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Long-term persistence of zoster vaccine efficacy.

AbstractBACKGROUND:
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.
AuthorsVicki 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, Shingles Prevention Study Group
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 60 Issue 6 Pg. 900-9 (Mar 15 2015) ISSN: 1537-6591 [Electronic] United States
PMID25416754 (Publication Type: Journal Article, Research Support, N.I.H., Intramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, Non-P.H.S.)
CopyrightPublished by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.
Chemical References
  • Herpes Zoster Vaccine
Topics
  • Aged
  • Aged, 80 and over
  • Cost of Illness
  • Epidemiological Monitoring
  • Female
  • Follow-Up Studies
  • Herpes Zoster (complications, epidemiology, prevention & control)
  • Herpes Zoster Vaccine (adverse effects, immunology)
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Neuralgia, Postherpetic (epidemiology, prevention & control)
  • Vaccination
  • Vaccine Potency

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