Evidence map›Paper›PMID 25950433›Full record

Trial reportPloS one2015

DNA priming for seasonal influenza vaccine: a phase 1b double-blind randomized clinical trial.

Julie E Ledgerwood, Abbie R Bellamy, Robert Belshe, David I Bernstein, Srilatha Edupuganti, Shital M Patel, Phyllis Renehan, Thad Zajdowicz, Richard Schwartz, Richard Koup and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01498718 (Double-Blind, Randomized Phase 1b Study of 2011/12 Influenza Investigational DNA Vaccine, VRC-FLUDNA061-00-VP, Followed by 2012/13 Trivalent Inactivated Vaccine), 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
1.5field-weighted citation impact, top 18% 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.

NCT01498718 phase1completednot on this map

Double-Blind, Randomized Phase 1b Study of 2011/12 Influenza Investigational DNA Vaccine, VRC-FLUDNA061-00-VP, Followed by 2012/13 Trivalent Inactivated Vaccine (TIV) Compared to 2012/13 TIV Alone in Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2011 to 2013Enrolled131ConditionsInfluenzaArmsDNA vaccine, TIV
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. A Review of DNA Vaccines Against Influenza.Frontiers in immunology · 2018
    Review
  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

17 authors at 7 institutions in 1 country.

Julie E LedgerwoodVaccine Research Center, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Abbie R BellamyThe EMMES Corporation, Rockville, Maryland, United States of America.
Robert BelsheEdward A. Daisy Research Center, Saint Louis University, Saint Louis, Missouri, United States of America.
David I BernsteinCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio, United States of America.
Srilatha EdupugantiDepartment of Medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, United States of America.
Shital M PatelDepartment of Medicine and Molecular Virology and Microbiology, Baylor College of Medicine Houston, Texas, United States of America.
Phyllis RenehanThe EMMES Corporation, Rockville, Maryland, United States of America.
Thad ZajdowiczThe EMMES Corporation, Rockville, Maryland, United States of America.
Richard SchwartzVaccine Research Center, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Richard KoupVaccine Research Center, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Robert T BailerVaccine Research Center, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Galina V YamshchikovVaccine Research Center, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Mary E EnamaVaccine Research Center, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Uzma SarwarVaccine Research Center, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Brenda LarkinVaccine Research Center, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
Barney S GrahamVaccine Research Center, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.
VRC 701 study team
National Institute of Allergy and Infectious Diseases · USNational Institutes of Health · USEmmes (United States) · USBaylor College of Medicine · USCincinnati Children's Hospital Medical Center · USEmory University · USSaint Louis University · 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
Testing of Blood Samples for Immune Response and Vaccine ResearchZIAAI005073 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI KOUP, RICHARD A · 2009 to 2025
$23.4M
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 HHSNIAID NIH HHS HHSN272201000049I
6 · The paper itself

Abstract

backgroundThe efficacy of current influenza vaccines is limited in vulnerable populations. DNA vaccines can be produced rapidly, and may offer a potential strategy to improve vaccine immunogenicity, indicated by studies with H5 influenza DNA vaccine prime followed by inactivated vaccine boost.

methodsFour sites enrolled healthy adults, randomized to receive 2011/12 seasonal influenza DNA vaccine prime (n=65) or phosphate buffered saline (PBS) (n=66) administered intramuscularly with Biojector. All subjects received the 2012/13 seasonal inactivated influenza vaccine, trivalent (IIV3) 36 weeks after the priming injection. Vaccine safety and tolerability was the primary objective and measurement of antibody response by hemagglutination inhibition (HAI) was the secondary objective.

resultsThe DNA vaccine prime-IIV3 boost regimen was safe and well tolerated. Significant differences in HAI responses between the DNA vaccine prime and the PBS prime groups were not detected in this study.

conclusionWhile DNA priming significantly improved the response to a conventional monovalent H5 vaccine in a previous study, it was not effective in adults using seasonal influenza strains, possibly due to pre-existing immunity to the prime, unmatched prime and boost antigens, or the lengthy 36 week boost interval. Careful optimization of the DNA prime-IIV3 boost regimen as related to antigen matching, interval between vaccinations, and pre-existing immune responses to influenza is likely to be needed in further evaluations of this vaccine strategy. In particular, testing this concept in younger age groups with less prior exposure to seasonal influenza strains may be informative.

trial registrationClinicalTrials.gov NCT01498718.

Indexed as

AdultAgedDouble-Blind MethodFemaleHumansInfluenza A Virus, H5N1 SubtypeInfluenza, HumanInfluenza VaccinesInjections, IntramuscularMaleMiddle AgedVaccines, DNAVaccines, InactivatedYoung AdultInfluenza VaccinesVaccines, DNAVaccines, Inactivated

Identifiers

PMID25950433
PMCPMC4423975
OpenAlexW220788000

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.