Evidence map›Paper›PMID 37466221›Full record

Trial reportThe Journal of infectious diseases2024

Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial.

Hana M El Sahly, Inci Yildirim, Sharon E Frey, Patricia Winokur, Lisa A Jackson, David I Bernstein, C Buddy Creech, Wilbur H Chen, Richard E Rupp, Jennifer A Whitaker and 10 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
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 NCT03738241 (A Phase II Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Dose of 2017 A/H7N9 Inactivated Influenza Vaccine), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.5field-weighted citation impact, top 17% 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.

NCT03738241 phase2completednot on this map

A Phase II Study to Assess the Safety, Reactogenicity and Immunogenicity of a Single Dose of 2017 A/H7N9 Inactivated Influenza Vaccine (IIV) Administered Intramuscularly With or Without AS03 Adjuvant in 2013 A/H7N9 IIV Primed or A/H7 IIV Naïve Subjects

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2018 to 2020Enrolled304ConditionsAvian Influenza, Influenza ImmunisationArmsA/H7N9, AS03, Phosphate Buffered Saline (PBS) diluent
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
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  7. From Yesterday to Tomorrow: How Vaccine Platforms Have Shaped the Vaccine and Treatment Evaluation Units.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  8. 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
  9. 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
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

20 authors at 10 institutions in 1 country.

Hana M El SahlyDepartment of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.ORCID 0000-0003-0489-0074
Inci YildirimDepartment of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, USA.
Sharon E FreyDepartment of Internal Medicine, Saint Louis University School of Medicine, St Louis, Missouri, USA.
Patricia WinokurDepartment of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.
Lisa A JacksonKaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
David I BernsteinCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio, USA.
C Buddy CreechDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Wilbur H ChenCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Richard E RuppSealy Institute for Vaccine Sciences, University of Texas Medical Branch, Galveston, Texas, USA.
Jennifer A WhitakerDepartment of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Varun PhadkeThe Hope Clinic of Emory University, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, USA.
Daniel F HoftDepartment of Internal Medicine, Saint Louis University School of Medicine, St Louis, Missouri, USA.
Dilek InceDepartment of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.ORCID 0000-0001-5446-3789
Rebecca C BradyCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio, USA.
Kathryn M EdwardsDepartment of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Justin R OrtizCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.
Megan A BermanSealy Institute for Vaccine Sciences, University of Texas Medical Branch, Galveston, Texas, USA.
Julia WeissThe Emmes Company, Rockville, Maryland, USA.
Ashley WegelThe Emmes Company, Rockville, Maryland, USA.
DMID 17-0090 Study Group
Baylor College of Medicine · USCincinnati Children's Hospital Medical Center · USEmmes (United States) · USEmory University · USSaint Louis University · USThe University of Texas Medical Branch at Galveston · USUniversity of Iowa · USUniversity of Maryland, Baltimore · USVanderbilt University Medical Center · USKaiser Permanente Washington Health Research Institute · US

Funding

Statistical Data Coordinating Center: Monkeypox Clinical Research Support75N93021C00012 · NIAID · THE EMMES COMPANY, LLC · PI EWELL, MARIAN · 2021 to 2025
$150.3M
QAQC Johns Hopkins Institute for Clinical and Translational ResearchUL1TR003098 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2019 to 2023
$57.7M
VTEU SupplementUM1AI148689 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI Karen L. Kotloff · 2020 to 2026
$52.7M
Vaccine and Treatment Evaluation Unit at Saint Louis University - DMID 20-0034UM1AI148685 · NIAID · SAINT LOUIS UNIVERSITY · PI Daniel F. Hoft · 2020 to 2026
$34.6M
HHSNCATS NIH HHS 1UL1TR003098NCATS NIH HHS UL1 TR003098NIAID NIH HHS 75N93021C00012NIAID NIH HHS UM1 AI148685NIAID NIH HHS UM1 AI148689NIH HHS HHSN272201300015I
6 · The paper itself

Abstract

backgroundInfluenza A (H7N9) has caused multiple disease waves with evidence of strain diversification. Optimal influenza A (H7N9) prime-boost vaccine strategies are unknown.

methodsWe recruited participants who had received monovalent inactivated A/Shanghai/2/2013 (H7N9) vaccine (MIV) approximately 5 years earlier, as follows: MIV with MF59 (MF59 × 2 group), MIV with AS03 (AS03 × 2 group), unadjuvanted MIV (No Adj group), MIV with MF59 or AS03 followed by unadjuvanted MIV (Adjx1 group), and A/H7-naive (unprimed group). Participants were randomized to receive 1 dose of AS03-adjuvanted or unadjuvanted A/Hong Kong/125/2017 (H7N9) MIV and were followed for safety and immunogenicity using hemagglutination inhibition (HAI) and neutralizing antibody assays.

resultsWe enrolled 304 participants: 153 received the adjuvanted boost and 151 received the unadjuvanted boost. At 21 days postvaccination, the proportion of participants with HAI antibody titers against the boosting vaccine strain of ≥40 in the adjuvanted and unadjuvanted arms, respectively, were 88% and 49% in MF59 × 2 group, 89% and 75% in AS03 × 2 group, 59% and 20% in No Adj group, 94% and 55% in Adjx1group, and 9% and 11% in unprimed group.

conclusionsSerologic responses to a heterologous A(H7N9) MIV boost were highest in participants primed and boosted with adjuvant-containing regimens. CLINICAL TRIALS REGISTRATION: NCT03738241.

Indexed as

Influenza A Virus, H7N9 SubtypeInfluenza, HumanInfluenza VaccinesAdjuvants, ImmunologicAntibodies, ViralChinaHemagglutination Inhibition TestsHumansImmunogenicity, VaccinePolysorbatesSqualeneAdjuvants, ImmunologicAntibodies, ViralInfluenza VaccinesMF59 oil emulsionPolysorbatesSqualeneavian influenzainfluenza A(H7N9)pandemicpandemic preparedness

Identifiers

PMID37466221
PMCPMC10873179
OpenAlexW4384665075

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.