Vicki A Morrison1, Gary R Johnson2, Kenneth E Schmader3, Myron J Levin4, Jane H Zhang2, David J Looney5, Robert Betts6, Larry Gelb7, John C Guatelli5, Ruth Harbecke5, Connie Pachucki8, Susan Keay9, Barbara Menzies10, Marie R Griffin11, Carol A Kauffman12, Adriana Marques13, John Toney14, Kathy Boardman15, Shu-Chih Su16, Xiaoming Li16, Ivan S F Chan16, Janie Parrino16, Paula Annunziato16, Michael N Oxman5. 1. Veterans Affairs Medical Center and University of Minnesota, Minneapolis. 2. Cooperative Studies Program Coordinating Center, Veterans Affairs Connecticut Healthcare System, West Haven. 3. Geriatric Research Education and Clinical Centers (GRECC), Durham Veterans Affairs Medical Center and Duke University, North Carolina. 4. University of Colorado Denver, Anschutz Medical Campus, Aurora. 5. Veterans Affairs San Diego Healthcare System and University of California, San Diego. 6. University of Rochester, New York. 7. Veterans Affairs Medical Center, St Louis, Missouri. 8. Hines Veterans Affairs Medical Center, Chicago, Illinois. 9. Veterans Affairs Maryland Health Care System and University of Maryland, Baltimore. 10. Veterans Affairs Medical Center, Seattle, Washington. 11. Vanderbilt University and Mid-South GRECC, Veterans Affairs Tennessee Valley Healthcare System, Nashville. 12. Veterans Affairs Ann Arbor Health Care System and University Of Michigan, Ann Arbor. 13. National Institute of Allergy and Infectious Diseases, Bethesda, Maryland. 14. Veterans Affairs Medical Center, Tampa, Florida. 15. Cooperative Studies Program Central Research Pharmacy Coordinating Center, Albuquerque, New Mexico. 16. Merck and Co, Whitehouse Station, New Jersey.
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. Published 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.
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. Published 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.
Entities:
Keywords:
herpes zoster; herpes zoster burden of illness; herpes zoster vaccine; persistence of vaccine efficacy; postherpetic neuralgia
Authors: Aisha O Jumaan; Onchee Yu; Lisa A Jackson; Kari Bohlke; Karin Galil; Jane F Seward Journal: J Infect Dis Date: 2005-05-12 Impact factor: 5.226
Authors: Paul M Coplan; Kenneth Schmader; Alexander Nikas; Ivan S F Chan; Peter Choo; Myron J Levin; Gary Johnson; Mark Bauer; Heather M Williams; Karen M Kaplan; Harry A Guess; Michael N Oxman Journal: J Pain Date: 2004-08 Impact factor: 5.820