Evidence map›Paper›PMID 22275399›Full record

Trial reportThe Journal of infectious diseases2012

Higher antigen content improves the immune response to 2009 H1N1 influenza vaccine in HIV-infected adults: a randomized clinical trial.

Hana M El Sahly, Charles Davis, Karen Kotloff, Jeffery Meier, Patricia L Winokur, Anna Wald, Christine Johnston, Sarah L George, Rebecca C Brady, Corinne Lehmann and 2 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00992433 (A Phase II Study in HIV-seropositive Adults to Assess the Safety and Immunogenicity of an Unadjuvanted Novartis H1N1 Influenza Vaccine Administered at Two Dose Levels), which is not on this map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
3.9field-weighted citation impact, top 6% 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.

NCT00992433 phase2completednot on this map

A Phase II Study in HIV-seropositive Adults to Assess the Safety and Immunogenicity of an Unadjuvanted Novartis H1N1 Influenza Vaccine Administered at Two Dose Levels

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2010Enrolled192ConditionsInfluenzaArmsInactivated Influenza H1N1 vaccine
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 33 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Safety and immunogenicity of 2009 pH1N1 vaccination in HIV-infected pregnant women.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2013
    Trial
  4. Inclusion of Women, Children, the Elderly, and Individuals With Underlying Medical Conditions: Prioritizing Vulnerable Populations in Clinical Research.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  5. Historical Advances in Clinical Trial Design and Expanding Representation as the New Frontier for Innovation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  6. 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
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Traditional and new influenza vaccines.Clinical microbiology reviews · 2013
    Review
  14. Article
  15. Article
  16. Article
  17. Sometimes, more is better.The Journal of infectious diseases · 2012
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 2 countries.

Hana M El SahlyDepartment of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA. hanae@bcm.edu
Charles Davis
Karen Kotloff
Jeffery Meier
Patricia L Winokur
Anna Wald
Christine Johnston
Sarah L George
Rebecca C Brady
Corinne Lehmann
Abbie Stokes-Riner
Wendy A Keitel
Baylor College of Medicine · USUniversity of Iowa · USUniversity of Maryland, Baltimore · USUniversity of Washington · USCincinnati Children's Hospital Medical Center · USEmmes (United States) · USJohn Cochran VA Medical Center · USOffice of Infectious Diseases · US

Funding

INSTITUTE FOR TRANSLATIONAL HEALTH SCIENCE (UL1): BPCAUL1RR025014 · NCRR · UNIVERSITY OF WASHINGTON · PI DISIS, MARY L. · 2007 to 2011
$51.5M
UNIVERSITY OF IOWA CTSA FOR PEDIATRIC RESEARCHUL1RR024979 · NCRR · UNIVERSITY OF IOWA · PI ROSENTHAL, GARY E · 2007 to 2011
$31.8M
EVALUATION OF CONTROL MEASURES AGAINST DISEASES OTHER THAN AIDS-266025464N01AI025464 · NIAID · SAINT LOUIS UNIVERSITY · PI CHAPLESKI, ELIZABETH · 2003 to 2006
–
NCRR NIH HHS UL1 RR024979NCRR NIH HHS UL1RR024979NCRR NIH HHS UL1 RR025014NCRR NIH HHS UL1RR025014NIAID NIH HHS HHSN272200800001CNIAID NIH HHS HHSN272200800001GNIAID NIH HHS HHSN272200800001INIAID NIH HHS HHSN272200800001ONIAID NIH HHS HHSN272200800004CNIAID NIH HHS N01 AI025464NIAID NIH HHS N01AI0800008NIAID NIH HHS N01-AI25464NIAID NIH HHS N01-AI-800002NIAID NIH HHS N01-AI-800006
6 · The paper itself

Abstract

backgroundThe immunogenicity of a high hemagglutinin (HA) dose or a second dose of influenza vaccine in human immunodeficiency virus (HIV)-infected individuals has not been fully explored.

methodsOne hundered ninety-two HIV-infected individuals aged 18-64 years were stratified by CD4 cell count (<200 cells/mL or ≥200 cells/mL) and randomized to receive 2 doses of 15 μg or 30 μg HA 2009 H1N1 vaccine 21 days apart. Hemagglutination inhibition (HAI) and microneutralization (MN) antibodies were measured on days 0, 10, 21, 31, 42, and 201.

resultsRecipients of 30 μg HA had significantly higher HAI geometric mean titers (GMTs), compared with recipients of 15 μg HA on days 10 (139.0 vs 51.9; P = .01), 21 (106.7 vs 51.9; P = .001), and 31 (130.0 vs 73.7; P = .03) but not on days 42 (91.8 vs 61.6; P = .11) and 201 (43.0 vs 27.0; P = .08). When analyzed by CD4 cell count stratum, HAI GMTs were significantly higher among 30 μg HA recipients than among 15 μg HA in the CD4 cell count <200 cells/mL stratum on days 21 and 31 and the MN GMTs on days 10, 21, 31, and 42 (P < .05). In the CD4 cell count ≥200 cells/mL stratum, MN GMTs were significantly higher among recipients of 30 μg HA than among recipients of 15 μg HA on day 10 (P = .03).

conclusionIncreasing the HA dose of the 2009 H1N1 vaccine improves the vaccine's immunogenicity in HIV-infected individuals. CLINICAL TRIALS REGISTRATION: NCT00992433.

Indexed as

AdolescentAdultAntigens, ViralCD4 Lymphocyte CountFemaleHemagglutination Inhibition TestsHemagglutininsHIV-1HIV InfectionsHumansInfluenza A Virus, H1N1 SubtypeInfluenza VaccinesMaleMiddle AgedTime FactorsVaccines, InactivatedAntigens, ViralHemagglutininsInfluenza VaccinesVaccines, Inactivated

Identifiers

PMID22275399
PMCPMC3274370
OpenAlexW2159266143

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.