Evidence map›Paper›PMID 22956656›Full record

Trial reportClinical and vaccine immunology : CVI2012

Influenza virus h5 DNA vaccination is immunogenic by intramuscular and intradermal routes in humans.

J E Ledgerwood, Z Hu, I J Gordon, G Yamshchikov, M E Enama, S Plummer, R Bailer, M B Pearce, T M Tumpey, R A Koup and 4 more

Open access · diamondAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
6.0field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 57 citations in OpenAlex.

  1. Trial
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  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. A Review of DNA Vaccines Against Influenza.Frontiers in immunology · 2018
    Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Advances in the development of influenza virus vaccines.Nature reviews. Drug discovery · 2015
    Review
  19. Article
  20. 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 at 2 institutions in 1 country.

J E LedgerwoodVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA. ledgerwood@mail.nih.gov
Z Hu
I J Gordon
G Yamshchikov
M E Enama
S Plummer
R Bailer
M B Pearce
T M Tumpey
R A Koup
J R Mascola
G J Nabel
B S Graham
VRC 304 and VRC 305 Study Teams
National Institutes of Health · USNational Center for Immunization and Respiratory Diseases · US

Funding

Influenza and Emerging and Re-emerging Infectious Diseases Vaccine StudiesZIAAI005047 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI DROPULIC, LESIA K · 2009 to 2025
$58.4M
NIAID Vaccine Immune T cell and Antibody Laboratory CoreZICAI005123 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KOUP, RICHARD A · 2013 to 2016
$15.1M
Immunology CoreZICAI005124 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KOUP, RICHARD A · 2013 to 2016
$6.4M
Intramural NIH HHS
6 · The paper itself

Abstract

Avian influenza virus causes outbreaks in domestic and wild birds around the world, and sporadic human infections have been reported. A DNA vaccine encoding hemagglutinin (HA) protein from the A/Indonesia/5/05 (H5N1) strain was initially tested in two randomized phase I clinical studies. Vaccine Research Center study 304 (VRC 304) was a double-blinded study with 45 subjects randomized to placebo, 1 mg of vaccine, or 4 mg of vaccine treatment groups (n = 15/group) by intramuscular (i.m.) Biojector injection. VRC 305 was an open-label study to evaluate route, with 44 subjects randomized to intradermal (i.d.) injections of 0.5 mg by needle/syringe or by Biojector or 1 mg delivered as two 0.5-mg Biojector injections in the same deltoid or as 0.5 mg in each deltoid (n = 11/group). Injections were administered at weeks 0, 4, and 8 in both studies. Antibody responses to H5 were assessed by hemagglutination inhibition (HAI) assay, enzyme-linked immunosorbent assay (ELISA), and neutralization assay, and the H5 T cell responses were assessed by enzyme-linked immunospot and intracellular cytokine staining assays. There were no vaccine-related serious adverse events, and the vaccine was well tolerated in all groups. At 1 mg, i.d. vaccination compared to i.m. vaccination induced a greater frequency and magnitude of response by ELISA, but there were no significant differences in the frequency or magnitude of response between the i.d. and i.m. routes in the HAI or neutralization assays. T cell responses were more common in subjects who received the 1- or 4-mg dose i.m. These studies demonstrated that the DNA vaccine encoding H5 is safe and immunogenic and served to define the proper dose and route for further studies. The i.d. injection route did not offer a significant advantage over the i.m. route, and no difference was detected by delivery to one site versus splitting the dose between two sites for i.d. vaccine administration. The 4-mg dose (i.m) was further investigated in prime-boost regimens.

Indexed as

AdultAntibodies, ViralCytokinesDouble-Blind MethodEnzyme-Linked Immunosorbent AssayEnzyme-Linked Immunospot AssayFemaleHemagglutination Inhibition TestsHemagglutinin Glycoproteins, Influenza VirusHumansInfluenza, HumanInfluenza VaccinesInjections, IntradermalInjections, IntramuscularMaleMiddle AgedAntibodies, ViralCytokineshemagglutinin, avian influenza A virusHemagglutinin Glycoproteins, Influenza VirusInfluenza VaccinesPlacebosVaccines, DNA

Identifiers

PMID22956656
PMCPMC3491556
OpenAlexW2136505097

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.