Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >= 60 years of age

Joost N. Vermeulen; Joep M. A. Lange; Stephen K. Tyring; Patrick H. Peters; Margaret Nunez; Gregory Poland; Myron J. Levin; Carrie Freeman; Ira Chalikonda; Jianjun Li; Jeffrey G. Smith; Michael J. Caulfield; Jon E. Stek; Ivan S. F. Chan; Rupert Vessey; Florian P. Schödel; Paula W. Annunziato; Katia Schlienger; Jeffrey L. Silber

doi:10.1016/j.vaccine.2011.11.096

Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >= 60 years of age

Joost N. Vermeulen
, Joep M. A. Lange
, Stephen K. Tyring
, Patrick H. Peters
, Margaret Nunez
, Gregory Poland
, Myron J. Levin
, Carrie Freeman
, Ira Chalikonda
, Jianjun Li
, Jeffrey G. Smith
, Michael J. Caulfield
, Jon E. Stek
, Ivan S. F. Chan
, Rupert Vessey
, Florian P. Schödel
, Paula W. Annunziato
, Katia Schlienger
, Jeffrey L. Silber

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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. Methods: Randomized, double-blind, multicenter study with 210 subjects >= 60 years old compared immunity and safety profiles after one and two doses of ZV, separated by 6 weeks, vs. placebo. lmmunogenicity was evaluated using VZV interferon-gamma (IFN-gamma) 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. Results: No serious vaccine-related AEs occurred. VZV IFN-gamma 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 similar to 2 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-gamma ELISPOT and gpELISA assays was poor. Conclusions: ZV was generally well-tolerated and immunogenic in adults >= 60 years old. A second dose of ZV was generally safe, but did not boost VZV-specific immunity beyond levels achieved postdose 1. (C) 2011 Elsevier Ltd. All rights reserved

Original language	English
Pages (from-to)	904-910
Journal	Vaccine
Volume	30
Issue number	5
DOIs	https://doi.org/10.1016/j.vaccine.2011.11.096
Publication status	Published - 2012

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

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10.1016/j.vaccine.2011.11.096

Cite this

Vermeulen, J. N., Lange, J. M. A., Tyring, S. K., Peters, P. H., Nunez, M., Poland, G., Levin, M. J., Freeman, C., Chalikonda, I., Li, J., Smith, J. G., Caulfield, M. J., Stek, J. E., Chan, I. S. F., Vessey, R., Schödel, F. P., Annunziato, P. W., Schlienger, K., & Silber, J. L. (2012). Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >= 60 years of age. Vaccine, 30(5), 904-910. https://doi.org/10.1016/j.vaccine.2011.11.096

@article{4a299aef43694ac0949dee5a0f0fb3fe,

title = "Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >= 60 years of age",

abstract = "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. Methods: Randomized, double-blind, multicenter study with 210 subjects >= 60 years old compared immunity and safety profiles after one and two doses of ZV, separated by 6 weeks, vs. placebo. lmmunogenicity was evaluated using VZV interferon-gamma (IFN-gamma) 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. Results: No serious vaccine-related AEs occurred. VZV IFN-gamma 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 similar to 2 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-gamma ELISPOT and gpELISA assays was poor. Conclusions: ZV was generally well-tolerated and immunogenic in adults >= 60 years old. A second dose of ZV was generally safe, but did not boost VZV-specific immunity beyond levels achieved postdose 1. (C) 2011 Elsevier Ltd. All rights reserved",

author = "Vermeulen, \{Joost N.\} and Lange, \{Joep M. A.\} and Tyring, \{Stephen K.\} and Peters, \{Patrick H.\} and Margaret Nunez and Gregory Poland and Levin, \{Myron J.\} and Carrie Freeman and Ira Chalikonda and Jianjun Li and Smith, \{Jeffrey G.\} and Caulfield, \{Michael J.\} and Stek, \{Jon E.\} and Chan, \{Ivan S. F.\} and Rupert Vessey and Sch{\"o}del, \{Florian P.\} and Annunziato, \{Paula W.\} and Katia Schlienger and Silber, \{Jeffrey L.\}",

year = "2012",

doi = "10.1016/j.vaccine.2011.11.096",

language = "English",

volume = "30",

pages = "904--910",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier BV",

number = "5",

}

Vermeulen, JN, Lange, JMA, Tyring, SK, Peters, PH, Nunez, M, Poland, G, Levin, MJ, Freeman, C, Chalikonda, I, Li, J, Smith, JG, Caulfield, MJ, Stek, JE, Chan, ISF, Vessey, R, Schödel, FP, Annunziato, PW, Schlienger, K & Silber, JL 2012, 'Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >= 60 years of age', Vaccine, vol. 30, no. 5, pp. 904-910. https://doi.org/10.1016/j.vaccine.2011.11.096

TY - JOUR

T1 - Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >= 60 years of age

AU - Vermeulen, Joost N.

AU - Lange, Joep M. A.

AU - Tyring, Stephen K.

AU - Peters, Patrick H.

AU - Nunez, Margaret

AU - Poland, Gregory

AU - Levin, Myron J.

AU - Freeman, Carrie

AU - Chalikonda, Ira

AU - Li, Jianjun

AU - Smith, Jeffrey G.

AU - Caulfield, Michael J.

AU - Stek, Jon E.

AU - Chan, Ivan S. F.

AU - Vessey, Rupert

AU - Schödel, Florian P.

AU - Annunziato, Paula W.

AU - Schlienger, Katia

AU - Silber, Jeffrey L.

PY - 2012

Y1 - 2012

N2 - 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. Methods: Randomized, double-blind, multicenter study with 210 subjects >= 60 years old compared immunity and safety profiles after one and two doses of ZV, separated by 6 weeks, vs. placebo. lmmunogenicity was evaluated using VZV interferon-gamma (IFN-gamma) 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. Results: No serious vaccine-related AEs occurred. VZV IFN-gamma 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 similar to 2 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-gamma ELISPOT and gpELISA assays was poor. Conclusions: ZV was generally well-tolerated and immunogenic in adults >= 60 years old. A second dose of ZV was generally safe, but did not boost VZV-specific immunity beyond levels achieved postdose 1. (C) 2011 Elsevier Ltd. All rights reserved

AB - 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. Methods: Randomized, double-blind, multicenter study with 210 subjects >= 60 years old compared immunity and safety profiles after one and two doses of ZV, separated by 6 weeks, vs. placebo. lmmunogenicity was evaluated using VZV interferon-gamma (IFN-gamma) 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. Results: No serious vaccine-related AEs occurred. VZV IFN-gamma 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 similar to 2 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-gamma ELISPOT and gpELISA assays was poor. Conclusions: ZV was generally well-tolerated and immunogenic in adults >= 60 years old. A second dose of ZV was generally safe, but did not boost VZV-specific immunity beyond levels achieved postdose 1. (C) 2011 Elsevier Ltd. All rights reserved

U2 - 10.1016/j.vaccine.2011.11.096

DO - 10.1016/j.vaccine.2011.11.096

M3 - Article

C2 - 22154769

SN - 0264-410X

VL - 30

SP - 904

EP - 910

JO - Vaccine

JF - Vaccine

IS - 5

ER -

Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults >= 60 years of age

Abstract

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