Long-term persistence of zoster vaccine efficacy

Vicki A. Morrison; Gary R. Johnson; Kenneth E. Schmader; Myron J. Levin; Jane H. Zhang; David J. Looney; Robert Betts; Larry Gelb; John C. Guatelli; Ruth Harbecke; Connie Pachucki; Susan Keay; Barbara Menzies; Marie R. Griffin; Carol A. Kauffman; Adriana Marques; John Toney; Kathy Boardman; Shu Chih Su; Xiaoming Li; Ivan S.F. Chan; Janie Parrino; Paula Annunziato; Michael N. Oxman; L. E. Davis; C. A. Kauffman; S. K. Keay; S. E. Straus; N. E. Soto; P. Brunell; J. W. Gnann; R. Serrao; D. J. Cotton; R. P. Goodman; R. D. Arbeit; C. T. Pachucki; M. J. Levin; K. E. Schmader; W. A. Keitel; R. N. Greenberg; V. A. Morrison; P. F. Wright; M. R. Griffin; M. S. Simberkoff; S. S. Yeh; Z. Lobo; M. Holodniy; J. Loutit; R. F. Betts; L. D. Gelb; G. E. Crawford; J. Guatelli; P. A. Brooks; D. J. Looney; K. M. Neuzil; J. F. Toney; C. A. Kauffman; S. K. Keay; C. T. Pachucki; M. J. Levin; K. E. Schmader; V. A. Morrison; P. F. Wright; M. R. Griffin; R. F. Betts; L. D. Gelb; J. Guatelli; D. J. Looney; K. M. Neuzil; B. Menzies; J. F. Toney

doi:10.1093/cid/ciu918

Long-term persistence of zoster vaccine efficacy

Vicki A. Morrison, Gary R. Johnson, Kenneth E. Schmader, Myron J. Levin, Jane H. Zhang, David J. Looney, Robert Betts, Larry Gelb, John C. Guatelli, Ruth Harbecke, Connie Pachucki, Susan Keay, Barbara Menzies, Marie R. Griffin, Carol A. Kauffman, Adriana Marques, John Toney, Kathy Boardman, Shu Chih Su, Xiaoming LiIvan S.F. Chan, Janie Parrino, Paula Annunziato, Michael N. Oxman, L. E. Davis, C. A. Kauffman, S. K. Keay, S. E. Straus, N. E. Soto, P. Brunell, J. W. Gnann, R. Serrao, D. J. Cotton, R. P. Goodman, R. D. Arbeit, C. T. Pachucki, M. J. Levin, K. E. Schmader, W. A. Keitel, R. N. Greenberg, V. A. Morrison, P. F. Wright, M. R. Griffin, M. S. Simberkoff, S. S. Yeh, Z. Lobo, M. Holodniy, J. Loutit, R. F. Betts, L. D. Gelb, G. E. Crawford, J. Guatelli, P. A. Brooks, D. J. Looney, K. M. Neuzil, J. F. Toney, C. A. Kauffman, S. K. Keay, C. T. Pachucki, M. J. Levin, K. E. Schmader, V. A. Morrison, P. F. Wright, M. R. Griffin, R. F. Betts, L. D. Gelb, J. Guatelli, D. J. Looney, K. M. Neuzil, B. Menzies, J. F. Toney

Internal Medicine

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

255 Scopus citations

Abstract

Background. The Shingles Prevention Study (SPS) demonstrated zoster vaccine efficacy through 4 years postvaccination. A Short-Term Persistence Substudy (STPS) demonstrated persistence of vaccine efficacy for at least 5 years. A Long-Term Persistence Substudy (LTPS) was undertaken to further assess vaccine efficacy in SPS vaccine recipients followed for up to 11 years postvaccination. Study outcomes were assessed for the entire LTPS period and for each year from 7 to 11 years postvaccination. Methods. Surveillance, case determination, and follow-up were comparable to those in SPS and STPS. Because SPS placebo recipients were offered zoster vaccine before the LTPS began, there were no unvaccinated controls. Instead, SPS and STPS placebo results were used to model reference placebo groups. Results. The LTPS enrolled 6867 SPS vaccine recipients. Compared to SPS, estimated vaccine efficacy in LTPS decreased from 61.1% to 37.3% for the herpes zoster (HZ) burden of illness (BOI), from 66.5% to 35.4% for incidence of postherpetic neuralgia, and from 51.3% to 21.1% for incidence of HZ, and declined for all 3 outcome measures from 7 through 11 years postvaccination. Vaccine efficacy for the HZ BOI was significantly greater than zero through year 10 postvaccination, whereas vaccine efficacy for incidence of HZ was significantly greater than zero only through year 8. Conclusions. Estimates of vaccine efficacy decreased over time in the LTPS population compared with modeled control estimates. Statistically significant vaccine efficacy for HZ BOI persisted into year 10 postvaccination, whereas statistically significant vaccine efficacy for incidence of HZ persisted only through year 8.

Original language	English
Pages (from-to)	900-909
Number of pages	10
Journal	Clinical Infectious Diseases
Volume	60
Issue number	6
DOIs	https://doi.org/10.1093/cid/ciu918
State	Published - Mar 15 2015

Bibliographical note

Funding Information:
Financial support. The study was conducted by the Cooperative Studies Program, Department of Veterans Affairs, Office of Research and Development through an agreement between Merck & Co, Inc, and the VA Connecticut Research and Education Foundation (VACREF) under which funding was provided to VACREF by Merck & Co. Additional support was provided by the James R. and Jesse V. Scott Fund for Shingles Research, and by the Intramural Research Program of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

Keywords

Herpes zoster
Herpes zoster burden of illness
Herpes zoster vaccine
Persistence of vaccine efficacy
Postherpetic neuralgia

ASJC Scopus subject areas

Microbiology (medical)
Infectious Diseases

UN SDGs

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

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10.1093/cid/ciu918

Cite this

Morrison, V. A., Johnson, G. R., Schmader, K. E., Levin, M. J., Zhang, J. H., Looney, D. J., Betts, R., Gelb, L., Guatelli, J. C., Harbecke, R., Pachucki, C., Keay, S., Menzies, B., Griffin, M. R., Kauffman, C. A., Marques, A., Toney, J., Boardman, K., Su, S. C., ... Toney, J. F. (2015). Long-term persistence of zoster vaccine efficacy. Clinical Infectious Diseases, 60(6), 900-909. https://doi.org/10.1093/cid/ciu918

@article{da02bfdf81c3493c9b7be2a7a3741cf0,

title = "Long-term persistence of zoster vaccine efficacy",

abstract = "Background. The Shingles Prevention Study (SPS) demonstrated zoster vaccine efficacy through 4 years postvaccination. A Short-Term Persistence Substudy (STPS) demonstrated persistence of vaccine efficacy for at least 5 years. A Long-Term Persistence Substudy (LTPS) was undertaken to further assess vaccine efficacy in SPS vaccine recipients followed for up to 11 years postvaccination. Study outcomes were assessed for the entire LTPS period and for each year from 7 to 11 years postvaccination. Methods. Surveillance, case determination, and follow-up were comparable to those in SPS and STPS. Because SPS placebo recipients were offered zoster vaccine before the LTPS began, there were no unvaccinated controls. Instead, SPS and STPS placebo results were used to model reference placebo groups. Results. The LTPS enrolled 6867 SPS vaccine recipients. Compared to SPS, estimated vaccine efficacy in LTPS decreased from 61.1% to 37.3% for the herpes zoster (HZ) burden of illness (BOI), from 66.5% to 35.4% for incidence of postherpetic neuralgia, and from 51.3% to 21.1% for incidence of HZ, and declined for all 3 outcome measures from 7 through 11 years postvaccination. Vaccine efficacy for the HZ BOI was significantly greater than zero through year 10 postvaccination, whereas vaccine efficacy for incidence of HZ was significantly greater than zero only through year 8. Conclusions. Estimates of vaccine efficacy decreased over time in the LTPS population compared with modeled control estimates. Statistically significant vaccine efficacy for HZ BOI persisted into year 10 postvaccination, whereas statistically significant vaccine efficacy for incidence of HZ persisted only through year 8.",

keywords = "Herpes zoster, Herpes zoster burden of illness, Herpes zoster vaccine, Persistence of vaccine efficacy, Postherpetic neuralgia",

author = "Morrison, {Vicki A.} and Johnson, {Gary R.} and Schmader, {Kenneth E.} and Levin, {Myron J.} and Zhang, {Jane H.} and Looney, {David J.} and Robert Betts and Larry Gelb and Guatelli, {John C.} and Ruth Harbecke and Connie Pachucki and Susan Keay and Barbara Menzies and Griffin, {Marie R.} and Kauffman, {Carol A.} and Adriana Marques and John Toney and Kathy Boardman and Su, {Shu Chih} and Xiaoming Li and Chan, {Ivan S.F.} and Janie Parrino and Paula Annunziato and Oxman, {Michael N.} and Davis, {L. E.} and Kauffman, {C. A.} and Keay, {S. K.} and Straus, {S. E.} and Soto, {N. E.} and P. Brunell and Gnann, {J. W.} and R. Serrao and Cotton, {D. J.} and Goodman, {R. P.} and Arbeit, {R. D.} and Pachucki, {C. T.} and Levin, {M. J.} and Schmader, {K. E.} and Keitel, {W. A.} and Greenberg, {R. N.} and Morrison, {V. A.} and Wright, {P. F.} and Griffin, {M. R.} and Simberkoff, {M. S.} and Yeh, {S. S.} and Z. Lobo and M. Holodniy and J. Loutit and Betts, {R. F.} and Gelb, {L. D.} and Crawford, {G. E.} and J. Guatelli and Brooks, {P. A.} and Looney, {D. J.} and Neuzil, {K. M.} and Toney, {J. F.} and Kauffman, {C. A.} and Keay, {S. K.} and Pachucki, {C. T.} and Levin, {M. J.} and Schmader, {K. E.} and Morrison, {V. A.} and Wright, {P. F.} and Griffin, {M. R.} and Betts, {R. F.} and Gelb, {L. D.} and J. Guatelli and Looney, {D. J.} and Neuzil, {K. M.} and B. Menzies and Toney, {J. F.}",

note = "Funding Information: Financial support. The study was conducted by the Cooperative Studies Program, Department of Veterans Affairs, Office of Research and Development through an agreement between Merck & Co, Inc, and the VA Connecticut Research and Education Foundation (VACREF) under which funding was provided to VACREF by Merck & Co. Additional support was provided by the James R. and Jesse V. Scott Fund for Shingles Research, and by the Intramural Research Program of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.",

year = "2015",

month = mar,

day = "15",

doi = "10.1093/cid/ciu918",

language = "English",

volume = "60",

pages = "900--909",

number = "6",

}

Morrison, VA, Johnson, GR, Schmader, KE, Levin, MJ, Zhang, JH, Looney, DJ, Betts, R, Gelb, L, Guatelli, JC, Harbecke, R, Pachucki, C, Keay, S, Menzies, B, Griffin, MR, Kauffman, CA, Marques, A, Toney, J, Boardman, K, Su, SC, Li, X, Chan, ISF, Parrino, J, Annunziato, P, Oxman, MN, Davis, LE, Kauffman, CA, Keay, SK, Straus, SE, Soto, NE, Brunell, P, Gnann, JW, Serrao, R, Cotton, DJ, Goodman, RP, Arbeit, RD, Pachucki, CT, Levin, MJ, Schmader, KE, Keitel, WA, Greenberg, RN, Morrison, VA, Wright, PF, Griffin, MR, Simberkoff, MS, Yeh, SS, Lobo, Z, Holodniy, M, Loutit, J, Betts, RF, Gelb, LD, Crawford, GE, Guatelli, J, Brooks, PA, Looney, DJ, Neuzil, KM, Toney, JF, Kauffman, CA, Keay, SK, Pachucki, CT, Levin, MJ, Schmader, KE, Morrison, VA, Wright, PF, Griffin, MR, Betts, RF, Gelb, LD, Guatelli, J, Looney, DJ, Neuzil, KM, Menzies, B & Toney, JF 2015, 'Long-term persistence of zoster vaccine efficacy', Clinical Infectious Diseases, vol. 60, no. 6, pp. 900-909. https://doi.org/10.1093/cid/ciu918

TY - JOUR

T1 - Long-term persistence of zoster vaccine efficacy

AU - Morrison, Vicki A.

AU - Johnson, Gary R.

AU - Schmader, Kenneth E.

AU - Levin, Myron J.

AU - Zhang, Jane H.

AU - Looney, David J.

AU - Betts, Robert

AU - Gelb, Larry

AU - Guatelli, John C.

AU - Harbecke, Ruth

AU - Pachucki, Connie

AU - Keay, Susan

AU - Menzies, Barbara

AU - Griffin, Marie R.

AU - Kauffman, Carol A.

AU - Marques, Adriana

AU - Toney, John

AU - Boardman, Kathy

AU - Su, Shu Chih

AU - Li, Xiaoming

AU - Chan, Ivan S.F.

AU - Parrino, Janie

AU - Annunziato, Paula

AU - Oxman, Michael N.

AU - Davis, L. E.

AU - Kauffman, C. A.

AU - Keay, S. K.

AU - Straus, S. E.

AU - Soto, N. E.

AU - Brunell, P.

AU - Gnann, J. W.

AU - Serrao, R.

AU - Cotton, D. J.

AU - Goodman, R. P.

AU - Arbeit, R. D.

AU - Pachucki, C. T.

AU - Levin, M. J.

AU - Schmader, K. E.

AU - Keitel, W. A.

AU - Greenberg, R. N.

AU - Morrison, V. A.

AU - Wright, P. F.

AU - Griffin, M. R.

AU - Simberkoff, M. S.

AU - Yeh, S. S.

AU - Lobo, Z.

AU - Holodniy, M.

AU - Loutit, J.

AU - Betts, R. F.

AU - Gelb, L. D.

AU - Crawford, G. E.

AU - Guatelli, J.

AU - Brooks, P. A.

AU - Looney, D. J.

AU - Neuzil, K. M.

AU - Toney, J. F.

AU - Kauffman, C. A.

AU - Keay, S. K.

AU - Pachucki, C. T.

AU - Levin, M. J.

AU - Schmader, K. E.

AU - Morrison, V. A.

AU - Wright, P. F.

AU - Griffin, M. R.

AU - Betts, R. F.

AU - Gelb, L. D.

AU - Guatelli, J.

AU - Looney, D. J.

AU - Neuzil, K. M.

AU - Menzies, B.

AU - Toney, J. F.

N1 - Funding Information: Financial support. The study was conducted by the Cooperative Studies Program, Department of Veterans Affairs, Office of Research and Development through an agreement between Merck & Co, Inc, and the VA Connecticut Research and Education Foundation (VACREF) under which funding was provided to VACREF by Merck & Co. Additional support was provided by the James R. and Jesse V. Scott Fund for Shingles Research, and by the Intramural Research Program of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.

PY - 2015/3/15

Y1 - 2015/3/15

N2 - Background. The Shingles Prevention Study (SPS) demonstrated zoster vaccine efficacy through 4 years postvaccination. A Short-Term Persistence Substudy (STPS) demonstrated persistence of vaccine efficacy for at least 5 years. A Long-Term Persistence Substudy (LTPS) was undertaken to further assess vaccine efficacy in SPS vaccine recipients followed for up to 11 years postvaccination. Study outcomes were assessed for the entire LTPS period and for each year from 7 to 11 years postvaccination. Methods. Surveillance, case determination, and follow-up were comparable to those in SPS and STPS. Because SPS placebo recipients were offered zoster vaccine before the LTPS began, there were no unvaccinated controls. Instead, SPS and STPS placebo results were used to model reference placebo groups. Results. The LTPS enrolled 6867 SPS vaccine recipients. Compared to SPS, estimated vaccine efficacy in LTPS decreased from 61.1% to 37.3% for the herpes zoster (HZ) burden of illness (BOI), from 66.5% to 35.4% for incidence of postherpetic neuralgia, and from 51.3% to 21.1% for incidence of HZ, and declined for all 3 outcome measures from 7 through 11 years postvaccination. Vaccine efficacy for the HZ BOI was significantly greater than zero through year 10 postvaccination, whereas vaccine efficacy for incidence of HZ was significantly greater than zero only through year 8. Conclusions. Estimates of vaccine efficacy decreased over time in the LTPS population compared with modeled control estimates. Statistically significant vaccine efficacy for HZ BOI persisted into year 10 postvaccination, whereas statistically significant vaccine efficacy for incidence of HZ persisted only through year 8.

AB - Background. The Shingles Prevention Study (SPS) demonstrated zoster vaccine efficacy through 4 years postvaccination. A Short-Term Persistence Substudy (STPS) demonstrated persistence of vaccine efficacy for at least 5 years. A Long-Term Persistence Substudy (LTPS) was undertaken to further assess vaccine efficacy in SPS vaccine recipients followed for up to 11 years postvaccination. Study outcomes were assessed for the entire LTPS period and for each year from 7 to 11 years postvaccination. Methods. Surveillance, case determination, and follow-up were comparable to those in SPS and STPS. Because SPS placebo recipients were offered zoster vaccine before the LTPS began, there were no unvaccinated controls. Instead, SPS and STPS placebo results were used to model reference placebo groups. Results. The LTPS enrolled 6867 SPS vaccine recipients. Compared to SPS, estimated vaccine efficacy in LTPS decreased from 61.1% to 37.3% for the herpes zoster (HZ) burden of illness (BOI), from 66.5% to 35.4% for incidence of postherpetic neuralgia, and from 51.3% to 21.1% for incidence of HZ, and declined for all 3 outcome measures from 7 through 11 years postvaccination. Vaccine efficacy for the HZ BOI was significantly greater than zero through year 10 postvaccination, whereas vaccine efficacy for incidence of HZ was significantly greater than zero only through year 8. Conclusions. Estimates of vaccine efficacy decreased over time in the LTPS population compared with modeled control estimates. Statistically significant vaccine efficacy for HZ BOI persisted into year 10 postvaccination, whereas statistically significant vaccine efficacy for incidence of HZ persisted only through year 8.

KW - Herpes zoster

KW - Herpes zoster burden of illness

KW - Herpes zoster vaccine

KW - Persistence of vaccine efficacy

KW - Postherpetic neuralgia

UR - http://www.scopus.com/inward/record.url?scp=84929884631&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84929884631&partnerID=8YFLogxK

U2 - 10.1093/cid/ciu918

DO - 10.1093/cid/ciu918

M3 - Article

C2 - 25416754

AN - SCOPUS:84929884631

SN - 1058-4838

VL - 60

SP - 900

EP - 909

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

IS - 6

ER -

Long-term persistence of zoster vaccine efficacy

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

UN SDGs

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