Evidence map›Paper›PMID 27129426›Full record

Trial reportVaccine2016

Immunogenicity and safety of high-dose trivalent inactivated influenza vaccine compared to standard-dose vaccine in children and young adults with cancer or HIV infection.

Hana Hakim, Kim J Allison, Lee-Ann Van de Velde, Li Tang, Yilun Sun, Patricia M Flynn, Jonathan A McCullers

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
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

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Comparison of Two High-Dose Versus Two Standard-Dose Influenza Vaccines in Adult Allogeneic Hematopoietic Cell Transplant Recipients.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Trial
  3. Article
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Factors influencing the immunogenicity of influenza vaccines.Human vaccines & immunotherapeutics · 2021
    Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Seasonal influenza vaccine in immunocompromised persons.Human vaccines & immunotherapeutics · 2018
    Review
  18. Review
  19. Article
  20. Influenza vaccines: Evaluation of the safety profile.Human vaccines & immunotherapeutics · 2018
    Review
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

7 authors at 2 institutions in 1 country.

Hana HakimDepartment of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA. Electronic address: Hana.Hakim@stjude.org.
Kim J AllisonDepartment of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA.
Lee-Ann Van de VeldeDepartment of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA.
Li TangDepartment of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.
Yilun SunDepartment of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA.
Patricia M FlynnDepartment of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA; Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN, USA; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.
Jonathan A McCullersDepartment of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA; Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN, USA. Electronic address: jmccullers@uthsc.edu.
St. Jude Children's Research Hospital · USUniversity of Tennessee Health Science Center · US

Funding

Viral Vector Technology (VVTSR)P30CA021765 · NCI · ST. JUDE CHILDREN'S RESEARCH HOSPITAL · PI CHARLES ROBERTS · 1985 to 2026
$166.9M
NCI NIH HHS P30 CA021765
6 · The paper itself

Abstract

backgroundApproaches to improve the immune response of immunocompromised patients to influenza vaccination are needed.

methodsChildren and young adults (3-21 years) with cancer or HIV infection were randomized to receive 2 doses of high-dose (HD) trivalent influenza vaccine (TIV) or of standard-dose (SD) TIV. Hemagglutination inhibition (HAI) antibody titers were measured against H1, H3, and B antigens after each dose and 9 months later. Seroconversion was defined as ≥4-fold rise in HAI titer comparing pre- and post-vaccine sera. Seroprotection was defined as a post-vaccine HAI titer ≥1:40. Reactogenicity events (RE) were solicited using a structured questionnaire 7 and 14 days after each dose of vaccine, and adverse events by medical record review for 21 days after each dose of vaccine.

resultsEighty-five participants were enrolled in the study; 27 with leukemia, 17 with solid tumor (ST), and 41 with HIV. Recipients of HD TIV had significantly greater fold increase in HAI titers to B antigen in leukemia group and to H1 antigen in ST group compared to SD TIV recipients. This increase was not documented in HIV group. There were no differences in seroconversion or seroprotection between HD TIV and SD TIV in all groups. There was no difference in the percentage of solicited RE in recipients of HD TIV (54% after dose 1 and 38% after dose 2) compared to SD TIV (40% after dose 1 and 20% after dose 2, p=0.27 and 0.09 after dose 1 and 2, respectively).

conclusionHD TIV was more immunogenic than SD TIV in children and young adults with leukemia or ST, but not with HIV. HD TIV was safe and well-tolerated in children and young adults with leukemia, ST, or HIV.

Indexed as

AdolescentAntibodies, ViralChildChild, PreschoolFemaleHemagglutination Inhibition TestsHIV InfectionsHumansImmunization, SecondaryInfluenza, HumanInfluenza VaccinesLeukemiaMaleNeoplasmsYoung AdultAntibodies, ViralInfluenza VaccinesCancerHigh doseHIVImmune responseInfluenza vaccineSafety

Identifiers

PMID27129426
PMCPMC4899146
OpenAlexW2342684570

What OpenQuestion holds

Textmetadata
LicenceTDM
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.