Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2015
Validation of the wild-type influenza A human challenge model H1N1pdMIST: an A(H1N1)pdm09 dose-finding investigational new drug study.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2015. 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 111 papers, 2 of them syntheses that pooled 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.
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.
Influenza A 2009 H1N1 Human Challenge Study in Healthy Adult Volunteers
Phase IIb Study of the Efficacy of FLU-v, a Broad Spectrum Influenza Vaccine in an H1N1 Influenza Healthy Human Challenge Model
Dose-Escalation Study of a Low Pathogenicity Avian H10N7 Influenza Virus in a Healthy Human Challenge Model
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
Who cites it
111 citing papers in PubMed, 2 syntheses or guidelines pooled it, 168 citations in OpenAlex.
- Protection From COVID-19–The Efficacy of Face Masks.Deutsches Arzteblatt international · 2021Pooled it
- The Future of Flu: A Review of the Human Challenge Model and Systems Biology for Advancement of Influenza Vaccinology.Frontiers in cellular and infection microbiology · 2019Pooled it
- Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Landscape of coordinated immune responses to H1N1 challenge in humans.The Journal of clinical investigation · 2020Trial
- Assessing the Protective Potential of H1N1 Influenza Virus Hemagglutinin Head and Stalk Antibodies in Humans.Journal of virology · 2019Trial
- Correlates of Protection against Influenza in the Elderly: Results from an Influenza Vaccine Efficacy Trial.Clinical and vaccine immunology : CVI · 2016Trial
- Trial
- Exposure route, not dose, is the primary driver of infection patterns for a respiratory virus.Science advances · 2026Article
- The roles of pre-season immunity, age, viral shedding, and community exposures in shaping influenza household transmission dynamics.Nature communications · 2026Article
- Environmental temperature and relative humidity shape post-emission aerosol fate and airborne influenza transmission.Journal of virology · 2026Article
- Exposure route drives SARS-CoV-2 infection patterns in non-human primates.bioRxiv : the preprint server for biology · 2026Article
- Resistance Mutations to Broadly Neutralizing Antibodies Destabilize Hemagglutinin and Attenuate H1N1 Influenza Virus.Viruses · 2025Article
- Controlled human influenza infection reveals heterogeneous expulsion of infectious virus into air.medRxiv : the preprint server for health sciences · 2025Article
- Multivariate Host-Pathogen Interactions Driving Heterogeneous Viral Shedding and CD8medRxiv : the preprint server for health sciences · 2025Article
- Quantifying viral load and characterizing virus diversity in wildlife samples with target enrichment sequencing.Microbial genomics · 2025Article
- Dose-Dependent Porcine Deltacoronavirus Infection Reveals Linkage Between Infectious Dose and Immune Response.Animals : an open access journal from MDPI · 2025Article
- Nasal and systemic immune responses correlate with viral shedding after influenza challenge in people with complex preexisting immunity.Science translational medicine · 2025Article
- Pathogenesis Induced by Influenza Virus Infection: Role of the Early Events of the Infection and the Innate Immune Response.Viruses · 2025Review
- A Review of Cross-Species Transmission Mechanisms of Influenza Viruses.Veterinary sciences · 2025Review
- Article
51 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundHealthy volunteer wild-type influenza challenge models offer a unique opportunity to evaluate multiple aspects of this important virus. Such studies have not been performed in the United States in more than a decade, limiting our capability to investigate this virus and develop countermeasures. We have completed the first ever wild-type influenza A challenge study under an Investigational New Drug application (IND). This dose-finding study will lead to further development of this model both for A(H1N1)pdm09 and other strains of influenza.
methodsVolunteers were admitted to an isolation unit at the National Institutes of Health Clinical Center for a minimum of 9 days. A reverse genetics, cell-based, Good Manufacturing Practice (GMP)-produced, wild-type A(H1N1)pdm09 virus was administered intranasally. Escalating doses were given until a dose was reached that produced disease in a minimum of 60% of volunteers.
resultsAn optimal dose of 10(7) tissue culture infectious dose 50 was reached that caused mild to moderate influenza disease in 69% of individuals with mean viral shedding for 4-5 days and significant rises in convalescent influenza antibody titers. Viral shedding preceded symptoms by 12-24 hours and terminated 2-3 days prior to symptom resolution, indicating that individuals may be infectious before symptom development. As expected, nasal congestion and rhinorrhea were most common, but interestingly, fever was observed in only 10% of individuals.
conclusionsThis study represents the first healthy volunteer influenza challenge model using a GMP-produced wild-type virus under an IND. This unique clinical research program will facilitate future studies of influenza pathogenesis, animal model validation, and the rapid, efficient, and cost-effective evaluation of efficacy of novel vaccines and therapeutics. Clinical Trials Registration.NCT01646138.
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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.