Evidence map›Paper›PMID 24823623›Full record

Trial reportThe Journal of infectious diseases2014

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.

Peter B Gilbert, Erin E Gabriel, Xiaopeng Miao, Xiaoming Li, Shu-Chih Su, Janie Parrino, Ivan S F Chan

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 55 papers.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed
7.5field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00534248 phase3completednot on this map

A Phase III Clinical Trial to Evaluate the Efficacy, Immunogenicity, Safety and Tolerability of Zostavax™ in Subjects 50-59 Years of Age

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2007 to 2010Enrolled22,439ConditionsShinglesArmsZoster Vaccine, Live (Zostavax™), Comparator: Placebo
NCT03192319 nacompletednot on this mapstarted 2017, after this paper: background citation

Comparison of Change in Humoral and Cellular Immunity Induced by Zoster Vaccine According to the Timing of Vaccination After Hematopoietic Stem Cell Transplantation

TypeinterventionalSponsorSeoul National University HospitalRan2017 to 2018Enrolled86ConditionsHerpes ZosterArmsZostavax
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 100 citations in OpenAlex.

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  6. IgA and IgG1 Specific to Vi Polysaccharide ofFrontiers in immunology · 2019
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  12. Varicella zoster virus and the central nervous system.Nature reviews. Microbiology · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center and Department of Biostatistics, University of Washington.
Erin E GabrielNational Institute of Allergy and Infectious Diseases, Biostatistics Research Branch, Bethesda, Maryland.
Xiaopeng MiaoDepartment of Biometrics, Biogen Idec, Cambridge, Massachusetts.
Xiaoming LiBiostatistics, Gilead Sciences, Seattle, Washington.
Shu-Chih SuMerck, Whitehouse Station, New Jersey.
Janie ParrinoMerck, Whitehouse Station, New Jersey.
Ivan S F ChanMerck, Whitehouse Station, New Jersey.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USBiogen (United States) · USFred Hutch Cancer Center · USGilead Sciences (United States) · USNational Institute of Allergy and Infectious Diseases · US

Funding

SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Statistical Methods in HIV Vaccine Efficacy TrialsR37AI054165 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert · 2010 to 2026
$6.7M
Methods for Evaluating Vaccine EfficacyR37AI032042 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI HALLORAN, M ELIZABETH · 2010 to 2019
$5.1M
NIAID NIH HHS 2 R37 AI054165-11NIAID NIH HHS R37 AI032042NIAID NIH HHS R37-AI032042NIAID NIH HHS R37 AI054165NIAID NIH HHS UM1 AI068635
6 · The paper itself

Abstract

backgroundThe phase III Zostavax Efficacy and Safety Trial of 1 dose of licensed zoster vaccine (ZV; Zostavax; Merck) in 50-59-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.

methodsThe 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.

resultsThe 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.

conclusionsThe analysis illustrates the value of the VE curve framework for assessing immune response biomarkers as CoPs in vaccine efficacy trials. CLINICAL TRIALS REGISTRATION: NCT00534248.

Indexed as

Antibodies, ViralBiomarkersEnzyme-Linked Immunosorbent AssayFemaleHerpesvirus 3, HumanHerpes ZosterHerpes Zoster VaccineHumansMaleMiddle AgedAntibodies, ViralBiomarkersHerpes Zoster Vaccinecausal inferencecorrelate of immunityimmune correlate of protectionprincipal stratificationsignature of protectionstatistical analysissurrogate endpointvaccine efficacy trial

Identifiers

PMID24823623
PMCPMC4215071
OpenAlexW2131427505

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.