years of age irrespective of HZ history.

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    • "US Center for Disease Control and Prevention (US CDC) recommended to inoculate herpes zoster vaccine regardless of past history of herpes zoster, because there is risk of recurrence although it is rare, because it is not clear up to when the incidence risk is reduced, and because there is possibility that the patient does not know about the past disease history. In a study which evaluated the safety and the immunogenicity of ZOSTAVAX on those who were over 50 in 2010, there were no major reactions when ZOSTAVAX was inoculated to those who had herpes zoster in the past, and other local or systemic reactions were similar to the results of SPS [17]. Additionally, the antibody titer measured 4 weeks after the vaccination, those who had ZOSTAVAX showed 2.1 times higher before the vaccination and 2.07 times higher than those who had placebo. "
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