Safety of zoster vaccine in elderly adults following documented herpes zoster

Vicki A Morrison; Michael N. Oxman; Myron J. Levin; Kenneth E. Schmader; John C. Guatelli; Robert F. Betts; Larry D. Gelb; Constance T. Pachucki; Susan K. Keay; Barbara Menzies; Marie R. Griffin; Carol A. Kauffman; Adriana R. Marques; John F. Toney; Michael S. Simberkoff; Richard Serrao; Robert D. Arbeit; John W. Gnann; Richard N. Greenberg; Mark Holodniy; Wendy A. Keitel; Shingshing S. Yeh; Larry E. Davis; George E. Crawford; Kathy M. Neuzil; Gary R. Johnson; Jane H. Zhang; Rith Harbecke; Ivan S.F. Chan; Paul M. Keller; Heather M. Williams; Kathy D. Boardman; Jeffrey L. Silber; Paula W. Annunziato

doi:10.1093/infdis/jit182

Safety of zoster vaccine in elderly adults following documented herpes zoster

Vicki A Morrison, Michael N. Oxman, Myron J. Levin, Kenneth E. Schmader, John C. Guatelli, Robert F. Betts, Larry D. Gelb, Constance T. Pachucki, Susan K. Keay, Barbara Menzies, Marie R. Griffin, Carol A. Kauffman, Adriana R. Marques, John F. Toney, Michael S. Simberkoff, Richard Serrao, Robert D. Arbeit, John W. Gnann, Richard N. Greenberg, Mark HolodniyWendy A. Keitel, Shingshing S. Yeh, Larry E. Davis, George E. Crawford, Kathy M. Neuzil, Gary R. Johnson, Jane H. Zhang, Rith Harbecke, Ivan S.F. Chan, Paul M. Keller, Heather M. Williams, Kathy D. Boardman, Jeffrey L. Silber, Paula W. Annunziato

Medicine - Veteran's Administration Medical Center

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

37 Scopus citations

Abstract

Background. After completion of the Shingles Prevention Study (SPS; Department of Veterans Affairs Cooperative Studies Program Number 403), SPS participants who had initially received placebo 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. A total of 13 681 SPS placebo recipients who elected to receive zoster vaccine were followed for serious adverse events (SAE) for 28 days after 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 the receipt of zoster vaccine in the 420 recipients with prior HZ was 3.61 years (median interval, 3.77 years [range, 3-85 months]); the interval was <5 years for approximately 80% of recipients. The proportion of vaccinated SPS placebo recipients with prior HZ who developed ≥1 SAE (0.95%) was not significantly different from that of vaccinated SPS placebo recipients with no prior history of HZ (0.66%), and the distribution of SAEs in the 2 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.

Original language	English (US)
Pages (from-to)	559-563
Number of pages	5
Journal	Journal of Infectious Diseases
Volume	208
Issue number	4
DOIs	https://doi.org/10.1093/infdis/jit182
State	Published - Aug 15 2013

Bibliographical note

Funding Information:
Acknowledgments. The study was conducted by the Cooperative Studies Program, Department of Veterans Affairs, Office of Research and Development. Additional support was provided by Merck Sharp & Dohme, 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. Data management and analysis support was provided at West Haven CSPCC by Karen Dellert and Kathy Newvine.

Funding Information:
1Veterans Affairs Medical Center, Minneapolis, and University of Minnesota, Minneapolis, Minnesota, 2Veterans Affairs San Diego Healthcare System and University of California, San Diego; 3University of Colorado-Denver and Health Sciences Center; 4GRECC, Durham Veterans Affairs Medical Center and Duke University Medical Center, Durham, North Carolina; 5University of Rochester, New York, 6Veterans Affairs Medical Center, St. Louis, Missouri; 7Hines Veterans Affairs Medical Center, Hines, llinois; 8Veterans Affairs Maryland Health Care System and University of Maryland School of Medicine, Baltimore; 9Veterans Affairs Medical Center Puget Sound, Seattle, Washington; 10Vanderbilt University Medical Center, Nashville, Tennessee;11Veterans Affairs Ann Arbor Healthcare System and University of Michigan Medical School, Ann Arbor; 12National Institutes of Allergy and Infectious Diseases, Bethesda, Maryland; 13Veterans Affairs Medical Center, Tampa, Florida; 14VA New York Harbor Healthcare System and New York University School of Medicine, New York City; 15Veterans Affairs Medical Center and Boston University, Massachusetts; 16Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham; 17Lexington VA Medical Center and University of Kentucky School of Medicine, Kentucky; 18Veterans Affairs Palo Alto Health Care System, California; 19Baylor College of Medicine, Houston, Texas; 20Northport Veterans Affairs Medical Center, Northport, New York; 21Veterans Affairs Medical Center, Albuquerque, New Mexico; 22University of Texas Health Sciences Center, San Antonio, Texas; 23Department of Veterans Affairs Cooperative Studies Program Coordinating Center, West Haven, Conneticut; 24Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey; and 25Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico

Keywords

ACIP recommendations
Herpes zoster
Zoster vaccine
Zoster vaccine in elderly persons
Zoster vaccine safety

UN SDGs

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

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10.1093/infdis/jit182

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Morrison, V. A., Oxman, M. N., Levin, M. J., Schmader, K. E., Guatelli, J. C., Betts, R. F., Gelb, L. D., Pachucki, C. T., Keay, S. K., Menzies, B., Griffin, M. R., Kauffman, C. A., Marques, A. R., Toney, J. F., Simberkoff, M. S., Serrao, R., Arbeit, R. D., Gnann, J. W., Greenberg, R. N., ... Annunziato, P. W. (2013). Safety of zoster vaccine in elderly adults following documented herpes zoster. Journal of Infectious Diseases, 208(4), 559-563. https://doi.org/10.1093/infdis/jit182

Morrison, VA, Oxman, MN, Levin, MJ, Schmader, KE, Guatelli, JC, Betts, RF, Gelb, LD, Pachucki, CT, Keay, SK, Menzies, B, Griffin, MR, Kauffman, CA, Marques, AR, Toney, JF, Simberkoff, MS, Serrao, R, Arbeit, RD, Gnann, JW, Greenberg, RN, Holodniy, M, Keitel, WA, Yeh, SS, Davis, LE, Crawford, GE, Neuzil, KM, Johnson, GR, Zhang, JH, Harbecke, R, Chan, ISF, Keller, PM, Williams, HM, Boardman, KD, Silber, JL & Annunziato, PW 2013, 'Safety of zoster vaccine in elderly adults following documented herpes zoster', Journal of Infectious Diseases, vol. 208, no. 4, pp. 559-563. https://doi.org/10.1093/infdis/jit182

@article{efc12734857c47059d9fca36796bded1,

title = "Safety of zoster vaccine in elderly adults following documented herpes zoster",

abstract = "Background. After completion of the Shingles Prevention Study (SPS; Department of Veterans Affairs Cooperative Studies Program Number 403), SPS participants who had initially received placebo 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. A total of 13 681 SPS placebo recipients who elected to receive zoster vaccine were followed for serious adverse events (SAE) for 28 days after 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 the receipt of zoster vaccine in the 420 recipients with prior HZ was 3.61 years (median interval, 3.77 years [range, 3-85 months]); the interval was <5 years for approximately 80% of recipients. The proportion of vaccinated SPS placebo recipients with prior HZ who developed ≥1 SAE (0.95%) was not significantly different from that of vaccinated SPS placebo recipients with no prior history of HZ (0.66%), and the distribution of SAEs in the 2 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.",

keywords = "ACIP recommendations, Herpes zoster, Zoster vaccine, Zoster vaccine in elderly persons, Zoster vaccine safety",

author = "Morrison, {Vicki A} and Oxman, {Michael N.} and Levin, {Myron J.} and Schmader, {Kenneth E.} and Guatelli, {John C.} and Betts, {Robert F.} and Gelb, {Larry D.} and Pachucki, {Constance T.} and Keay, {Susan K.} and Barbara Menzies and Griffin, {Marie R.} and Kauffman, {Carol A.} and Marques, {Adriana R.} and Toney, {John F.} and Simberkoff, {Michael S.} and Richard Serrao and Arbeit, {Robert D.} and Gnann, {John W.} and Greenberg, {Richard N.} and Mark Holodniy and Keitel, {Wendy A.} and Yeh, {Shingshing S.} and Davis, {Larry E.} and Crawford, {George E.} and Neuzil, {Kathy M.} and Johnson, {Gary R.} and Zhang, {Jane H.} and Rith Harbecke and Chan, {Ivan S.F.} and Keller, {Paul M.} and Williams, {Heather M.} and Boardman, {Kathy D.} and Silber, {Jeffrey L.} and Annunziato, {Paula W.}",

note = "Funding Information: Acknowledgments. The study was conducted by the Cooperative Studies Program, Department of Veterans Affairs, Office of Research and Development. Additional support was provided by Merck Sharp & Dohme, 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. Data management and analysis support was provided at West Haven CSPCC by Karen Dellert and Kathy Newvine. Funding Information: 1Veterans Affairs Medical Center, Minneapolis, and University of Minnesota, Minneapolis, Minnesota, 2Veterans Affairs San Diego Healthcare System and University of California, San Diego; 3University of Colorado-Denver and Health Sciences Center; 4GRECC, Durham Veterans Affairs Medical Center and Duke University Medical Center, Durham, North Carolina; 5University of Rochester, New York, 6Veterans Affairs Medical Center, St. Louis, Missouri; 7Hines Veterans Affairs Medical Center, Hines, llinois; 8Veterans Affairs Maryland Health Care System and University of Maryland School of Medicine, Baltimore; 9Veterans Affairs Medical Center Puget Sound, Seattle, Washington; 10Vanderbilt University Medical Center, Nashville, Tennessee;11Veterans Affairs Ann Arbor Healthcare System and University of Michigan Medical School, Ann Arbor; 12National Institutes of Allergy and Infectious Diseases, Bethesda, Maryland; 13Veterans Affairs Medical Center, Tampa, Florida; 14VA New York Harbor Healthcare System and New York University School of Medicine, New York City; 15Veterans Affairs Medical Center and Boston University, Massachusetts; 16Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham; 17Lexington VA Medical Center and University of Kentucky School of Medicine, Kentucky; 18Veterans Affairs Palo Alto Health Care System, California; 19Baylor College of Medicine, Houston, Texas; 20Northport Veterans Affairs Medical Center, Northport, New York; 21Veterans Affairs Medical Center, Albuquerque, New Mexico; 22University of Texas Health Sciences Center, San Antonio, Texas; 23Department of Veterans Affairs Cooperative Studies Program Coordinating Center, West Haven, Conneticut; 24Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey; and 25Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico",

year = "2013",

month = aug,

day = "15",

doi = "10.1093/infdis/jit182",

language = "English (US)",

volume = "208",

pages = "559--563",

journal = "Journal of Infectious Diseases",

issn = "0022-1899",

publisher = "Oxford University Press",

number = "4",

}

TY - JOUR

T1 - Safety of zoster vaccine in elderly adults following documented herpes zoster

AU - Morrison, Vicki A

AU - Oxman, Michael N.

AU - Levin, Myron J.

AU - Schmader, Kenneth E.

AU - Guatelli, John C.

AU - Betts, Robert F.

AU - Gelb, Larry D.

AU - Pachucki, Constance T.

AU - Keay, Susan K.

AU - Menzies, Barbara

AU - Griffin, Marie R.

AU - Kauffman, Carol A.

AU - Marques, Adriana R.

AU - Toney, John F.

AU - Simberkoff, Michael S.

AU - Serrao, Richard

AU - Arbeit, Robert D.

AU - Gnann, John W.

AU - Greenberg, Richard N.

AU - Holodniy, Mark

AU - Keitel, Wendy A.

AU - Yeh, Shingshing S.

AU - Davis, Larry E.

AU - Crawford, George E.

AU - Neuzil, Kathy M.

AU - Johnson, Gary R.

AU - Zhang, Jane H.

AU - Harbecke, Rith

AU - Chan, Ivan S.F.

AU - Keller, Paul M.

AU - Williams, Heather M.

AU - Boardman, Kathy D.

AU - Silber, Jeffrey L.

AU - Annunziato, Paula W.

N1 - Funding Information: Acknowledgments. The study was conducted by the Cooperative Studies Program, Department of Veterans Affairs, Office of Research and Development. Additional support was provided by Merck Sharp & Dohme, 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. Data management and analysis support was provided at West Haven CSPCC by Karen Dellert and Kathy Newvine. Funding Information: 1Veterans Affairs Medical Center, Minneapolis, and University of Minnesota, Minneapolis, Minnesota, 2Veterans Affairs San Diego Healthcare System and University of California, San Diego; 3University of Colorado-Denver and Health Sciences Center; 4GRECC, Durham Veterans Affairs Medical Center and Duke University Medical Center, Durham, North Carolina; 5University of Rochester, New York, 6Veterans Affairs Medical Center, St. Louis, Missouri; 7Hines Veterans Affairs Medical Center, Hines, llinois; 8Veterans Affairs Maryland Health Care System and University of Maryland School of Medicine, Baltimore; 9Veterans Affairs Medical Center Puget Sound, Seattle, Washington; 10Vanderbilt University Medical Center, Nashville, Tennessee;11Veterans Affairs Ann Arbor Healthcare System and University of Michigan Medical School, Ann Arbor; 12National Institutes of Allergy and Infectious Diseases, Bethesda, Maryland; 13Veterans Affairs Medical Center, Tampa, Florida; 14VA New York Harbor Healthcare System and New York University School of Medicine, New York City; 15Veterans Affairs Medical Center and Boston University, Massachusetts; 16Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham; 17Lexington VA Medical Center and University of Kentucky School of Medicine, Kentucky; 18Veterans Affairs Palo Alto Health Care System, California; 19Baylor College of Medicine, Houston, Texas; 20Northport Veterans Affairs Medical Center, Northport, New York; 21Veterans Affairs Medical Center, Albuquerque, New Mexico; 22University of Texas Health Sciences Center, San Antonio, Texas; 23Department of Veterans Affairs Cooperative Studies Program Coordinating Center, West Haven, Conneticut; 24Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey; and 25Department of Veterans Affairs Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, New Mexico

PY - 2013/8/15

Y1 - 2013/8/15

N2 - Background. After completion of the Shingles Prevention Study (SPS; Department of Veterans Affairs Cooperative Studies Program Number 403), SPS participants who had initially received placebo 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. A total of 13 681 SPS placebo recipients who elected to receive zoster vaccine were followed for serious adverse events (SAE) for 28 days after 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 the receipt of zoster vaccine in the 420 recipients with prior HZ was 3.61 years (median interval, 3.77 years [range, 3-85 months]); the interval was <5 years for approximately 80% of recipients. The proportion of vaccinated SPS placebo recipients with prior HZ who developed ≥1 SAE (0.95%) was not significantly different from that of vaccinated SPS placebo recipients with no prior history of HZ (0.66%), and the distribution of SAEs in the 2 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.

AB - Background. After completion of the Shingles Prevention Study (SPS; Department of Veterans Affairs Cooperative Studies Program Number 403), SPS participants who had initially received placebo 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. A total of 13 681 SPS placebo recipients who elected to receive zoster vaccine were followed for serious adverse events (SAE) for 28 days after 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 the receipt of zoster vaccine in the 420 recipients with prior HZ was 3.61 years (median interval, 3.77 years [range, 3-85 months]); the interval was <5 years for approximately 80% of recipients. The proportion of vaccinated SPS placebo recipients with prior HZ who developed ≥1 SAE (0.95%) was not significantly different from that of vaccinated SPS placebo recipients with no prior history of HZ (0.66%), and the distribution of SAEs in the 2 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.

KW - ACIP recommendations

KW - Herpes zoster

KW - Zoster vaccine

KW - Zoster vaccine in elderly persons

KW - Zoster vaccine safety

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ER -

Safety of zoster vaccine in elderly adults following documented herpes zoster

Abstract

Bibliographical note

Keywords

UN SDGs

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