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

Ortiz, Justin R / Bernstein, David I / Hoft, Daniel F / Woods, Christopher W / McClain, Micah T / Frey, Sharon E / Brady, Rebecca C / Bryant, Christopher / Wegel, Ashley / Frenck, Robert W / Walter, Emmanuel B / Abate, Getahun / Williams, Sarah R / Atmar, Robert L / Keitel, Wendy A / Rouphael, Nadine / Memoli, Mathew J / Makhene, Mamodikoe K / Roberts, Paul C /
Neuzil, Kathleen M

The Journal of infectious diseases

2023  Volume 228, Issue 3, Page(s) 287–298

Abstract: Background: We 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.: ... ...

Abstract Background: We 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.
Methods: We 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.
Results: Of 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.
Conclusions: We achieved a 71.1% attack rate of MMID. High baseline HAI and MN were associated with protection from illness. Clinical Trials Registration. NCT04044352.
MeSH term(s) Humans ; Adult ; Influenza, Human/prevention & control ; Influenza A Virus, H1N1 Subtype ; Antibodies, Viral ; Research Design ; Hemagglutination Inhibition Tests ; Influenza Vaccines
Chemical Substances Antibodies, Viral ; Influenza Vaccines
Language English
Publishing date 2023-01-31
Publishing country United States
Document type Multicenter Study ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID 3019-3
ISSN 1537-6613 ; 0022-1899
ISSN (online) 1537-6613
ISSN 0022-1899
DOI 10.1093/infdis/jiad021
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