Evidence map›Paper›PMID 23633407›Full record

Trial reportThe Journal of infectious diseases2013

Prime-boost interval matters: a randomized phase 1 study to identify the minimum interval necessary to observe the H5 DNA influenza vaccine priming effect.

Julie E Ledgerwood, Kathryn Zephir, Zonghui Hu, Chih-Jen Wei, Leejah Chang, Mary E Enama, Cynthia S Hendel, Sandra Sitar, Robert T Bailer, Richard A Koup and 4 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 94 papers.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed
9.8field-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.

NCT01086657 phase1completednot on this map

VRC 310: An Open-Label, Randomized Ph I: Healthy Adults of Prime-Boost Intervals w/Monovalent Influenza Virion (H5N1) Vaccine, A/Indonesia/05/2005 (Sanofi Pasteur, Inc), Administered Alone or Following Recombinant H5 DNA Vaccine

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2010 to 2011Enrolled64ConditionsInfluenza A Virus, H5N1 SubtypeArmsVRC-AVIDNA036-00-VP, Monovalent Influenza Subunit Virion (Inactive H5N1) Vaccine
NCT02206464 phase1completednot on this mapstarted 2014, after this paper: background citation

VRC 315: A Phase I Open-Label, Randomized Study of H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boost

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2014 to 2016Enrolled30ConditionsInfluenzaArmsA/Shanghai/02/2013 (H7N9) MIV, VRC-FLUDNA071-00-VP
NCT04579250 phase1completednot on this mapstarted 2020, after this paper: background citation

VRC 323: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, in Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2020 to 2022Enrolled25ConditionsInfluenzaArmsVRC-FLUNPF0103-00-VP (H10ssF-6473)
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 131 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Efficacy and Safety of Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) in Older Adults Over 2 RSV Seasons.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. Article
  20. Article

34 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

14 authors at 1 institution in 1 country.

Julie E LedgerwoodVaccine Research Center, National Institute ofAllergy and Infectious Diseases, National Institutes of Health, Bethesda,MD 20892, USA. ledgerwood@mail.nih.gov
Kathryn Zephir
Zonghui Hu
Chih-Jen Wei
Leejah Chang
Mary E Enama
Cynthia S Hendel
Sandra Sitar
Robert T Bailer
Richard A Koup
John R Mascola
Gary J Nabel
Barney S Graham
VRC 310 Study Team
National Institutes of Health · 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

backgroundH5 DNA priming was previously shown to improve the antibody response to influenza A(H5N1) monovalent inactivated vaccine (MIV) among individuals for whom there was a 24-week interval between prime and boost receipt. This study defines the shortest prime-boost interval associated with an improved response to MIV.

methodsWe administered H5 DNA followed by MIV at intervals of 4, 8, 12, 16, or 24 weeks and compared responses to that of 2 doses of MIV (prime-boost interval, 24 weeks).

resultsH5 DNA priming with an MIV boost ≥12 weeks later showed an improved response, with a positive hemagglutination inhibition (HAI) titer in 91% of recipients (geometric mean titer [GMT], 141-206), compared with 55%-70% of recipients with an H5 DNA and MIV prime-boost interval of ≤8 weeks (GMT, 51-70) and 44% with an MIV-MIV prime-boost interval of 24 weeks (GMT, 27).

conclusionH5 DNA priming enhances antibody responses after an MIV boost when the prime-boost interval is 12-24 weeks. Clinical Trials Registration. NCT01086657.

Indexed as

AdolescentAdultAntibodies, ViralFemaleHemagglutination Inhibition TestsHemagglutinin Glycoproteins, Influenza VirusHumansImmunization, SecondaryInfluenza VaccinesMaleMiddle AgedTime FactorsVaccines, DNAVaccines, InactivatedYoung AdultAntibodies, Viralhemagglutinin, avian influenza A virusHemagglutinin Glycoproteins, Influenza VirusInfluenza VaccinesVaccines, DNAVaccines, InactivatedAvian influenzaboost intervalDNA vaccineH5N1hemagglutination inhibition

Identifiers

PMID23633407
PMCPMC3699006
OpenAlexW2165908776

What OpenQuestion holds

Textmetadata
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.