Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults ?0 years of age

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• 作者：Joost N. Vermeulen^a ; Joep M.A. Lange^a ; Stephen K. Tyring^b ; Patrick H. Peters^c ; Margaret Nunez^d ; Gregory Poland^e ; Myron J. Levin^f ; Carrie Freeman^g ; Ira Chalikonda^g ; Jianjun Li^g ; ¹ ; Jeffrey G. Smith^g ; Michael J. Caulfield^g ; ² ; Jon E. Stek^g ; Ivan S.F. Chan^g ; Rupert Vessey^g ; Florian P. Sch&ouml ; del^g ; ³ ; Paula W. Annunziato^g ; ^{paula_annunziato@merck.com} ; Katia Schlienger^g ; ⁴ ; Jeffrey L. Silber^g
• 关键词：Herpes zoster ; Vaccine ; Safety ; Immunogenicity
• 刊名：Vaccine
• 出版年：2012
• 出版时间：20 January 2012
• 年：2012
• 卷：30
• 期：5
• 页码：904-910
• 全文大小：261 K

文摘

lass=""h4"">Background

Incidence and severity of herpes zoster (HZ) and postherpetic neuralgia increase with age, associated with age-related decrease in immunity to varicella-zoster virus (VZV). One dose of zoster vaccine (ZV) has demonstrated substantial protection against HZ; this study examined impact of a second dose of ZV.

lass=""h4"">Methods

Randomized, double-blind, multicenter study with 210 subjects ?0 years old compared immunity and safety profiles after one and two doses of ZV, separated by 6 weeks, vs. placebo. Immunogenicity was evaluated using VZV interferon-gamma (IFN-¦Ã) enzyme-linked immunospot (ELISPOT) assay and VZV glycoprotein enzyme-linked immunosorbent antibody (gpELISA) assay. Adverse experiences (AEs) were recorded on a standardized Vaccination Report Card.

lass=""h4"">Results

No serious vaccine-related AEs occurred. VZV IFN-¦Ã ELISPOT geometric mean count (GMC) of spot-forming cells per 10⁶ peripheral blood mononuclear cells increased in the ZV group from 16.9 prevaccination to 49.5 and 32.8 at 2 and 6 weeks postdose 1, respectively. Two weeks, 6 weeks and 6 months postdose 2, GMC was 44.3, 42.9, and 36.5, respectively. GMC in the placebo group did not change during the study. The peak ELISPOT response occurred ? weeks after each ZV dose. The gpELISA geometric mean titers (GMTs) in the ZV group were higher than in the placebo group at 6 weeks after each dose. Correlation between the IFN-¦Ã ELISPOT and gpELISA assays was poor.

lass=""h4"">Conclusions

ZV was generally well-tolerated and immunogenic in adults ?0 years old. A second dose of ZV was generally safe, but did not boost VZV-specific immunity beyond levels achieved postdose 1.