Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified

Kim Hanna, Maria Cristina Cruz, Elsa Mondou, Edward Corsi, Peter Vandeberg Grifols Bioscience Research Group, Grifols Inc, Research Triangle Park, NC, USA Background: Rabies immune globulin (RIG) and vaccination series are necessary for postexposure prophylaxis. A new formulation of RIG (human) puri...

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Autores principales:	Hanna K, Cruz MC, Mondou E, Corsi E, Vandeberg P
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	rabies rabies immune globulin RIG-C prophylaxis rabies neutralizing antibody titers GTI1301 Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/7afab29b7332425690ce7b82dad60325
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spelling	oai:doaj.org-article:7afab29b7332425690ce7b82dad603252021-12-02T01:54:29ZSafety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified1179-1438https://doaj.org/article/7afab29b7332425690ce7b82dad603252018-06-01T00:00:00Zhttps://www.dovepress.com/safety-and-neutralizing-rabies-antibody-in-healthy-subjects-given-a-si-peer-reviewed-article-CPAAhttps://doaj.org/toc/1179-1438Kim Hanna, Maria Cristina Cruz, Elsa Mondou, Edward Corsi, Peter Vandeberg Grifols Bioscience Research Group, Grifols Inc, Research Triangle Park, NC, USA Background: Rabies immune globulin (RIG) and vaccination series are necessary for postexposure prophylaxis. A new formulation of RIG (human) purified by caprylate/chromatography (RIG-C) was evaluated. Trial registration: ClinicalTrials.gov identifier: NCT02139657.Materials and methods: This open-label, single-arm study in healthy subjects evaluated neutralizing rabies antibody concentrations produced from a single 20 IU/kg intramuscular (IM) dose of RIG-C as measured by rapid fluorescent focus inhibition test (50% neutralization endpoint) 1-hour postdose and on days 1, 2, 4, 6, 8, 10, 14, 18, and 21.Results: Twelve subjects were enrolled into the study. No discontinuations, serious adverse events (AEs), or treatment-emergent clinically significant changes in laboratory parameters were observed. All AEs resolved and were mild except 1 moderate AE of oropharyngeal pain. Injection site pain (4 subjects) was most commonly reported. RIG-C produced a rapid increase in neutralizing rabies antibody: mean value 0.113 IU/mL at 24 hours after IM injection, peak on day 4 (0.132 IU/mL), persisting through day 21 (0.116 IU/mL). The mean reciprocal titer was 11.5 by day 2; the peak value of 12.1 was achieved on day 4; and a mean value ≥10.6 was maintained through day 21.Conclusion: RIG-C was well tolerated and provided neutralizing rabies antibodies, which combined with vaccine series after rabies exposure, should result in effective prophylaxis per World Health Organization/Centers for Disease Control and Prevention guidelines. Keywords: rabies, rabies immune globulin, RIG-C, prophylaxis, rabies neutralizing antibody titers, GTI1301Hanna KCruz MCMondou ECorsi EVandeberg PDove Medical Pressarticlerabiesrabies immune globulinRIG-Cprophylaxisrabies neutralizing antibody titersGTI1301Therapeutics. PharmacologyRM1-950ENClinical Pharmacology: Advances and Applications, Vol Volume 10, Pp 79-88 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	rabies rabies immune globulin RIG-C prophylaxis rabies neutralizing antibody titers GTI1301 Therapeutics. Pharmacology RM1-950
spellingShingle	rabies rabies immune globulin RIG-C prophylaxis rabies neutralizing antibody titers GTI1301 Therapeutics. Pharmacology RM1-950 Hanna K Cruz MC Mondou E Corsi E Vandeberg P Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified
description	Kim Hanna, Maria Cristina Cruz, Elsa Mondou, Edward Corsi, Peter Vandeberg Grifols Bioscience Research Group, Grifols Inc, Research Triangle Park, NC, USA Background: Rabies immune globulin (RIG) and vaccination series are necessary for postexposure prophylaxis. A new formulation of RIG (human) purified by caprylate/chromatography (RIG-C) was evaluated. Trial registration: ClinicalTrials.gov identifier: NCT02139657.Materials and methods: This open-label, single-arm study in healthy subjects evaluated neutralizing rabies antibody concentrations produced from a single 20 IU/kg intramuscular (IM) dose of RIG-C as measured by rapid fluorescent focus inhibition test (50% neutralization endpoint) 1-hour postdose and on days 1, 2, 4, 6, 8, 10, 14, 18, and 21.Results: Twelve subjects were enrolled into the study. No discontinuations, serious adverse events (AEs), or treatment-emergent clinically significant changes in laboratory parameters were observed. All AEs resolved and were mild except 1 moderate AE of oropharyngeal pain. Injection site pain (4 subjects) was most commonly reported. RIG-C produced a rapid increase in neutralizing rabies antibody: mean value 0.113 IU/mL at 24 hours after IM injection, peak on day 4 (0.132 IU/mL), persisting through day 21 (0.116 IU/mL). The mean reciprocal titer was 11.5 by day 2; the peak value of 12.1 was achieved on day 4; and a mean value ≥10.6 was maintained through day 21.Conclusion: RIG-C was well tolerated and provided neutralizing rabies antibodies, which combined with vaccine series after rabies exposure, should result in effective prophylaxis per World Health Organization/Centers for Disease Control and Prevention guidelines. Keywords: rabies, rabies immune globulin, RIG-C, prophylaxis, rabies neutralizing antibody titers, GTI1301
format	article
author	Hanna K Cruz MC Mondou E Corsi E Vandeberg P
author_facet	Hanna K Cruz MC Mondou E Corsi E Vandeberg P
author_sort	Hanna K
title	Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified
title_short	Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified
title_full	Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified
title_fullStr	Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified
title_full_unstemmed	Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified
title_sort	safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/7afab29b7332425690ce7b82dad60325
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Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified

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