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 journalArticle

36 Citations (Scopus)

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. Immunogenicity was evaluated using VZV interferon-gamma (IFN-γ) 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-γ ELISPOT geometric mean count (GMC) of spot-forming cells per 10 6 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 ∼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-γ 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.

Original languageEnglish (US)
Pages (from-to)904-910
Number of pages7
JournalVaccine
Volume30
Issue number5
DOIs
StatePublished - Jan 20 2012

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Herpes Zoster Vaccine
Human herpesvirus 3
Human Herpesvirus 3
immune response
vaccines
Safety
dosage
enzymes
Interferon-gamma
interferon-gamma
Immunity
Glycoproteins
placebos
glycoproteins
Placebos
Herpes Zoster
Enzymes
immunity
Antibodies
antibodies

Keywords

  • Herpes zoster
  • Immunogenicity
  • Safety
  • Vaccine

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

Vermeulen, J. N., Lange, J. M. A., Tyring, S. K., Peters, P. H., Nunez, M., Poland, G., ... 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

Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults ≥60 years of age. / Vermeulen, Joost N.; Lange, Joep M A; Tyring, Stephen K.; Peters, Patrick H.; Nunez, Margaret; Poland, Gregory; Levin, Myron J.; Freeman, Carrie; Chalikonda, Ira; Li, Jianjun; Smith, Jeffrey G.; Caulfield, Michael J.; Stek, Jon E.; Chan, Ivan S F; Vessey, Rupert; Schödel, Florian P.; Annunziato, Paula W.; Schlienger, Katia; Silber, Jeffrey L.

In: Vaccine, Vol. 30, No. 5, 20.01.2012, p. 904-910.

Research output: Contribution to journalArticle

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
Vermeulen, Joost N. ; Lange, Joep M A ; Tyring, Stephen K. ; Peters, Patrick H. ; Nunez, Margaret ; Poland, Gregory ; Levin, Myron J. ; Freeman, Carrie ; Chalikonda, Ira ; Li, Jianjun ; Smith, Jeffrey G. ; Caulfield, Michael J. ; Stek, Jon E. ; Chan, Ivan S F ; Vessey, Rupert ; Schödel, Florian P. ; Annunziato, Paula W. ; Schlienger, Katia ; Silber, Jeffrey L. / Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults ≥60 years of age. In: Vaccine. 2012 ; Vol. 30, No. 5. pp. 904-910.
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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.

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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. Immunogenicity was evaluated using VZV interferon-gamma (IFN-γ) 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-γ ELISPOT geometric mean count (GMC) of spot-forming cells per 10 6 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 ∼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-γ 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.

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