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

Publication ,  Journal Article
Ortiz, JR; Bernstein, DI; Hoft, DF; Woods, CW; McClain, MT; Frey, SE; Brady, RC; Bryant, C; Wegel, A; Frenck, RW; Walter, EB; Abate, G ...
Published in: J Infect Dis
August 11, 2023

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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Published In

J Infect Dis

DOI

EISSN

1537-6613

Publication Date

August 11, 2023

Volume

228

Issue

3

Start / End Page

287 / 298

Location

United States

Related Subject Headings

  • Research Design
  • Microbiology
  • Influenza, Human
  • Influenza Vaccines
  • Influenza A Virus, H1N1 Subtype
  • Humans
  • Hemagglutination Inhibition Tests
  • Antibodies, Viral
  • Adult
  • 42 Health sciences
 

Citation

APA
Chicago
ICMJE
MLA
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Ortiz, J. R., Bernstein, D. I., Hoft, D. F., Woods, C. W., McClain, M. T., Frey, S. E., … Neuzil, K. M. (2023). A Multicenter, Controlled Human Infection Study of Influenza A(H1N1)pdm09 in Healthy Adults. J Infect Dis, 228(3), 287–298. https://doi.org/10.1093/infdis/jiad021
Ortiz, Justin R., David I. Bernstein, Daniel F. Hoft, Christopher W. Woods, Micah T. McClain, Sharon E. Frey, Rebecca C. Brady, et al. “A Multicenter, Controlled Human Infection Study of Influenza A(H1N1)pdm09 in Healthy Adults.J Infect Dis 228, no. 3 (August 11, 2023): 287–98. https://doi.org/10.1093/infdis/jiad021.
Ortiz JR, Bernstein DI, Hoft DF, Woods CW, McClain MT, Frey SE, et al. A Multicenter, Controlled Human Infection Study of Influenza A(H1N1)pdm09 in Healthy Adults. J Infect Dis. 2023 Aug 11;228(3):287–98.
Ortiz, Justin R., et al. “A Multicenter, Controlled Human Infection Study of Influenza A(H1N1)pdm09 in Healthy Adults.J Infect Dis, vol. 228, no. 3, Aug. 2023, pp. 287–98. Pubmed, doi:10.1093/infdis/jiad021.
Ortiz JR, Bernstein DI, Hoft DF, Woods CW, McClain MT, Frey SE, Brady RC, Bryant C, Wegel A, Frenck RW, Walter EB, Abate G, Williams SR, Atmar RL, Keitel WA, Rouphael N, Memoli MJ, Makhene MK, Roberts PC, Neuzil KM. A Multicenter, Controlled Human Infection Study of Influenza A(H1N1)pdm09 in Healthy Adults. J Infect Dis. 2023 Aug 11;228(3):287–298.
Journal cover image

Published In

J Infect Dis

DOI

EISSN

1537-6613

Publication Date

August 11, 2023

Volume

228

Issue

3

Start / End Page

287 / 298

Location

United States

Related Subject Headings

  • Research Design
  • Microbiology
  • Influenza, Human
  • Influenza Vaccines
  • Influenza A Virus, H1N1 Subtype
  • Humans
  • Hemagglutination Inhibition Tests
  • Antibodies, Viral
  • Adult
  • 42 Health sciences