INSIGHT FLU005: An anti-influenza virus hyperimmune intravenous immunoglobulin pilot study

Richard T. Davey; 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. Whitaker

doi:10.1093/infdis/jiv453

INSIGHT FLU005: An anti-influenza virus hyperimmune intravenous immunoglobulin pilot study

Richard T. Davey, 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. QuanG. 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. Whitaker

Medicine

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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.

Original language	English (US)
Pages (from-to)	574-578
Number of pages	5
Journal	Journal of Infectious Diseases
Volume	213
Issue number	4
DOIs	https://doi.org/10.1093/infdis/jiv453
State	Published - Feb 15 2016

Keywords

anti-influenza virus hIVIG
antibody titers
influenza
randomized trial

ASJC Scopus subject areas

Medicine(all)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1093/infdis/jiv453

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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., ... Whitaker, J. (2016). INSIGHT FLU005: An anti-influenza virus hyperimmune intravenous immunoglobulin pilot study. Journal of Infectious Diseases, 213(4), 574-578. https://doi.org/10.1093/infdis/jiv453

Davey, RT, Markowitz, N, Beigel, J, Wentworth, D, Babiker, A, Rehman, T, Dewar, R, Metcalf, J, Uyeki, TM, Finley, EB, Standridge, B, Riska, P, Lane, HC, Gordin, F, Neaton, JD, Denning, E, Duchene, A, Engen, N, Harrison, M, Quan, K, Thompson, G, Sanchez, A, Hoover, M, Natarajan, V, Holley, HP, 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 & Whitaker, J 2016, 'INSIGHT FLU005: An anti-influenza virus hyperimmune intravenous immunoglobulin pilot study', Journal of Infectious Diseases, vol. 213, no. 4, pp. 574-578. https://doi.org/10.1093/infdis/jiv453

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title = "INSIGHT FLU005: An anti-influenza virus hyperimmune intravenous immunoglobulin pilot study",

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 = "anti-influenza virus hIVIG, antibody titers, influenza, randomized trial",

author = "Davey, {Richard T.} and Norman Markowitz and John Beigel and Deborah Wentworth and Abdel Babiker and Tauseef Rehman and Robin Dewar and Julia Metcalf and Uyeki, {Timothy M.} and Finley, {Elizabeth B.} and Barbara Standridge and Paul Riska and Lane, {H. Clifford} and Fred Gordin and Neaton, {James D.} and E. Denning and A. Duchene and N. Engen and M. Harrison and K. Quan and G. Thompson and Adriana Sanchez and Marie Hoover and Venn Natarajan and Holley, {H. Preston} and John Tierney and Jocelyn Voell and J. Baxter and D. Bigley and P. Coburn and L. Faber and E. Gardner and L. Harlow and M. Jain and L. Makohon and R. Mcconnell and J. Moghe and R. Nahra and B. Omotosho and T. Petersen and H. Polenakovik and S. Rizza and J. Scott and A. Shoen and C. Solorzano and Z. Temesgen and J. Whitaker",

note = "Funding Information: We thank the patients who participated in the study. This work was supported by the NIAID Intramural Research Program and the NIAID Division of Clinical Research, through a contract with the University of Minnesota (Leidos prime contract HHSN261200800001E). Publisher Copyright: {\textcopyright} The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America.",

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doi = "10.1093/infdis/jiv453",

language = "English (US)",

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T2 - An anti-influenza virus hyperimmune intravenous immunoglobulin pilot study

AU - Davey, Richard T.

AU - Markowitz, Norman

AU - Beigel, John

AU - Wentworth, Deborah

AU - Babiker, Abdel

AU - Rehman, Tauseef

AU - Dewar, Robin

AU - Metcalf, Julia

AU - Uyeki, Timothy M.

AU - Finley, Elizabeth B.

AU - Standridge, Barbara

AU - Riska, Paul

AU - Lane, H. Clifford

AU - Gordin, Fred

AU - Neaton, James D.

AU - Denning, E.

AU - Duchene, A.

AU - Engen, N.

AU - Harrison, M.

AU - Quan, K.

AU - Thompson, G.

AU - Sanchez, Adriana

AU - Hoover, Marie

AU - Natarajan, Venn

AU - Holley, H. Preston

AU - Tierney, John

AU - Voell, Jocelyn

AU - Baxter, J.

AU - Bigley, D.

AU - Coburn, P.

AU - Faber, L.

AU - Gardner, E.

AU - Harlow, L.

AU - Jain, M.

AU - Makohon, L.

AU - Mcconnell, R.

AU - Moghe, J.

AU - Nahra, R.

AU - Omotosho, B.

AU - Petersen, T.

AU - Polenakovik, H.

AU - Rizza, S.

AU - Scott, J.

AU - Shoen, A.

AU - Solorzano, C.

AU - Temesgen, Z.

AU - Whitaker, J.

N1 - Funding Information: We thank the patients who participated in the study. This work was supported by the NIAID Intramural Research Program and the NIAID Division of Clinical Research, through a contract with the University of Minnesota (Leidos prime contract HHSN261200800001E). Publisher Copyright: © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America.

PY - 2016/2/15

Y1 - 2016/2/15

N2 - 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.

AB - 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.

KW - anti-influenza virus hIVIG

KW - antibody titers

KW - influenza

KW - randomized trial

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ER -

INSIGHT FLU005: An anti-influenza virus hyperimmune intravenous immunoglobulin pilot study

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Keywords

ASJC Scopus subject areas

UN SDGs

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