INSIGHT FLU005: An Anti-Influenza Virus Hyperimmune Intravenous Immunoglobulin Pilot Study
INSIGHT FLU005 IVIG Pilot Study Group, Richard T Davey Jr, Norman Markowitz, John Beigel, Deborah Wentworth, Abdel Babiker, Tauseef Rehman, Robin Dewar, Julia Metcalf, Timothy M Uyeki, Elizabeth B Finley, Barbara Standridge, Paul Riska, H Clifford Lane, Fred Gordin, James D Neaton, E Denning, A DuChene, N Engen, M Harrison, K Quan, G Thompson, Adriana Sanchez, Marie Hoover, Venn Natarajan, H Preston Holley, John Tierney, Jocelyn Voell, J Baxter, D Bigley, P Coburn, L Faber, E Gardner, L Harlow, M Jain, L Makohon, R McConnell, J Moghe, R Nahra, B Omotosho, T Petersen, H Polenakovik, S Rizza, J Scott, A Shoen, C Solorzano, Z Temesgen, J Whittaker, INSIGHT FLU005 IVIG Pilot Study Group, Richard T Davey Jr, Norman Markowitz, John Beigel, Deborah Wentworth, Abdel Babiker, Tauseef Rehman, Robin Dewar, Julia Metcalf, Timothy M Uyeki, Elizabeth B Finley, Barbara Standridge, Paul Riska, H Clifford Lane, Fred Gordin, James D Neaton, E Denning, A DuChene, N Engen, M Harrison, K Quan, G Thompson, Adriana Sanchez, Marie Hoover, Venn Natarajan, H Preston Holley, John Tierney, Jocelyn Voell, J Baxter, D Bigley, P Coburn, L Faber, E Gardner, L Harlow, M Jain, L Makohon, R McConnell, J Moghe, R Nahra, B Omotosho, T Petersen, H Polenakovik, S Rizza, J Scott, A Shoen, C Solorzano, Z Temesgen, J Whittaker
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.
© The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.
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Source: PubMed