Evidence map›Paper›PMID 25712967›Full record

Trial reportThe Journal of infectious diseases2015

Safety and Immunogenicity of a Single Low Dose or High Dose of Clade 2 Influenza A(H5N1) Inactivated Vaccine in Adults Previously Primed With Clade 1 Influenza A(H5N1) Vaccine.

Patricia L Winokur, Shital M Patel, Rebecca Brady, Wilbur H Chen, Samer S El-Kamary, Kathryn Edwards, C Buddy Creech, Sharon Frey, Wendy A Keitel, Robert Belshe and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in The Journal of infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00680069 (A Randomized, Double-Blinded, Phase I/II Study of the Safety, Reactogenicity, and Immunogenicity of an Inactivated Influenza Vaccine Derived From A/H5N1/Indonesia/05/05), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
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.

NCT00680069 phase1 / phase2completednot on this map

A Randomized, Double-Blinded, Phase I/II Study of the Safety, Reactogenicity, and Immunogenicity of an Inactivated Influenza Vaccine Derived From A/H5N1/Indonesia/05/05 (Clade 2) in Healthy Adults and Elderly Who Participated in a Previous A/H5N1/Vietnam/1203/2004 (Clade 1) Vaccine Study

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2008 to 2009Enrolled517ConditionsInfluenzaArmsInfluenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
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.

Patricia L WinokurDepartment of Internal Medicine, University of Iowa and Iowa City VA Healthcare System.
Shital M PatelDepartment of Medicine Department of Molecular Virology, and Microbiology, Baylor College of Medicine, Houston, Texas.
Rebecca BradyGamble Program for Clinical Studies, Cincinnati Children's Hospital, Ohio.
Wilbur H ChenCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore.
Samer S El-KamaryCenter for Vaccine Development, University of Maryland School of Medicine, Baltimore.
Kathryn EdwardsDepartment of Pediatrics, Vanderbilt University, Nashville, Tennessee.
C Buddy CreechDepartment of Pediatrics, Vanderbilt University, Nashville, Tennessee.
Sharon FreyDepartment of Internal Medicine, Saint Louis University, Missouri.
Wendy A KeitelDepartment of Molecular Virology, and Microbiology, Baylor College of Medicine, Houston, Texas.
Robert BelsheDepartment of Internal Medicine, Saint Louis University, Missouri.
Emmanuel WalterDepartment of Pediatrics, Duke University School of Medicine, Durham, North Carolina.
Abbie BellamyEMMES Corporation, Rockville, Maryland.
Heather HillEMMES Corporation, Rockville, Maryland.

Funding

The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
Zonulin Antibodies in Intestinal Permeabilitiy in IDDMM01RR016500 · NCRR · UNIVERSITY OF MARYLAND BALTIMORE · PI OSWALD, LYNN M · 2002 to 2009
$20.2M
Clinical Research Career Development (RMI)K12RR023250 · NCRR · UNIVERSITY OF MARYLAND BALTIMORE · PI SHULDINER, ALAN R. · 2005 to 2009
$13.3M
University of Iowa Clinical and Translational Science ProgramUL1TR000442 · NCATS · UNIVERSITY OF IOWA · PI ROSENTHAL, GARY E · 2012 to 2013
$10.0M
NCATS NIH HHS UL1 TR000442NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1TR000445NCRR NIH HHS K12 RR023250NCRR NIH HHS K12-RR-023250NCRR NIH HHS M01 RR016500NCRR NIH HHS M01RR 16500NIAID NIH HHS HHSN272200800001CNIAID NIH HHS HHSN272200800001GNIAID NIH HHS HHSN272200800001INIAID NIH HHS HHSN272200800001ONIAID NIH HHS HHSN272200800002CNIAID NIH HHS HHSN272200800003CNIAID NIH HHS HHSN272200800006CNIAID NIH HHS HHSN272200800007CNIAID NIH HHS HHSN272200800008CPHS HHS HHSN272200800001CPHS HHS HHSN272200800002PHS HHS HHSN272200800003CPHS HHS HHSN272200800007CPHS HHS HHSN272200800008C
6 · The paper itself

Abstract

Influenza A(H5N1) vaccination strategies that improve the speed of the immunological response and cross-clade protection are desired. We compared the immunogenicity of a single 15-μg or 90-μg dose of A/H5N1/Indonesia/05/05 (clade 2) vaccine in adults who were previously primed with A/H5N1/Vietnam/1203/2004 (clade 1) vaccine. High-dose vaccine resulted in significantly higher titers to both clade 1 and 2 antigens. Clade 2 titers were unaffected by the previous dose of clade 1 vaccine. Low-dose priming with a mismatched pandemic influenza A(H5N1) vaccine would improve the rapidity, magnitude, and cross-reactivity of the immunological response following a single high-dose, unadjuvanted, pandemic vaccine.

Indexed as

AdultAgedAntibodies, ViralCross ReactionsDose-Response Relationship, ImmunologicDouble-Blind MethodFemaleHumansImmunization, SecondaryInfluenza A Virus, H5N1 SubtypeInfluenza, HumanInfluenza VaccinesMaleMiddle AgedNeutralization TestsVaccines, InactivatedAntibodies, ViralInfluenza VaccinesVaccines, InactivatedH5N1influenzaprime-boostvaccine

Identifiers

PMID25712967
PMCPMC4598805

What OpenQuestion holds

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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.