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- Title
A Multicenter, Controlled Human Infection Study of Influenza A(H1N1)pdm09 in Healthy Adults.
- Authors
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
- 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.
- Subjects
CALIFORNIA; H7N9 Influenza; INFLUENZA; CLINICAL trial registries; VIRUS diseases; HUMAN experimentation; INFECTION control
- Publication
Journal of Infectious Diseases, 2023, Vol 228, Issue 3, p287
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jiad021