ArticleThe Journal of infectious diseases2013
Safety and immunological outcomes following human inoculation with nontypeable Haemophilus influenzae.
Article in The Journal of infectious diseases, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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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.
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Who cites it
10 citing papers in PubMed.
- BPZE1 vaccination induces IL-17NPJ vaccines · 2026Article
- Nasopharyngeal Swabs vs. Nasal Aspirates for Respiratory Virus Detection: A Systematic Review.Pathogens (Basel, Switzerland) · 2021Review
- Nasal Delivery of a CommensalInfection and immunity · 2020Article
- Panel 4: Recent advances in understanding the natural history of the otitis media microbiome and its response to environmental pressures.International journal of pediatric otorhinolaryngology · 2020Review
- Panel 8: Vaccines and immunology.International journal of pediatric otorhinolaryngology · 2020Review
- Development of flow cytometric opsonophagocytosis and antibody-mediated complement deposition assays for non-typeable Haemophilus influenzae.BMC microbiology · 2018Article
- The HMW1 and HMW2 Adhesins Enhance the Ability of Nontypeable Haemophilus influenzae To Colonize the Upper Respiratory Tract of Rhesus Macaques.Infection and immunity · 2016Article
- Why we need a vaccine for non-typeable Haemophilus influenzae.Human vaccines & immunotherapeutics · 2016Article
- The Lung Immune Response to Nontypeable Haemophilus influenzae (Lung Immunity to NTHi).Journal of immunology research · 2015Review
- A new human colonization model for nontypeable Haemophilus influenzae.The Journal of infectious diseases · 2013Article
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5 authors.
Funding
Abstract
backgroundNontypeable Haemophilus influenzae (NTHi) exclusively infects humans, causing significant numbers of upper respiratory tract infections. The goal of this study was to develop a safe experimental human model of NTHi nasopharyngeal colonization.
methodsA novel streptomycin-resistant strain of NTHi was developed, and 15 subjects were inoculated in an adaptive-design phase I trial to rapidly identify colonizing doses of NTHi. Bayesian analysis was used to estimate the human colonizing dose 50 and 90 (HCD50 and HCD90, respectively). Side effects and immunological responses to whole-cell sialylated NTHi were measured.
resultsNine subjects were colonized and tolerated colonization well. Immunological analyses demonstrated that 7 colonized subjects and 0 noncolonized subjects had a 4-fold rise in serum levels of immunoglobulin A, immunoglobulin M, or immunoglobulin G. Preexisting immunity to whole-cell NTHi did not predict success or failure of colonization.
conclusionsThe statistical design incorporated a slow escalation to higher dose levels. HCD50 and HCD90 Bayesian estimates were identified as approximately 2000 and 150 000 colony-forming units, respectively; credible interval estimates were broad. This study provides a potential platform for early proof of concept studies for NTHi vaccines, as well as a way to evaluate bacterial factors associated with colonization.
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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.