Evidence map›Paper›PMID 25237196›Full record

Trial reportBlood2014

A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients.

Edward A Stadtmauer, Keith M Sullivan, Francisco M Marty, Sanjeet S Dadwal, Genovefa A Papanicolaou, Thomas C Shea, Sherif B Mossad, Charalambos Andreadis, Jo-Anne H Young, Francis K Buadi and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00920218 (Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A), which is not on this map. Cited by 72 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 5 pooled it
10.7field-weighted citation impact, top 1% 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.

NCT00920218 phase2completednot on this map

Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A

TypeinterventionalSponsorGlaxoSmithKlineRan2009 to 2012Enrolled121ConditionsHerpes ZosterArmsHerpes Zoster Vaccine 1437173A, Placebo vaccine (saline)
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 5 syntheses or guidelines pooled it, 177 citations in OpenAlex.

  1. Pooled it
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  5. Herpes Zoster Risk in Immunocompromised Adults in the United States: A Systematic Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020
    Pooled it
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12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 12 institutions in 2 countries.

Edward A StadtmauerUniversity of Pennsylvania, Perelman School of Medicine, Philadelphia, PA;
Keith M SullivanDuke University Medical Center, Durham, NC;
Francisco M MartyDana-Farber Cancer Institute and Brigham & Women's Hospital, Boston, MA;
Sanjeet S DadwalCity of Hope, Duarte, CA;
Genovefa A PapanicolaouMemorial Sloan-Kettering Cancer Center, New York, NY;
Thomas C SheaUniversity of North Carolina Hospital, Chapel Hill, NC;
Sherif B MossadCleveland Clinic Foundation, Cleveland, OH;
Charalambos AndreadisUniversity of California Medical Center, San Francisco, CA;
Jo-Anne H YoungUniversity of Minnesota, Minneapolis, MN;
Francis K BuadiMayo Clinic, Rochester, MN;
Mohamed El IdrissiGlaxoSmithKline Vaccines, Wavre, Belgium; and.
Thomas C HeinemanGlaxoSmithKline Vaccines, King of Prussia, PA.
Elchonon M BerkowitzGlaxoSmithKline Vaccines, King of Prussia, PA.
GlaxoSmithKline (United States) · USBrigham and Women's Hospital · USCity of Hope · USCleveland Clinic · USDuke Medical Center · USGlaxoSmithKline (Belgium) · BEMayo Clinic in Arizona · USMemorial Sloan Kettering Cancer Center · USUniversity of California San Francisco Medical Center · USUniversity of Minnesota · USUniversity of North Carolina Hospitals · USUniversity of Pennsylvania · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Mayo Clinic Center for Translational Science ActivitiesUL1TR000135 · NCATS · MAYO CLINIC ROCHESTER · PI KHOSLA, SUNDEEP · 2012 to 2015
$41.2M
NCATS NIH HHS UL1 TR000135NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

Recombinant herpes zoster (HZ) vaccines may be an alternative to the live-attenuated HZ vaccine for immunocompromised individuals. This was a phase 1/2, randomized, observer-blind, placebo-controlled study in adults with multiple myeloma, non-Hodgkin lymphoma (B- or T-cell), Hodgkin lymphoma, or acute myeloid leukemia who had undergone autologous hematopoietic stem-cell transplant 50 to 70 days earlier. Subjects (N = 121) were randomized 1:1:1:1 to receive (at months 0, 1, 3) three doses of 50 μg varicella-zoster virus glycoprotein E (gE) adjuvanted with AS01B, 3 doses of gE adjuvanted with AS01E, 1 dose of saline followed by 2 doses of gE/AS01B, or 3 doses of saline. One month after the last dose (6 months after transplant), frequencies of CD4(+) T cells expressing ≥2 activation markers after induction with gE and anti-gE antibody concentrations were higher with all gE/AS01 regimens than with saline. Both responses persisted up to 1 year in subjects vaccinated with gE/AS01. Immune responses were higher in the gE/AS01B 3-dose group than in the gE/AS01B 2-dose group but not higher than in the gE/AS01E 3-dose group. One serious adverse event (pneumonia) was considered vaccine related. Both formulations and both schedules were immunogenic and well tolerated in this population. This study was registered at www.clinicaltrials.gov as #NCT00920218.

Indexed as

AdultAgedDouble-Blind MethodFemaleHematologic NeoplasmsHematopoietic Stem Cell TransplantationHerpesvirus 3, HumanHerpes Zoster VaccineHodgkin DiseaseHumansLeukemia, Myeloid, AcuteLymphoma, Non-HodgkinMaleMiddle AgedMultiple MyelomaTransplantation, AutologousHerpes Zoster Vaccine

Identifiers

PMID25237196
PMCPMC4327150
OpenAlexW2089359789

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.