Evidence map›Paper›PMID 35465983›Full record

Trial reportVaccine2022

Safety and immunogenicity of monovalent H7N9 influenza vaccine with AS03 adjuvant given sequentially or simultaneously with a seasonal influenza vaccine: A randomized clinical trial.

Justin R Ortiz, Paul W Spearman, Paul A Goepfert, Kaitlyn Cross, C Buddy Creech, Wilbur H Chen, Susan Parker, Edgar T Overton, Michelle Dickey, Heather L Logan and 2 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03318315 (A Phase II Study in Healthy Adults), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.6field-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.

NCT03318315 phase2completednot on this map

A Phase II Study in Healthy Adults (19-64 Years of Age) to Assess the Safety, Reactogenicity and Immunogenicity of Sequential or Simultaneous Intramuscular Administration of an AS03-adjuvanted A/H7N9 Inactivated Influenza Vaccine With Seasonal Influenza Vaccine

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2018 to 2019Enrolled149ConditionsAvian Influenza, Influenza, Influenza ImmunisationArmsAS03, Inactivated influenza H7N9 vaccine, Influenza Virus Quadrivalent Inactivated Vaccine, Phosphate Buffered Saline (PBS) diluent
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  7. 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
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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

12 authors at 6 institutions in 1 country.

Justin R OrtizCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: jortiz@som.umaryland.edu.
Paul W SpearmanCincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH, USA.
Paul A GoepfertDivision of Infectious Diseases, University of Alabama at Birmingham, School of Medicine, Birmingham, AL, USA.
Kaitlyn CrossThe Emmes Company, Rockville, MD, USA.
C Buddy CreechVanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, TN, USA.
Wilbur H ChenCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Susan ParkerCincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH, USA.
Edgar T OvertonDivision of Infectious Diseases, University of Alabama at Birmingham, School of Medicine, Birmingham, AL, USA.
Michelle DickeyCincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH, USA.
Heather L LoganDivision of Infectious Diseases, University of Alabama at Birmingham, School of Medicine, Birmingham, AL, USA.
Ashley WegelThe Emmes Company, Rockville, MD, USA.
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
University of Alabama at Birmingham · USUniversity of Maryland, Baltimore · USCincinnati Children's Hospital Medical Center · USEmmes (United States) · USUniversity of Cincinnati · USVanderbilt University Medical Center · 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
Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required) - Moderna Pediatric StudyUM1AI148372 · NIAID · CINCINNATI CHILDRENS HOSP MED CTR · PI Robert Wilson Frenck · 2020 to 2026
$20.5M
Dynamics of the protective vaccine-induced human influenza neuraminidase B cell responseR01AI145332 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI KOBIE, JAMES J, MARTINEZ-SOBRIDO, LUIS · 2019 to 2022
$3.0M
NCATS NIH HHS UL1 TR003098NIAID NIH HHS 75N93021C00012NIAID NIH HHS HHSN272200800057CNIAID NIH HHS HHSN272201200003INIAID NIH HHS HHSN272201300016CNIAID NIH HHS HHSN272201300016INIAID NIH HHS HHSN272201300023CNIAID NIH HHS HHSN272201300023INIAID NIH HHS R01 AI145332NIAID NIH HHS UM1 AI148372
6 · The paper itself

Abstract

backgroundInfluenza A/H7N9 viruses have pandemic potential.

methodsWe conducted an open-label, randomized, controlled trial of AS03-adjuvanted 2017 inactivated influenza A/H7N9 vaccine (H7N9 IIV) in healthy adults. Group 1 received H7N9 IIV and seasonal quadrivalent influenza vaccine (IIV4) simultaneously, followed by H7N9 IIV three weeks later. Group 2 received IIV4 alone and then two doses of H7N9 IIV at three-week intervals. Group 3 received one dose of IIV4. We used hemagglutination inhibition (HAI) and microneutralization (MN) assays to measure geometric mean titers and seroprotection (≥1:40 titer) to vaccine strains and monitored for safety.

resultsAmong 149 subjects, seroprotection by HAI three weeks after H7N9 IIV dose 2 was 51% (95 %CI 37%-65%) for Group 1 and 40% (95 %CI 25%-56%) for Group 2. Seroprotection by MN at the same timepoint was 84% (95 %CI 72%-93%) for Group 1 and 74% (95 %CI 60%-86%) for Group 2. By 180 days after H7N9 IIV dose 2, seroprotection by HAI or MN was low for Groups 1 and 2. Responses measured by HAI and MN against each IIV4 strain three weeks after IIV4 vaccination were similar in all groups. Solicited local and systemic reactions were similar after a single vaccination, while those receiving simultaneous H7N9 and IIV4 had slightly more reactogenicity. There were no serious adverse events or medically-attended adverse events related to study product receipt.

conclusionsAdjuvanted H7N9 IIV was modestly immunogenic whether administered simultaneously or sequentially with IIV4, though responses declined by 180 days. IIV4 was immunogenic regardless of schedule. CLINICAL TRIALS REGISTRATION: NCT03318315.

Indexed as

Influenza A Virus, H7N9 SubtypeInfluenza, HumanInfluenza in BirdsInfluenza VaccinesAdjuvants, ImmunologicAdultalpha-TocopherolAnimalsAntibodies, ViralDrug CombinationsHemagglutination Inhibition TestsHumansImmunogenicity, VaccinePolysorbatesSeasonsSqualeneAdjuvants, Immunologicalpha-TocopherolAntibodies, ViralAS03 adjuvantDrug CombinationsInfluenza VaccinesPolysorbatesSqualeneVaccines, Inactivated

Identifiers

PMID35465983
PMCPMC9897630
OpenAlexW4224271834

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.