Evidence map›Paper›PMID 39756216›Full record

Trial reportVaccine2025

Anti-neuraminidase and anti-hemagglutinin stalk responses to different influenza a(H7N9) vaccine regimens.

Hana M El Sahly, Evan J Anderson, Lisa A Jackson, Kathleen M Neuzil, Robert L Atmar, David I Bernstein, Wilbur H Chen, C Buddy Creech, Sharon E Frey, Paul Goepfert and 20 more

4 registry-linked trialsAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

NCT03312231 phase2completednot on this map

A Phase II Study in Healthy Adults 19 Years and Older to Assess the Safety, Reactogenicity and Immunogenicity of a Sanofi Pasteur A/H7N9 Inactivated Influenza Vaccine Administered Intramuscularly With or Without AS03 Adjuvant

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2018 to 2019Enrolled720ConditionsAvian Influenza, Influenza ImmunisationArmsAS03, Inactivated influenza H7N9 vaccine, Phosphate Buffered Saline (PBS) diluent
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
NCT03589807 phase2completednot on this map

A Phase II Study to Assess the Safety, Reactogenicity and Immunogenicity of Different Prime-Boost Vaccination Schedules of 2013 and 2017 A/H7N9 Inactivated Influenza Vaccines Administered Intramuscularly With or Without AS03 Adjuvant in Healthy Adults 19-50 Years of Age

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2018 to 2020Enrolled180ConditionsAvian Influenza, Influenza ImmunisationArmsA/H7N9, AS03, Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013, Phosphate Buffered Saline (PBS) diluent
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

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. 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

30 authors.

Hana M El SahlyDepartments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States. Electronic address: hanae@bcm.edu.
Evan J AndersonDepartment of Pediatrics, Emory University School of Medicine, Atlanta, GA, United States.
Lisa A JacksonKaiser Permanente Washington Health Research Institute, Seattle, WA, United States.
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, United States.
Robert L AtmarDepartments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, TX, United States.
David I BernsteinCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, United States.
Wilbur H ChenCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, United States.
C Buddy CreechVanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN, United States.
Sharon E FreyDepartment of Internal Medicine, Saint Louis University School of Medicine, St. Louis, MO, United States.
Paul GoepfertDivision of Infectious Diseases, University of Alabama at Birmingham, School of Medicine, Birmingham, AL, United States.
Jeffery MeierDepartment of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA, United States.
Varun PhadkeThe Hope Clinic, Emory University School of Medicine, Atlanta, GA, United States.
Nadine RouphaelThe Hope Clinic, Emory University School of Medicine, Atlanta, GA, United States.
Richard RuppSealy Institute for Vaccine Sciences, University of Texas Medical Branch, Galveston, TX, United States.
Jack T StapletonDepartment of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA, United States.
Paul SpearmanCincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, OH, United States.
Emmanuel B WalterDuke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, United States.
Patricia L WinokurDepartment of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA, United States.
Inci YildirimDepartment of Pediatrics, Emory University School of Medicine, Atlanta, GA, United States.
Tracie L WilliamsClinical Chemistry Branch, Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, United States.
Jennifer OshinskyCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, United States.
Lynda CoughlanCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, United States.
Haye NijhuisCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, United States.
Marcela F PasettiCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, United States.
Florian KrammerDepartment of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Daniel StadlbauerDepartment of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Raffael NachbagauerDepartment of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Rachel TsongThe Emmes Company, LLC, Rockville, MD, United States.
Ashley WegelThe Emmes Company, LLC, Rockville, MD, United States.
Paul C RobertsDivision of Microbiology and Infectious Diseases, National Institutes of Health, Rockville, MD, United States.

Funding

Statistical Data Coordinating Center: Monkeypox Clinical Research Support75N93021C00012 · NIAID · THE EMMES COMPANY, LLC · PI EWELL, MARIAN · 2021 to 2025
$150.3M
NIAID Centers of Excellence for Influenza Research and Response: Universal Influenza Vaccine Research Activities75N93021C00014 · NIAID · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI GARCIA-SASTRE, ADOLFO · 2021 to 2025
$62.6M
COLLABORATIVE INFLUENZA VACCINE INNOVATION CENTERS: CLINICAL CORE75N93019C00055 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI FRANKENFIELD, JILL · 2019 to 2025
$33.8M
Patient Safety Monitoring in International Laboratories (SMILE)75N93020C00001 · NIAID · JOHNS HOPKINS UNIVERSITY · PI SOKOLL, LORI · 2020 to 2025
$18.8M
University of Iowa Institute for Clinical and Translational ScienceUM1TR004403 · NCATS · UNIVERSITY OF IOWA · PI Marlan R Hansen, Patricia Winokur · 2023 to 2026
$16.1M
Combining innovative molecular adjuvanting approaches with novel adenoviral vector delivery to generate a universal influenza vaccineR01AI148369 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI COUGHLAN, LYNDA · 2022 to 2025
$2.0M
BLRD VA I01 BX000207HHS HHSN272201800003IHHS HHSO1002012000131IHHS HHSO100201600004IHHS HHSO100201600006INCATS NIH HHS UM1 TR004403NIAID NIH HHS 75N93019C00055NIAID NIH HHS 75N93020C00001NIAID NIH HHS 75N93021C00012NIAID NIH HHS 75N93021C00014NIAID NIH HHS HHSN272201000017CNIAID NIH HHS HHSN2722013000017INIAID NIH HHS HHSN272201300007CNIAID NIH HHS HHSN272201300015CNIAID NIH HHS HHSN272201300015INIAID NIH HHS HHSN272201300016CNIAID NIH HHS HHSN272201300016INIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201300018CNIAID NIH HHS HHSN272201300018INIAID NIH HHS HHSN272201300019CNIAID NIH HHS HHSN272201300019INIAID NIH HHS HHSN272201300020INIAID NIH HHS HHSN272201300021INIAID NIH HHS HHSN272201300022CNIAID NIH HHS HHSN272201300022INIAID NIH HHS HHSN272201300023CNIAID NIH HHS HHSN272201300023INIAID NIH HHS HHSN27220130021INIAID NIH HHS R01 AI148369
6 · The paper itself

Abstract

introductionPandemic influenza vaccine development focuses on the hemagglutinin (HA) antigen for potency and immunogenicity. Antibody responses targeting the neuraminidase (NA) antigen, or the HA stalk domain have been implicated in protection against influenza. Responses to the NA and HA-stalk domain following pandemic inactivated influenza are not well characterized in humans. MATERIAL AND

methodsIn a series of clinical trials, we determine the vaccines' NA content and demonstrate that NA inhibition (NAI) antibody responses increase in a dose-dependent manner following a 2-dose priming series with AS03-adjuvanted influenza A(H7N9) inactivated vaccine (A(H7N9) IIV). NAI antibody responses also increase with interval extension of the 2-dose priming series or following a 5-year delayed boost with a heterologous adjuvanted A(H7N9) IIV. Neither concomitant seasonal influenza vaccination given simultaneously or sequentially, nor use of heterologous A(H7N9) IIVs in the 2-dose priming series had an appreciable effect on NAI antibody responses. Anti-HA stalk antibody responses were minimal and not durable.

conclusionsWe provide evidence for strategies to improve anti-neuraminidase responses which can be further standardized for pandemic preparedness. CLINICAL TRIAL REGISTRY NUMBERS: NCT03312231, NCT03318315, NCT03589807, NCT03738241.

Indexed as

Antibodies, ViralHemagglutinin Glycoproteins, Influenza VirusInfluenza A Virus, H7N9 SubtypeInfluenza, HumanInfluenza VaccinesNeuraminidaseAdjuvants, ImmunologicAdjuvants, VaccineAdolescentAdultFemaleHumansMaleMiddle AgedPolysorbatesVaccines, InactivatedAdjuvants, ImmunologicAdjuvants, VaccineAntibodies, ViralHemagglutinin Glycoproteins, Influenza VirusInfluenza VaccinesNeuraminidasePolysorbatesVaccines, Inactivated

Identifiers

PMID39756216
PMCPMC12697238

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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.