Evidence map›Paper›PMID 25649171›Full record

ArticleThe Journal of infectious diseases2015

Safety and Immunogenicity of a Subvirion Monovalent Unadjuvanted Inactivated Influenza A(H3N2) Variant Vaccine in Healthy Persons ≥18 Years Old.

Wendy A Keitel, Lisa A Jackson, Srilatha Edupuganti, Patricia L Winokur, Mark J Mulligan, Natalie J Thornburg, Shital M Patel, Nadine G Rouphael, Lilin Lai, Sandhya Bangaru and 4 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article 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 NCT01746082 (A Phase II Open-Label Study in Healthy Adult and Elderly Populations to Assess the Safety, Reactogenicity, and Immunogenicity of an Intramuscular Unadjuvanted Subvirion Monovalent Inactivated Influenza H3N2 Variant), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT01746082 phase2completednot on this map

A Phase II Open-Label Study in Healthy Adult and Elderly Populations to Assess the Safety, Reactogenicity, and Immunogenicity of an Intramuscular Unadjuvanted Subvirion Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2013 to 2013Enrolled211ConditionsInfluenzaArmsInfluenza A/H3N2 variant Vaccine
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Vaccine and Treatment Evaluation Units: A Historical Perspective.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  3. 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
  4. Article
  5. Article
  6. Article
  7. Antibody Determinants of Influenza Immunity.The Journal of infectious diseases · 2019
    Article
  8. Article
  9. 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

14 authors.

Wendy A KeitelDepartment of Molecular Virology & Microbiology Department of Medicine, Baylor College of Medicine, Houston, Texas.
Lisa A JacksonGroup Health Research Institute, Seattle, Washington.
Srilatha EdupugantiThe Hope Clinic of the Emory Vaccine Center Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia.
Patricia L WinokurDepartment of Internal Medicine, University of Iowa Iowa City VA Health System, Iowa City.
Mark J MulliganThe Hope Clinic of the Emory Vaccine Center Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia.
Natalie J ThornburgVanderbilt Vaccine Center Department of Pathology, Microbiology and Immunology Department of Pediatrics, Vanderbilt University, Nashville, Tennessee.
Shital M PatelDepartment of Molecular Virology & Microbiology Department of Medicine, Baylor College of Medicine, Houston, Texas.
Nadine G RouphaelThe Hope Clinic of the Emory Vaccine Center Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia.
Lilin LaiThe Hope Clinic of the Emory Vaccine Center Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia.
Sandhya BangaruVanderbilt Vaccine Center Department of Pathology, Microbiology and Immunology Department of Pediatrics, Vanderbilt University, Nashville, Tennessee.
Monica M McNealCincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio.
Abbie R BellamyEMMES Corporation, Rockville, Maryland.
Heather R HillEMMES Corporation, Rockville, Maryland.
VTEU H3N2v Vaccine Study Work Group

Funding

Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
The University of Iowa Clinical and Translational Science AwardU54TR001356 · NCATS · UNIVERSITY OF IOWA · PI WINOKUR, PATRICIA · 2015 to 2016
$7.1M
Training a New Generation of VaccinologistsT32AI074492 · NIAID · EMORY UNIVERSITY · PI Rama Rao Amara, Benjamin A Lopman · 2009 to 2026
$6.4M
NCATS NIH HHS U54 TR001356NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1TR000454NIAID NIH HHS HHSN272200800002CNIAID NIH HHS HHSN272200800004CNIAID NIH HHS HHSN272200800005CNIAID NIH HHS HHSN272200800006CNIAID NIH HHS HHSN272200800007CNIAID NIH HHS HHSN272200800008CNIAID NIH HHS HHSN272200800013CNIAID NIH HHS T32 AI074492PHS HHS HHSN272200800002CPHS HHS HHSN272200800004CPHS HHS HHSN272200800005CPHS HHS HHSN272200800006CPHS HHS HHSN272200800007CPHS HHS HHSN272200800008CPHS HHS HHSN272200800013C
6 · The paper itself

Abstract

backgroundVariant influenza A(H3N2) viruses (H3N2v) have transmitted recently from pigs to humans in the United States. Vaccines strategies are needed.

methodsHealthy adults received 2 doses of subvirion H3N2v vaccine (15 µg of hemagglutinin/dose) 21 days apart in this open-label trial. Serum hemagglutination inhibition (HAI) and neutralizing (Neut) antibody (Ab) titers were measured before and 8 and 21 days after each dose. Memory B-cell (MBC) responses were assessed.

resultsVaccine was well tolerated. A total of 40% of subjects had an HAI Ab titer of ≥40 before vaccination. Eight-seven percent (95% confidence interval [CI], 79%-93%) and 73% (95% CI, 63%-81%) of subjects 18-64 years old (98 subjects) and ≥65 years old (90 subjects), respectively, had an HAI titer of ≥40 21 days after dose 1 (P = .01); 51% (95% CI, 41%-61%) and 52% (95% CI, 41%-62%) of younger and older subjects, respectively, developed ≥4-fold rises in titer (P = not significant). Neut Ab response patterns were similar. Geometric mean titers were higher in younger subjects. Dose 2 provided no significant enhancement in responses. Cross-reactive MBCs were detected before vaccination and expanded after vaccination. Preexisting H3N2v-specific MBCs positively correlated with early increases in vaccine-induced Ab.

conclusionsIn most healthy adults, one 15-µg dose of vaccine elicited levels of HAI Abs associated with protection. Studies in children and elderly individuals are indicated to define the immunization needs of these groups. CLINICAL TRIALS REGISTRATION: NCT01746082.

Indexed as

AdolescentAdultAgedAntibodies, ViralB-LymphocytesFemaleHumansImmunoglobulin GInfluenza A Virus, H3N2 SubtypeInfluenza, HumanInfluenza VaccinesMaleMiddle AgedYoung AdultAntibodies, ViralImmunoglobulin GInfluenza VaccinesH3N2 variantimmune responsesimmunizationinfluenzapandemic

Identifiers

PMID25649171
PMCPMC4539893

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.