Article ; Online: A Multicenter, Controlled Human Infection Study of Influenza A(H1N1)pdm09 in Healthy Adults.
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. |
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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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Database | MEDical Literature Analysis and Retrieval System OnLINE |
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