Evidence map›Paper›PMID 39798434›Full record

Trial reportVaccine2025

Safety and immunogenicity of ascending doses of influenza A(H7N9) inactivated vaccine with or without MF59®.

Sharon E Frey, Rebecca Brady, Lisa Jackson, Paul Goepfert, Hana M El Sahly, Robert L Atmar, Richard Rupp, C Buddy Creech, Getahun Abate, Grant Paulsen and 3 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
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. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

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

3 citing papers in PubMed.

  1. Article
  2. 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
  3. 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

13 authors.

Sharon E FreySaint Louis University Center for Vaccine Development, Department of Internal Medicine, Saint Louis University School of Medicine, St. Louis, MO, USA.
Rebecca BradyCincinnati Children's Hospital Medical Center, Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Lisa JacksonKaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.
Paul GoepfertDivision of Infectious Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Hana M El SahlyDepartments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, TX, USA.
Robert L AtmarDepartments of Molecular Virology and Microbiology and Medicine, Baylor College of Medicine, Houston, TX, USA.
Richard RuppSealy Institute for Vaccine Science, The University of Texas Medical Branch, Galveston, TX, USA.
C Buddy CreechVanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.
Getahun AbateSaint Louis University Center for Vaccine Development, Department of Internal Medicine, Saint Louis University School of Medicine, St. Louis, MO, USA.
Grant PaulsenCincinnati Children's Hospital Medical Center, Division of Infectious Diseases, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Julia WeissThe Emmes Company, LLC, Rockville, MD, USA.
Ashley WegelThe Emmes Company, LLC, Rockville, MD, USA.
Paul C RobertsDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.

Funding

Statistical Data Coordinating Center: Monkeypox Clinical Research Support75N93021C00012 · NIAID · THE EMMES COMPANY, LLC · PI EWELL, MARIAN · 2021 to 2025
$150.3M
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
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
HHS HHSN27200015HHS HHSN27220139921INCATS NIH HHS UL1 TR002243NIAID NIH HHS 75N93021C00012NIAID NIH HHS HHSN272201300015CNIAID NIH HHS HHSN272201300015INIAID NIH HHS HHSN272201300016CNIAID NIH HHS HHSN272201300016INIAID NIH HHS HHSN272201300019CNIAID NIH HHS HHSN272201300019INIAID NIH HHS HHSN272201300021INIAID NIH HHS HHSN272201300023CNIAID NIH HHS HHSN272201300023INIAID NIH HHS UM1 AI148685
6 · The paper itself

Abstract

introductionWhile it remains impossible to predict the timing of the next influenza pandemic, novel avian influenza A viruses continue to be considered a significant threat.

methodsA Phase II study was conducted in healthy adults aged 18-64 years to assess the safety and immunogenicity of two intramuscular doses of pre-pandemic 2017 influenza A(H7N9) inactivated vaccine administered 21 days apart. Participants were randomized (n = 105 in each of Arms 1-3) to receive 3.75 μg, 7.5 μg or 15 μg of hemagglutinin (HA) with MF59® adjuvant, or 15 μg of HA unadjuvanted vaccine (n = 57, Arm 4).

resultsThe three MF59 adjuvanted vaccines and the 15 μg unadjuvanted vaccine were safe and well-tolerated. Little antibody activity was detected against the A(H7N9) vaccine antigen after the first vaccination across study Arms. After second vaccination, the three adjuvanted Arms showed increases in hemagglutination inhibition (HAI), neutralizing (Neut), and neuraminidase inhibition (NAI) geometric mean titers (GMT), peaking at 21 days post second vaccination. The percentage of participants with titer ≥1:40 and seroconversion rates for HAI were 30-43 % and 0 for the adjuvanted Arms and the unadjuvanted Arm, respectively. Antibody responses against antigenically drifted A(H7N9) strains A/Shanghai/2/2013 and A/Guangdong/17SF003/2016 showed similar trends. Exploratory linear modeling of HAI and Neut responses post second vaccination revealed significantly lower log antibody titers among older participants (aged 35-49 and 50-64 years) compared to participants aged 18-34 years after adjusting for study vaccination, BMI, sex, and prior seasonal influenza vaccination. Post second vaccination, participants who received seasonal influenza vaccination in at least one of the two previous seasons had significantly lower log antibody titers than participants who did not.

conclusionAdjuvanted doses of vaccine provided higher antibody responses, on average, than the 15 μg unadjuvanted vaccine. Proportion of participants achieving seroconversion and antibody titers ≥40 remained below 50 % in all study Arm.

Indexed as

Adjuvants, ImmunologicImmunogenicity, VaccineInfluenza A Virus, H7N9 SubtypeInfluenza, HumanInfluenza VaccinesPolysorbatesSqualeneAdjuvants, VaccineAdolescentAdultAntibodies, NeutralizingAntibodies, ViralFemaleHemagglutination Inhibition TestsHumansInjections, IntramuscularAdjuvants, ImmunologicAdjuvants, VaccineAntibodies, NeutralizingAntibodies, ViralInfluenza VaccinesMF59 oil emulsionPolysorbatesSqualeneVaccines, InactivatedAdultA(H7N9)Dose-escalationMF59Pandemic influenzaPhase 2

Identifiers

PMID39798434
PMCPMC12096342

What OpenQuestion holds

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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.