Evidence map›Paper›PMID 23239968›Full record

Trial reportPloS one2012

A randomized clinical trial of an inactivated avian influenza A (H7N7) vaccine.

Robert B Couch, Shital M Patel, Chianti L Wade-Bowers, Diane Niño

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

Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00546585 (A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H7N7 Vaccine in Healthy Adults), which is not on this map. Cited by 79 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 5 pooled it
10.9field-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.

NCT00546585 phase1 / phase2completednot on this map

A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H7N7 Vaccine in Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2008 to 2009Enrolled126ConditionsInfluenzaArmsInfluenza A/H7N7 Vaccine, Placebo
3 · Its place in the literature

Who cites it

79 citing papers in PubMed, 5 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Vaccines for preventing influenza in healthy adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Pooled it
  6. Trial
  7. A Phase 1/2 Dose-Ranging Safety and Immunogenicity Study of mRNA-Based Candidate Pandemic Influenza Vaccines in Healthy Adults.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article

19 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

4 authors at 1 institution in 1 country.

Robert B CouchDepartment of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, United States of America. rcouch@bcm.edu
Shital M Patel
Chianti L Wade-Bowers
Diane Niño
Baylor College of Medicine · US

Funding

VIRAL RESPIRATORY PATHOGENS RESEARCH UNIT (VRPRU)N01AI30039 · NIAID · BAYLOR COLLEGE OF MEDICINE · PI COUCH, ROBERT B · 2007 to 2012
$12.0M
VIRAL RESPIRATORY PATHOGENS RESEARCH UNIT /VRPRU/-266030039-266030039N01AI030039 · NIAID · BAYLOR COLLEGE OF MEDICINE INC · PI COUCH, ROBERT B. · 2003 to 2006
–
NIAID NIH HHS N01 AI030039NIAID NIH HHS N01 AI 30039
6 · The paper itself

Abstract

backgroundConcern for a pandemic caused by a newly emerged avian influenza A virus has led to clinical trials with candidate vaccines as preparation for such an event. Most trials have involved vaccines for influenza A (H5N1), A (H7N7) or A (H9N2).

objectiveTo evaluate dosage-related safety and immunogenicity of an inactivated influenza A (H7N7) vaccine in humans.

designOne hundred twenty-five healthy young adults were randomized to receive two doses intramuscularly of placebo or 7.5, 15, 45 or 90 µg of HA of an inactivated subunit influenza A (H7N7) vaccine (25 per group), four weeks apart. Reactogenicity was evaluated closely for one week and for any adverse effect for six months after each dose. Serum hemagglutination-inhibiting and neutralizing antibody responses were determined four weeks after each dose and at six months.

resultsReactogenicity evaluations indicated the vaccinations were well tolerated. Only one subject developed a ≥4-fold serum hemagglutination-inhibition (HAI) antibody response and a final titer of ≥1:40 four weeks after dose two and only five subjects developed a neutralizing antibody rise and a final titer of ≥1:40 in tests performed at a central laboratory. Four of the five were given the 45 or 90 µg HA dosage. A more sensitive HAI assay at the study site revealed a dose-response with increasing HA dosage but only 36% in the 90 µg HA group developed a ≥4-fold rise in antibody in this test and only one of these achieved a titer of ≥1:32.

conclusionThis inactivated subunit influenza A (H7N7) vaccine was safe but poorly immunogenic in humans. TRIALS REGISTRATION: ClinicalTrials.gov NCT00546585.

Indexed as

Influenza, HumanInfluenza in BirdsAdolescentAdultAnimalsAntibodies, ViralAntibody FormationBirdsFemaleHumansInfluenza A Virus, H7N7 SubtypeInfluenza VaccinesMaleVaccines, InactivatedAntibodies, ViralInfluenza VaccinesVaccines, Inactivated

Identifiers

PMID23239968
PMCPMC3519847
OpenAlexW2067253046

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.