Evidence map›Paper›PMID 38181048›Full record

Trial reportThe Journal of infectious diseases2024

Metabolomic Signatures Differentiate Immune Responses in Avian Influenza Vaccine Recipients.

Leigh M Howard, Travis L Jensen, Johannes B Goll, Casey E Gelber, Matthew D Bradley, Stacy D Sherrod, Kristen L Hoek, Sandra Yoder, Natalia Jimenez-Truque, Kathryn Edwards and 1 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01573312 (A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered With and Without AS03 Adjuvant), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.2field-weighted citation impact, top 23% 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.

NCT01573312 phase1completednot on this map

A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered With and Without AS03 Adjuvant: Standard & Systems Biology Analyses

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2012 to 2014Enrolled20ConditionsInfluenzaArmsASO3 Adjuvant, Influenza A/H5N1 Vaccine
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. Review
  3. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  4. Future Goals and Long-term Vision of the Infectious Diseases Clinical Research Consortium/Vaccine and Treatment Evaluation Unit Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  5. 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

11 authors at 2 institutions in 1 country.

Leigh M HowardVanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine and Medical Center, Nashville, Tennessee, USA.ORCID 0000-0003-4301-7235
Travis L JensenBiomedical Data Science and Bioinformatics Department, The Emmes Company, LLC, Rockville, Maryland, USA.
Johannes B GollBiomedical Data Science and Bioinformatics Department, The Emmes Company, LLC, Rockville, Maryland, USA.
Casey E GelberBiomedical Data Science and Bioinformatics Department, The Emmes Company, LLC, Rockville, Maryland, USA.
Matthew D BradleyBiomedical Data Science and Bioinformatics Department, The Emmes Company, LLC, Rockville, Maryland, USA.
Stacy D SherrodCenter for Innovative Technology, Department of Chemistry, Vanderbilt University, Nashville, Tennessee, USA.ORCID 0000-0002-2346-230X
Kristen L HoekVanderbilt Institute for Infection, Inflammation and Immunity, Vanderbilt University School of Medicine and Medical Center, Nashville, Tennessee, USA.
Sandra YoderVanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine and Medical Center, Nashville, Tennessee, USA.
Natalia Jimenez-TruqueVanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine and Medical Center, Nashville, Tennessee, USA.ORCID 0000-0002-3065-9127
Kathryn EdwardsVanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine and Medical Center, Nashville, Tennessee, USA.
C Buddy CreechVanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine and Medical Center, Nashville, Tennessee, USA.ORCID 0000-0002-8276-9053
Vanderbilt University · USEmmes (United States) · US

Funding

Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
National Institute of Allergy and Infectious DiseasesNCATS NIH HHS UL1 TR002243NIAID NIH HHS HHSN272201300023CNIAID NIH HHS HHSN272201300023INIH HHS HHSN272201300023I
6 · The paper itself

Abstract

backgroundAvian influenza viruses pose significant risk to human health. Vaccines targeting the hemagglutinin of these viruses are poorly immunogenic without the use of adjuvants.

methodsTwenty healthy men and women (18-49 years of age) were randomized to receive 2 doses of inactivated influenza A/H5N1 vaccine alone (IIV) or with AS03 adjuvant (IIV-AS03) 1 month apart. Urine and serum samples were collected on day 0 and on days 1, 3, and 7 following first vaccination and subjected to metabolomics analyses to identify metabolites, metabolic pathways, and metabolite clusters associated with immunization.

resultsSeventy-three differentially abundant (DA) serum and 88 urine metabolites were identified for any postvaccination day comparison. Pathway analysis revealed enrichment of tryptophan, tyrosine, and nicotinate metabolism in urine and serum among IIV-AS03 recipients. Increased urine abundance of 4-vinylphenol sulfate on day 1 was associated with serologic response based on hemagglutination inhibition responses. In addition, 9 DA urine metabolites were identified in participants with malaise compared to those without.

conclusionsOur findings suggest that tryptophan, tyrosine, and nicotinate metabolism are upregulated among IIV-AS03 recipients compared with IIV alone. Metabolites within these pathways may serve as measures of immunogenicity and may provide mechanistic insights for adjuvanted vaccines. CLINICAL TRIALS REGISTRATION: NCT01573312.

Indexed as

Influenza, HumanInfluenza VaccinesMetabolomicsAdjuvants, ImmunologicAdolescentAdultAntibodies, ViralFemaleHumansInfluenza A Virus, H5N1 SubtypeMaleMetabolomeMiddle AgedTryptophanTyrosineVaccinationAdjuvants, ImmunologicAntibodies, ViralInfluenza VaccinesTryptophanTyrosineVaccines, InactivatedadjuvantadversomicsAS03influenzametabolomicsvaccination

Identifiers

PMID38181048
PMCPMC11420767
OpenAlexW4390604467

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.