{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T06:38:11Z","timestamp":1789886291724,"version":"4.0.1"},"reference-count":41,"publisher":"Oxford University Press (OUP)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2014,11,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Background. \u2003The phase III Zostavax Efficacy and Safety Trial of 1 dose of licensed zoster vaccine (ZV; Zostavax; Merck) in 50\u201359-year-olds showed approximately 70% vaccine efficacy (VE) to reduce the incidence of herpes zoster (HZ). An objective of the trial was to assess immune response biomarkers measuring antibodies to varicella zoster virus (VZV) by glycoprotein-based enzyme-linked immunosorbent assay as correlates of protection (CoPs) against HZ.<\/jats:p>\n                  <jats:p>Methods. \u2003The principal stratification vaccine efficacy curve framework for statistically evaluating immune response biomarkers as CoPs was applied. The VE curve describes how VE against the clinical end point (HZ) varies across participant subgroups defined by biomarker readout measuring vaccine-induced immune response. The VE curve was estimated using several subgroup definitions.<\/jats:p>\n                  <jats:p>Results. \u2003The fold rise in VZV antibody titers from the time before immunization to 6 weeks after immunization was an excellent CoP, with VE increasing sharply with fold rise: VE was estimated at 0% for the subgroup with no rise and at 90% for the subgroup with 5.26-fold rise. In contrast, VZV antibody titers measured 6 weeks after immunization did not predict VE, with similar estimated VEs across titer subgroups.<\/jats:p>\n                  <jats:p>Conclusions. \u2003The analysis illustrates the value of the VE curve framework for assessing immune response biomarkers as CoPs in vaccine efficacy trials.<\/jats:p>\n                  <jats:p>Clinical Trials Registration. \u2003NCT00534248.<\/jats:p>","DOI":"10.1093\/infdis\/jiu279","type":"journal-article","created":{"date-parts":[[2014,5,14]],"date-time":"2014-05-14T01:07:04Z","timestamp":1400029624000},"page":"1573-1581","source":"Crossref","is-referenced-by-count":97,"title":["Fold Rise in Antibody Titers by Measured by Glycoprotein-Based Enzyme-Linked Immunosorbent Assay Is an Excellent Correlate of Protection for a Herpes Zoster Vaccine, Demonstrated via the Vaccine Efficacy Curve"],"prefix":"10.1093","volume":"210","author":[{"given":"Peter B.","family":"Gilbert","sequence":"first","affiliation":[{"name":"University of Washington 1 \u00a0 Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center and Department of Biostatistics ,"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erin E.","family":"Gabriel","sequence":"additional","affiliation":[{"name":"National Institute of Allergy and Infectious Diseases, Biostatistics Research Branch 3 \u00a0 , Bethesda, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaopeng","family":"Miao","sequence":"additional","affiliation":[{"name":"Biogen Idec 4 \u00a0 Department of Biometrics , , Cambridge, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoming","family":"Li","sequence":"additional","affiliation":[{"name":"2 \u00a0Biostatistics, Gilead Sciences, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shu-Chih","family":"Su","sequence":"additional","affiliation":[{"name":"5 \u00a0Merck, Whitehouse Station, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janie","family":"Parrino","sequence":"additional","affiliation":[{"name":"5 \u00a0Merck, Whitehouse Station, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan S. 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