INSIGHT FLU005: An Anti-Influenza Virus Hyperimmune Intravenous Immunoglobulin Pilot Study
Recommended Citation
Davey R.T., Markowitz N., Beigel J., Wentworth D., Babiker A., Rehman T., Dewar R., Metcalf J., Uyeki T.M., Finley E.B., Standridge B., Riska P., Lane H.C., Gordin F., Neaton J.D., Denning E., Duchene A., Engen N., Harrison M., Quan K., Thompson G., Sanchez A., Hoover M., Natarajan V., Holley H.P., Tierney J., Voell J., Baxter J., Bigley D., Coburn P., Faber L., Gardner E., Harlow L., Jain M., Makohon L., Mcconnell R., Moghe J., Nahra R., Omotosho B., Petersen T., Polenakovik H., Rizza S., Scott J., Shoen A., Solorzano C., Temesgen Z., Whittaker J., and INSIGHT FLU005 IVIG Pilot Study Group. INSIGHT FLU005: An Anti-Influenza Virus Hyperimmune Intravenous Immunoglobulin Pilot Study. J Infect Dis 2016; 213(4):574-578.
Document Type
Article
Publication Date
2-15-2016
Publication Title
J Infect Dis
Abstract
UNLABELLED: 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.
Medical Subject Headings
Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Viral; Double-Blind Method; Female; Hemagglutination Inhibition Tests; Humans; Immunization, Passive; Immunoglobulins, Intravenous; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H3N2 Subtype; Influenza B virus; Influenza, Human; Male; Middle Aged; Pilot Projects; Placebos; Treatment Outcome; Young Adult
PubMed ID
26374911
Volume
213
Issue
4
First Page
574
Last Page
578
