INSIGHT FLU005: An Anti-Influenza Virus Hyperimmune Intravenous Immunoglobulin Pilot Study

J Infect Dis. 2016 Feb 15;213(4):574-8. doi: 10.1093/infdis/jiv453. Epub 2015 Sep 15.

Abstract

Hemagglutination inhibition (HAI) antibody responses to anti-influenza virus hyperimmune intravenous immunoglobulin (hIVIG) were characterized. Thirty-one patients with influenza during the 2013-2014 season were randomly assigned to receive 0.25 g/kg of hIVIG (n = 16) or placebo (n = 15). For hIVIG recipients, the ratio of geometric mean titers (1 hour after infusion/before infusion) was 4.00 (95% confidence interval [CI], 2.61-6.13) for 2009 pandemic influenza A(H1N1) and 1.76 (95% CI, 1.33-2.32) for influenza A(H3N2) and influenza B. Among patients with 2009 pandemic influenza A(H1N1), ratios for hIVIG (n = 9) versus placebo (n = 8) were higher 1 hour after infusion (3.9 [95% CI, 2.3-6.7]) and sustained through day 3 (2.0 [95% CI, 1.0-4.0]). hIVIG administration significantly increases HAI titer levels among patients with influenza, supporting the need to perform a clinical outcomes study.

Clinical trials registration: NCT02008578.

Keywords: antibody titers; anti–influenza virus hIVIG; influenza; randomized trial.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Intramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Viral / blood
  • Double-Blind Method
  • Female
  • Hemagglutination Inhibition Tests
  • Humans
  • Immunization, Passive / methods*
  • Immunoglobulins, Intravenous / therapeutic use*
  • Influenza A Virus, H1N1 Subtype / immunology
  • Influenza A Virus, H3N2 Subtype / immunology
  • Influenza B virus / immunology
  • Influenza, Human / therapy*
  • Male
  • Middle Aged
  • Pilot Projects
  • Placebos / administration & dosage
  • Treatment Outcome
  • Young Adult

Substances

  • Antibodies, Viral
  • Immunoglobulins, Intravenous
  • Placebos

Associated data

  • ClinicalTrials.gov/NCT02008578