Evidence map›Paper›PMID 36702771›Full record

ArticleThe Journal of infectious diseases2023

A Multicenter, Controlled Human Infection Study of Influenza A(H1N1)pdm09 in Healthy Adults.

Justin R Ortiz, David I Bernstein, Daniel F Hoft, Christopher W Woods, Micah T McClain, Sharon E Frey, Rebecca C Brady, Christopher Bryant, Ashley Wegel, Robert W Frenck and 10 more

2 registry-linked trialsOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in The Journal of infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.0field-weighted citation impact, top 8% 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.

NCT04044352 phase1completednot on this map

A Controlled Human Infection Study of Influenza A/Bethesda/MM2/H1N1 Virus (A/California/04/2009/H1N1-like) in Healthy Subjects to Assess the Effect of Pre-Existing Immunity on Symptomatic Influenza Virus Infection

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2019 to 2020Enrolled76ConditionsInfluenzaArmsInfluenza A/Bethesda/MM2/H1N1 Challenge
NCT07063849 phase1active not recruitingnot on this mapstarted 2025, after this paper: background citation

A Pilot Study of the Effects of Pre-Existing Immunity on Influenza A/Texas/71/2017 (H3N2) Virus Shedding After Human Challenge in Healthy Participants

TypeinterventionalSponsorDaniel Hoft, MD, PhDRan2025 to 2026Enrolled12ConditionsInfluenzaArmsA/Texas
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Review
  3. 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
  4. 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
  5. Vaccine Treatment and Evaluation Units: Why Support a "Ready Base" of Clinical Trial Sites?Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. 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 9 institutions in 1 country.

Justin R OrtizCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.ORCID 0000-0002-3138-5965
David I BernsteinCincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio; Departments of.ORCID 0000-0002-0100-1991
Daniel F HoftInternal Medicine and.
Christopher W WoodsDivision of Infectious Diseases, Duke University Medical Center, Durham, North Carolina.ORCID 0000-0001-7240-2453
Micah T McClainDivision of Infectious Diseases, Duke University Medical Center, Durham, North Carolina.ORCID 0000-0001-8034-1136
Sharon E FreyInternal Medicine and.
Rebecca C BradyCincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio; Departments of.ORCID 0000-0002-7635-6172
Christopher BryantVaccine and Infectious Disease Therapeutic Research Unit, The Emmes Company, Rockville, Maryland.ORCID 0000-0003-2118-6062
Ashley WegelVaccine and Infectious Disease Therapeutic Research Unit, The Emmes Company, Rockville, Maryland.ORCID 0000-0002-1643-0668
Robert W FrenckCincinnati Children's Hospital Medical Center, University of Cincinnati, Ohio; Departments of.ORCID 0000-0002-2336-526X
Emmanuel B WalterDuke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina.ORCID 0000-0001-6502-6736
Getahun AbateInternal Medicine and.ORCID 0000-0002-7825-2422
Sarah R WilliamsDivision of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, Baltimore.ORCID 0000-0002-7413-0233
Robert L AtmarSection of Infectious Diseases, Department of Medicine, Baylor College of Medicine, Houston, Texas.ORCID 0000-0001-9989-6772
Wendy A KeitelDepartments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, Texas.ORCID 0000-0003-0217-332X
Nadine RouphaelHope Clinic of the Emory Vaccine Center, Division of Infectious Diseases, Department of Medicine, School of Medicine, Emory University, Atlanta, Georgia.ORCID 0000-0002-2512-7919
Mathew J MemoliLaboratory of Infectious Diseases.ORCID 0000-0001-6393-5178
Mamodikoe K MakheneDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.
Paul C RobertsDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.ORCID 0000-0002-4452-141X
Kathleen M NeuzilCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore.ORCID 0000-0001-9480-2714
Cincinnati Children's Hospital Medical Center · USUniversity of Maryland, Baltimore · USBaylor College of Medicine · USDuke Medical Center · USEmmes (United States) · USNational Institute of Allergy and Infectious Diseases · USDuke University · USEmory University · USSaint Louis University · 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
Pandemic Influenza Translational Research; Novel Vaccine and Drug TherapyZIAAI001157 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI MEMOLI, MATTHEW · 2012 to 2025
$37.2M
A Phase I Randomized Clinical Trial of a Novel Mucosal Recombinant H5 Influenza Vaccine with Nanoemulsion Adjuvant Followed by Parenteral Boost of Licensed Inactivated Influenza A H5N1 VaccineU01AI148081 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI ORTIZ, JUSTIN R. · 2020 to 2023
$1.8M
Determine if a candidate dengue vaccine in advanced trials induces antigen-specific cellular immunity that mimics immunity after multiple infections and controls antibody-enhanced viral replicationI01BX003714 · VA · ST. LOUIS VA MEDICAL CENTER · PI GEORGE, SARAH · 2017 to 2020
–
BLRD VA I01 BX003714NCATS NIH HHS UL1 TR003098NIAID NIH HHS 75N93021C00012NIAID NIH HHS HHSN272200800003CNIAID NIH HHS HHSN272201300015INIAID NIH HHS HHSN272201300016INIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201300018INIAID NIH HHS HHSN272201300022INIAID NIH HHS U01 AI148081
6 · The paper itself

Abstract

backgroundWe evaluated the associations between baseline influenza virus-specific hemagglutination inhibition (HAI) and microneutralization (MN) titers and subsequent symptomatic influenza virus infection in a controlled human infection study.

methodsWe inoculated unvaccinated healthy adults aged 18-49 years with an influenza A/California/04/2009/H1N1pdm-like virus (NCT04044352). We collected serial safety labs, serum for HAI and MN, and nasopharyngeal swabs for reverse-transcription polymerase chain reaction (RT-PCR) testing. Analyses used the putative seroprotective titer of ≥40 for HAI and MN. The primary clinical outcome was mild-to-moderate influenza disease (MMID), defined as ≥1 postchallenge positive qualitative RT-PCR test with a qualifying symptom/clinical finding.

resultsOf 76 participants given influenza virus challenge, 54 (71.1%) experienced MMID. Clinical illness was generally very mild. MMID attack rates among participants with baseline titers ≥40 by HAI and MN were 64.9% and 67.9%, respectively, while MMID attack rates among participants with baseline titers <40 by HAI and MN were 76.9% and 78.3%, respectively. The estimated odds of developing MMID decreased by 19% (odds ratio, 0.81 [95% confidence interval, .62-1.06]; P = .126) for every 2-fold increase in baseline HAI. There were no significant adverse events.

conclusionsWe achieved a 71.1% attack rate of MMID. High baseline HAI and MN were associated with protection from illness. Clinical Trials Registration. NCT04044352.

Indexed as

Influenza A Virus, H1N1 SubtypeInfluenza, HumanInfluenza VaccinesAdultAntibodies, ViralHemagglutination Inhibition TestsHumansResearch DesignAntibodies, ViralInfluenza Vaccinesclinical trialH1N1 subtypehumaninfluenzainfluenza A virus

Identifiers

PMID36702771
PMCPMC10420403
OpenAlexW4318264032

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.