Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster.
ABSTRACT 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.
[Show abstract] [Hide abstract]
ABSTRACT: PurposeWhether patients with inflammatory bowel disease (IBD) exhibit a high risk of developing varicella zoster virus (VZV) infection in Asian populations remains inconclusive. We investigated the causal relationship between two diseases by analysing the Taiwan National Health Insurance Research Database.Patients and methodsBased on a universal insurance claims database, we enrolled 7055 IBD patients and 28,220 age- and sex-matched controls. We calculated the hazard ratios (HRs) and 95% confidence intervals (CIs) of the herpes zoster virus (HZV) in the IBD and comparison cohorts, using the Cox proportional hazards regression model.ResultsPatients with IBD exhibited significantly higher risk of the HZV compared with the controls (adjusted HRs, 1.42; 95% CI, 1.27–1.60). Further analysis indicated that male patients (adjusted HRs, 1.61; 95% CI, 1.35–1.92), aged 35–44 (adjusted HRs, 1.47; 95% CI, 1.08–2.01) and aged 65 years and older (adjusted HRs, 1.47; 95% CI, 1.19–1.80), and patients without comorbidities (adjusted HRs, 1.44; 95% CI, 1.26–1.66), exhibited excessive risks of VZV infection. Moreover, our findings show that the overall risk of developing VZV infection increased risk from 1.03 (95% CI, 0.90–1.18) (≤ 2 visits) to 9.76 (95% CI, 7.60–12.5) (> 4 visits), which correlates positively with the frequency of medical visits (trend test p < 0.0001).Conclusion Patients with IBD, particularly men aged 35–44/65 years and over, and patients without comorbidities, are associated with a long-term risk of VZV infection. The excessive risk of VZV infection should be considered for administering vaccines to IBD patients.International Journal of Clinical Practice 10/2014; 69(2). DOI:10.1111/ijcp.12508 · 2.54 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: The age-associated increased susceptibility to infectious disease would suggest that vaccination should be a route to promote healthy aging and keep our seniors autonomous and independent. While vaccination represents a cost-effective and efficient strategy at community level, the ability of the immune system to mount a protective immune response is still unpredictable at the level of the individual. Thus, at a similar age, some individuals, including the elderly, might still be 'good' responders while some other, even younger, would definitely fail to mount a protective response. In this review, the current burden of vaccine-preventable diseases in the aging and aged population will be detailed with the aim to identify the ideal vaccine candidates over the age of 50 years. This article will conclude with potential strategies to reduce, as best as possible, this burden and the imperative need to overcome barriers in extending current vaccine coverage towards to a lifelong vaccine schedule.Drugs & Aging 06/2014; DOI:10.1007/s40266-014-0193-1 · 2.50 Impact Factor
[Show abstract] [Hide abstract]
ABSTRACT: Background. After completion of the Shingles Prevention Study (SPS; VA Cooperative Studies Program #403), SPS placebo recipients were offered investigational zoster vaccine without charge. This provided an opportunity to determine the relative safety of zoster vaccine in older adults following documented herpes zoster (HZ).Methods. SPS placebo recipients who elected to receive zoster vaccine (13,681) were followed for serious adverse events (SAE) for 28 days post-vaccination. In contrast to the SPS, a prior episode of HZ was not a contraindication to receiving zoster vaccine. The SPS placebo recipients who received zoster vaccine included 420 who had developed documented HZ during the SPS.Results. The mean interval between the onset of HZ and receipt of zoster vaccine in the 420 recipients with prior HZ was 3.61 years (median 3.77 years; range 3-85 months); the interval was less than 5 years in approximately 80%. The proportion of vaccinated SPS placebo recipients with prior HZ who developed one or more SAE (0.95%) was not significantly different from that of vaccinated placebo recipients with no prior history of HZ (0.66%), and the distribution of SAE in the two groups was comparable.Conclusions. These results demonstrate that the general safety of zoster vaccine in older persons is not altered by a recent history of documented HZ, supporting the safety aspect of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommendation to administer zoster vaccine to all persons >60 years of age with no contraindications, regardless of a prior history of HZ.The Journal of Infectious Diseases 04/2013; DOI:10.1093/infdis/jit182 · 5.78 Impact Factor