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BALB\u002Fc neonates were vaccinated with BCG on the first day after birth, sensitized with ovalbumin, and then challenged with allergen. The resulting airway inflammation and responsiveness were measured. The levels of IL-17 and interferon (IFN)-γ in BALF and ratio of Th17\u002FTh1 were investigated. We found that although BCG neonatal vaccination inhibited airway hyperresponsiveness and inflammation following allergen challenge in a BALB\u002Fc mouse asthma model, reduced levels of Th2 cytokines were not observed. However, BCG neonatal vaccination reduced IL-17 production and increased IFN-γ production in both the bronchoalveolar lavage fluid and the lung lymphocytes in asthmatic mice. The antiasthma effects of neonatal BCG vaccination reversed the IL-17\u002FIFN-γ imbalance in a murine asthma model but did not depend on modifying the Th17\u002FTh1 balance.",{"EN":221,"VI":222},"The Antiasthma Effect of Neonatal BCG Vaccination Does Not Depend on the Th17\u002FTh1 but IL-17\u002FIFN-γ Balance in a BALB\u002Fc Mouse Asthma Model","Tác dụng chống hen của tiêm chủng BCG sơ sinh không phụ thuộc vào cân bằng Th17\u002FTh1 mà phụ thuộc vào cân bằng IL-17\u002FIFN-γ trong mô hình hen ở chuột nhắt BALB\u002Fc",{"VOID":224},"Strachan DP, Butland BK, Anderson HR. Incidence and prognosis of asthma and wheezing illness from early childhood to age 33 in a national British cohort. BMJ. 1996;312:1195–9.\nErb KJ, Holloway JW, Sobeck A, Moll H, Le Gros G. Infection of mice with Mycobacterium bovis-bacillus Calmette-Guerin (BCG) suppresses allergen-induced airway eosinophilia. J Exp Med. 1998;187:561–9.\nHerz U, Gerhold K, Gruber C, Braun A, Wahn U, Renz H, et al. BCG infection suppresses allergic sensitization and development of increased airway reactivity in an animal model. J Allergy Clin Immunol. 1998;102:867–74.\nNahori MA, Lagranderie M, Lefort J, Thouron F, Joseph D, Winter N, et al. Effects of Mycobacterium bovis BCG on the development of allergic inflammation and bronchial hyperresponsiveness in hyper-IgE BP2 mice vaccinated as newborns. Vaccine. 2001;19:1484–95.\nKoh YI, Choi IS, Kim WY. BCG infection in allergen-presensitized rats suppresses Th2 immune response and prevents the development of allergic asthmatic reaction. J Clin Immunol. 2001;21:51–9.\nOliveira FH, Sarinho SW, Montenegro S, Neuenschwander C, Queiroz R, Medeiros D, et al. Production of interferon gamma in asthmatic patients with small bacille Calmette-Guerin scars: a pilot study. Allergy Asthma Proc. 2006;27:516–22.\nVargas MH, Bernal-Alcantara DA, Vaca MA, Franco-Marina F, Lascurain R. Effect of BCG vaccination in asthmatic schoolchildren. Pediatr Allergy Immunol. 2004;15:415–20.\nHubeau C, Singer M, Lagranderie M, Marchal G, Vargaftig B. Extended freeze-dried Mycobacterium bovis Bacillus Calmette-Guerin induces the release of interleukin-12 but not tumour necrosis factor-alpha by alveolar macrophages, both in vitro and in vivo. Clin Exp Allergy. 2003;33:386–93.\nLagranderie M, Nahori MA, Balazuc AM, Kiefer-Biasizzo H, Lapa e Silva JR, Milon G, et al. Dendritic cells recruited to the lung shortly after intranasal delivery of Mycobacterium bovis BCG drive the primary immune response towards a type 1 cytokine production. Immunology. 2003;108:352–64.\nda Cunha SS, Cruz AA, Dourado I, Barreto ML, Ferreira LD, Rodrigues LC. Lower prevalence of reported asthma in adolescents with symptoms of rhinitis that received neonatal BCG. Allergy. 2004;59:857–62.\nLi L, Xia Y, Nguyen A, Feng L, Lo D. Th2-induced eotaxin expression and eosinophilia coexist with Th1 responses at the effector stage of lung inflammation. J Immunol. 1998;161:3128–35.\nJeon SG, Oh SY, Park HK, Kim YS, Shim EJ, Lee HS, et al. TH2 and TH1 lung inflammation induced by airway allergen sensitization with low and high doses of double-stranded RNA. J Allergy Clin Immunol. 2007;120:803–12.\nLi R, Yang X, Wang L, Liu E. Respiratory syncytial virus infection reversed anti-asthma effect of neonatal Bacillus Calmette-Guerin vaccination in BALB\u002Fc mice. Pediatr Res. 2006;59:210–5.\nDurrant DM, Gaffen SL, Riesenfeld EP, Irvin CG, Metzger DW. Development of allergen-induced airway inflammation in the absence of T-bet regulation is dependent on IL-17. J Immunol. 2009;183:5293–300.\nLinden A, Adachi M. Neutrophilic airway inflammation and IL-17. Allergy. 2002;57:769–75.\nVon Hertzen L, Klaukka T, Mattila H, Haahtela T. Mycobacterium tuberculosis infection and the subsequent development of asthma and allergic conditions. J Allergy Clin Immunol. 1999;104:1211–4.\nWalzl G, Humphreys IR, Marshall BG, Edwards L, Openshaw PJ, Shaw RJ, et al. Prior exposure to live Mycobacterium bovis BCG decreases Cryptococcus neoformans-induced lung eosinophilia in a gamma interferondependent manner. Infect Immun. 2003;71:3384–91.\nHopfenspirger MT, Agrawal DK. Airway hyperresponsiveness, late allergic response, and eosinophilia are reversed with mycobacterial antigens in ovalbumin-presensitized mice. J Immunol. 2002;168:2516–22.\nYang X, Wang S, Fan Y, Zhu L. Systemic mycobacterial infection inhibits antigen-specific immunoglobulin E production, bronchial mucus production and eosinophilic inflammation induced by allergen. Immunology. 1999;98:329–37.\nEl-Zein M, Parent ME, Benedetti A, Rousseau MC. Does BCG vaccination protect against the development of childhood asthma? A systematic review and meta-analysis of epidemiological studies. Int J Epidemiol. 2010;39:469–86.\nLi J, Luo DF, Li SY, Sun BQ, Zhong NS. Efficacy of intramuscular BCG polysaccharide nucleotide on mild to moderate bronchial asthma accompanied with allergic rhinitis: a randomized, double blind, placebo-controlled study. Chin Med J (Engl). 2005;118:1595–603.\nMarks GB, Ng K, Zhou J, Toelle BG, Xuan W, Belousova EG, et al. The effect of neonatal BCG vaccination on atopy and asthma at age 7 to 14 years: an historical cohort study in a community with a very low prevalence of tuberculosis infection and a high prevalence of atopic disease. J Allergy Clin Immunol. 2003;111:541–9.\nShen H, Huang H, Wang J, Ye S, Li W, Wang K, et al. Neonatal vaccination with Bacillus Calmette-Gue´rin elicits long-term protection in mouse-allergic responses. Allergy. 2008;63:555–63.\nAhrens B, Gruber C, Rha RD, Freund T, Quarcoo D, Awagyan A, et al. BCG priming of dendritic cells enhances T regulatory and Th1 function and suppresses allergen-induced Th2 function in vitro and in vivo. Int Arch Allergy Immunol. 2009;150:210–20.\nHolgate ST, Arshad HS, Roberts GC, Howarth PH, Thurner P, Davies DE. A new look at the pathogenesis of asthma. Clin Sci (Lond). 2009;118:439–50.\nBarnes PJ. Intrinsic asthma: not so different from allergic asthma but driven by superantigens? Clin Exp Allergy. 2009;39:1145–51.\nCohon A, Arruda LK, Martins MA, Guilherme L, Kalil J. Evaluation of BCG administration as an adjuvant to specific immunotherapy in asthmatic children with mite allergy. J Allergy Clin Immunol. 2007;120:210–3.\nLu YJ, Gross J, Bogaert D, Finn A, Bagrade L, Zhang Q, et al. Interleukin-17A mediates acquired immunity to pneumococcal colonization. PLoS Pathog. 4:e1000159.\nWeber SE, Tian H, Pirofski LA. CD8+ cells enhance resistance to pulmonary serotype 3 streptococcus pneumoniae infection in mice. 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Pharmacol Rev 56:249–290, 2004.\nCalvo JR, Pozo D, Guerrero JM: Functional and molecular characterization of VIP receptors and signal transduction in human and rodent immune systems. Adv Neuroimmunol 6:39–47, 1996.\nHarmar AJ, Arimura A, Gozes I, Journot L, Laburthe M, Pisegna JR, Rawlings SR, Robberecht P, Said SI, Sreedharan SP, Wank SA, Waschek JA: International Union of Pharmacology. XVIII. Nomenclature of receptors for vasoactive intestinal peptide and pituitary adenylate cyclase-activating polypeptide. Pharmacol Rev 50:265–270, 1998.\nDelgado M: VIP: A very important peptide in T helper differentiation. Trends Immunol 24:221–224, 2003.\nAbad C, Martinez C, Juarranz MG, Arranz A, Leceta J, Delgado M, Gomariz RP: Therapeutic effects of vasoactive intestinal peptide in the trinitrobenzene sulfonic acid mice model of Crohn’s disease. Gastroenterology 124:961–971, 2003.\nKeino H, Kezuka T, Takeuchi M, Yamakawa N, Hattori T, Usui M: Prevention of experimental autoimmune uveoretinitis by vasoactive intestinal peptide. Arch Ophthalmol 122:1179–1184, 2004.\nDelgado M, Abad C, Martinez C, Leceta J, Gomariz RP: Vasoactive intestinal peptide prevents experimental arthritis by downregulating both autoimmune and inflammatory components of the disease. Nat Med 7:563–568, 2001.\nGiovannoni G, Hartung HP: The immunopathogenesis of multiple sclerosis and Guillain-Barre syndrome. Curr Opin Neurol 9:165–177, 1996.\nZamvil SS, Steinman L: The T lymphocyte in experimental allergic encephalomyelitis. Annu Rev Immunol 8:579–621, 1990.\nSteinman L: Assessment of animal models for MS and demyelinating disease in the design of rational therapy. Neuron 24:511–514, 1999.\nBernard CC, Johns TG, Slavin A, Ichikawa M, Ewing C, Liu J, Bettadapura J: Myelin oligodendrocyte glycoprotein: A novel candidate autoantigen in multiple sclerosis. J Mol Med 75:77–88, 1997.\nWekerle H, Kojima K, Lannes-Vieira J, Lassmann H, Linington C: Animal models. Ann Neurol 36(Suppl):S47–S53, 1994.\nTeresi S, Boudard F, Bastide M: Effect of calcitonin gene-related peptide and vasoactive intestinal peptide on murine CD4 and CD8 T cell proliferation. Immunol Lett 50:105–113, 1996.\nDelgado M, Chorny A, Gonzalez-Rey E, Ganea D: Vasoactive intestinal peptide generates CD4+CD25+ regulatory T cells in vivo. J Leukoc Biol 78:1327–1338, 2005.\nErsoy E, Kus CN, Sener U, Coker I, Zorlu Y: The effects of interferon-beta on interleukin-10 in multiple sclerosis patients. Eur J Neurol 12:208–211, 2005.\nYoussef S, Stuve O, Patarroyo JC, Ruiz PJ, Radosevich JL, Hur EM, Bravo M, Mitchell DJ, Sobel RA, Steinman L, Zamvil SS: The HMG-CoA reductase inhibitor, atorvastatin, promotes a Th2 bias and reverses paralysis in central nervous system autoimmune disease. Nature 420:78–84, 2002.\nDelgado M, Munoz-Elias EJ, Gomariz RP, Ganea D: VIP and PACAP inhibit IL-12 production in LPS-stimulated macrophages. Subsequent effect on IFNgamma synthesis by T cells. J Neuroimmunol 96:167–181, 1999.\nDelgado M, Ganea D: Vasoactive intestinal peptide and pituitary adenylate cyclase-activating polypeptide inhibit interleukin-12 transcription by regulating nuclear factor kappaB and Ets activation. J Biol Chem 274:31930–31940, 1999.\nDelgado M, Leceta J, Gomariz RP, Ganea D: Vasoactive intestinal peptide and pituitary adenylate cyclase-activating polypeptide stimulate the induction of Th2 responses by up-regulating B7.2 expression. J Immunol 163:3629–3635, 1999.\nRanger AM, Das MP, Kuchroo VK, Glimcher LH: B7-2 (CD86) is essential for the development of IL-4-producing T cells. Int Immunol 8:1549–1560, 1996.\nGanea D, Delgado M: Vasoactive intestinal peptide (VIP) and pituitary adenylate cyclase-activating polypeptide (PACAP) as modulators of both innate and adaptive immunity. Crit Rev Oral Biol Med 13:229–237, 2002.\nDelgado M, Leceta J, Ganea D: Vasoactive intestinal peptide and pituitary adenylate cyclase-activating polypeptide promote in vivo generation of memory Th2 cells. FASEB J 16:1844–1846, 2002.\nEugster HP, Frei K, Kopf M, Lassmann H, Fontana A: IL-6-deficient mice resist myelin oligodendrocyte glycoprotein-induced autoimmune encephalomyelitis. Eur J Immunol 28:2178–2187, 1998.\nRansohoff RM: The chemokine system in neuroinflammation: An update. J Infect Dis 186(Suppl 2):S152–S156, 2002.\nDelgado M, Ganea D: Inhibition of endotoxin-induced macrophage chemokine production by vasoactive intestinal peptide and pituitary adenylate cyclase-activating polypeptide in vitro and in vivo. J Immunol 167:966–975, 2001.\nGonzalez-Rey E, Fernandez-Martin A, Chorny A, Martin J, Pozo D, Ganea D, Delgado M: Therapeutic effect of vasoactive intestinal peptide on experimental autoimmune encephalomyelitis: Down-regulation of inflammatory and autoimmune responses. 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HD, Thrasher AJ. The Wiskott-Aldrich syndrome. J Allergy Clin Immunol. 2006;117:725–38.",{"doi":1089},"10.1016\u002Fj.jaci.2006.02.005",{"id":20,"text":1091,"url":20,"identifiers":1092},"Villa A, Notarangelo L, Macchi P, Mantuano E, Cavagni G, Brugnoni D, et al. X-linked thrombocytopenia and Wiskott-Aldrich syndrome are allelic diseases with mutations in the WASP gene. Nat Genet. 1995;9:414–7.",{"doi":1093},"10.1038\u002Fng0495-414",{"id":20,"text":1095,"url":20,"identifiers":1096},"Imai K, Morio T, Zhu Y, Jin Y, Itoh S, Kajiwara M, et al. Clinicalcourse of patients with WASP gene mutations. Blood. 2004;103:456–64.",{"doi":1097},"10.1182\u002Fblood-2003-05-1480",{"id":20,"text":1099,"url":20,"identifiers":1100},"Albert MH, Bittner TC, Nonoyama S, Notarangelo LD, Burns S, Imai K, et al. X-linked thrombocytopenia (XLT) due to WAS mutations: clinical characteristics, long-term outcome, and treatment options. Blood. 2010;115:3231–8.",{"doi":1101},"10.1182\u002Fblood-2009-09-239087",{"id":20,"text":1103,"url":20,"identifiers":1104},"Dupuis-Girod S, Medioni J, Haddad E, Quartier P, Cavazzana-Calvo M, Le Deist F, et al. Autoimmunity in Wiskott-Aldrich syndrome: risk factors, clinical features, and outcome in a single-center cohort of 55 patients. Pediatrics. 2003;111:e622–7.",{"doi":1105},"10.1542\u002Fpeds.111.5.e622",{"id":20,"text":1107,"url":20,"identifiers":1108},"Boyd JK, Cheung CK, Molyneux K, Feehally J, Barratt J. An update on the pathogenesis and treatment of IgA nephropathy. Kidney Int. 2012;81:833–43.",{"doi":1109},"10.1038\u002Fki.2011.501",{"id":20,"text":1111,"url":20,"identifiers":1112},"Kawasaki Y. Mechanism of onset and exacerbation of chronic glomerulonephritis and its treatment. Pediatr Int. 2011;53:795–806.",{"doi":1113},"10.1111\u002Fj.1442-200X.2011.03469.x",{"id":20,"text":1115,"url":20,"identifiers":1116},"Moldoveanu Z, Wyatt RJ, Lee JY, Tomana M, Julian BA, Mestecky J, et al. Patients with IgA nephropathy have increased serum galactose-deficient IgA1 levels. Kidney Int. 2007;71:1148–54.",{"doi":1117},"10.1038\u002Fsj.ki.5002185",{"id":20,"text":1119,"url":20,"identifiers":1120},"Shimizu M, Nikolov NP, Ueno K, Ohta K, Siegel RM, Yachie A, et al. Development of IgA nephropathy-like glomerulonephritis associated with Wiskott-Aldrich syndrome protein deficiency. Clin Immunol. 2012;142:160–6.",{"doi":1121},"10.1016\u002Fj.clim.2011.10.001",{"id":20,"text":1123,"url":20,"identifiers":1124},"Humblet-Baron S, Sather B, Anover S, Becker-Herman S, Kasprowicz DJ, Khim S, et al. Wiskott-Aldrich syndrome protein is required for regulatory T cell homeostasis. J Clin Invest. 2007;117:407–18.",{"doi":1125},"10.1172\u002FJCI29539",{"id":20,"text":1127,"url":20,"identifiers":1128},"Maillard MH, Cotta-de-Almeida V, Takeshima F, Nguyen DD, Michetti P, Nagler C, et al. The Wiskott-Aldrich syndrome protein is required for the function of CD4+CD25+Foxp3+ regulatory T cells. J Exp Med. 2007;204:381–91.",{"doi":1129},"10.1084\u002Fjem.20061338",{"id":20,"text":1131,"url":20,"identifiers":1132},"Trifari S, Sitia G, Aiuti A, Scaramuzza S, Marangoni F, Guidotti LG, et al. Defective Th1 cytokine gene transcription in CD4+ and CD8+ T cells from Wiskott-Aldrich syndrome patients. J Immunol. 2006;177:7451–61.",{"doi":1133},"10.4049\u002Fjimmunol.177.10.7451",{"id":20,"text":1135,"url":20,"identifiers":1136},"Matsukura H, Kanegane H, Miya K, Ohtsubo K, Higuchi A, Tanizawa T, et al. IgA nephropathy associated with X-linked thrombocytopenia. Am J Kidney Dis. 2004;43:e7–12.",{"doi":1137},"10.1053\u002Fj.ajkd.2003.11.016",{"id":20,"text":1139,"url":20,"identifiers":1140},"Shimizu M, Kanegane H, Wada T, Motoyoshi Y, Morio T, Candotti F, et al. Aberrant glycosylation of IgA in Wiskott-Aldrich syndrome and X-linked thrombocytopenia. J Allergy Clin Immunol. 2013;131:587–90.",{"doi":1141},"10.1016\u002Fj.jaci.2012.08.040",{"id":20,"text":1143,"url":20,"identifiers":1144},"Sakai O. IgA nephropathy: current concepts and future trends. Nephrology 1997;3: 2–3.",{},{"id":20,"text":1146,"url":20,"identifiers":1147},"Imasawa T, Nagasawa R, Utsunomiya Y, Kawamura T, Zhong Y, Makita N, et al. Bone marrow transplantation attenuates murine IgA nephropathy: role of a stem cell disorder. Kidney Int. 1999;56:1809–17.",{"doi":1148},"10.1046\u002Fj.1523-1755.1999.00750.x",{"id":20,"text":1150,"url":20,"identifiers":1151},"Suzuki H, Suzuki Y, Aizawa M, Yamanaka T, Kihara M, Pang H, et al. Th1 polarization in murine IgA nephropathy directed by bone marrow-derived cells. Kidney Int. 2007;72:319–27.",{"doi":1152},"10.1038\u002Fsj.ki.5002300",{"id":20,"text":1154,"url":20,"identifiers":1155},"Inoue T, Sugiyama H, Kikumoto Y, Fukuoka N, Maeshima Y, Hattori H, et al. Downregulation of the beta1, 3- galactosyl transferasegene in tonsillar B lymphocytes and aberrant lectin bindings to tonsillar IgA as a pathogenesis of IgA nephropathy. Contrib Nephrol. 2007;157:120–4.",{},{"id":20,"text":1157,"url":20,"identifiers":1158},"Yamada K, Kobayashi N, Ikeda T, Suzuki Y, Tsuge T, Horikoshi S, et al. Down-regulation of core 1 beta1, 3-galactosyl transferase and Cosmc by Th2 cytokine alters O-glycosylation of IgA1. Nephrol Dial Transplant. 2010;25:3890–7.",{"doi":1159},"10.1093\u002Fndt\u002Fgfq325",{"id":20,"text":1161,"url":20,"identifiers":1162},"Suzuki H, Moldoveanu Z, Hall S, Brown R, Vu HL, Novak L, et al. IgA1-secreting cell lines from patients with IgA nephropathy produce aberrantly glycosylated IgA1. J Clin Invest. 2008;118:629–39.",{},{"id":20,"text":1164,"url":20,"identifiers":1165},"Suzuki H, Suzuki Y, Narita I, Aizawa M, Kihara M, Yamanaka T, et al. Toll-like receptor 9 affects severity of IgA nephropathy. J Am Soc Nephrol. 2008;19:2384–95.",{"doi":1166},"10.1681\u002FASN.2007121311",{"id":20,"text":1168,"url":20,"identifiers":1169},"Park HJ, Hahn WH, Suh JS, Kim MJ, Kang SW, Lee JS, et al. Association between toll-like receptor 10 (TLR10) gene polymorphisms and childhood IgA nephropathy. Eur J Pediatr. 2011;170:503–9.",{"doi":1170},"10.1007\u002Fs00431-010-1325-1",{"id":20,"text":1172,"url":20,"identifiers":1173},"Kobayashi I, Nogaki F, Kusano H, Ono T, Miyawaki S, Yoshida H, et al. Interleukin-12 alters the physicochemical characteristics of serum and glomerular IgA and modifies glycosylation in a ddY mouse strain having high IgA levels. Nephrol Dial Transplant. 2002;17:2108–16.",{"doi":1174},"10.1093\u002Fndt\u002F17.12.2108",{"id":20,"text":1176,"url":20,"identifiers":1177},"Cuevas X, Lloveras J, Mir M, Aubia J, Masramon J. Disappearance of mesangial IgA deposits from the kidneys of two donors after transplantation. Transplant Proc. 1987;19:2208–9.",{},{"id":20,"text":1179,"url":20,"identifiers":1180},"Koselj M, Rott T, Kandus A, Vizjak A, Malovrh M. Donor-transmitted IgA nephropathy: long-term follow-up of kidney donors and recipients. Transplant Proc. 1997;29:3406–7.",{"doi":1181},"10.1016\u002FS0041-1345(97)00957-3",{"id":20,"text":1183,"url":20,"identifiers":1184},"Ozsahin H, Cavazzana-Calvo M, Notarangelo LD, Schulz A, Thrasher AJ, Mazzolari E, et al. Long-term outcome following hematopoietic stem-cell transplantation in Wiskott-Aldrich syndrome: collaborative study of the European Society for Immunodeficiencies and European Group for Blood and Marrow Transplantation. Blood. 2008;111:439–45.",{"doi":1185},"10.1182\u002Fblood-2007-03-076679",{"id":1187,"createTime":1188,"updateTime":1189,"relativeEntities":1190,"slug":1191,"properties":1192,"entityType":227,"verifyStatus":228,"verifyTime":1202,"verifyNote":230,"languages":20,"translateLanguages":20,"viewCount":21,"primaryUrl":1203,"fullTextUrl":20,"authors":1204,"publicationType":408,"publisherRelationship":1603,"citationCount":20,"citationInfo":20,"publishDate":1655,"publishYear":579,"citationAnalyzeStatus":754,"lastCitationAnalyze":1656,"indexDatabases":1657,"openAccess":20,"references":20,"isForceReanalyzing":464},"95e78392-178e-47e8-8172-1b53abdab9cf","2024-01-19T19:18:44.447+00:00","2026-08-14T03:55:15.723+00:00",[],"A-Multi-Center-Open-Label-Single-Arm-Trial-to-Evaluate-the-Efficacy-Pharmacokinetics-and-Safety-and-Tolerability-of-IGSC-20-in-Subjects-with-Primary-Immunodeficiency",{"abstract":1193,"title":1195,"gsPaper":1197,"references":1198,"doi":1200},{"EN":1194},"The purpose of this phase 3 study was to evaluate the efficacy, pharmacokinetics (PK), and safety of Immune Globulin Subcutaneous (Human), 20% Caprylate\u002FChromatography Purified (IGSC 20%) in patients with primary immunodeficiency (PI). Immunoglobulin treatment-experienced subjects with PI received 52 weeks of IGSC 20% given weekly at the same dose as the subject’s previous IgG regimen (DAF 1:1); the minimum dose was 100 mg\u002Fkg\u002Fweek. The primary endpoint was serious bacterial infections (SBIs [null vs alternative hypothesis: SBI rate per person per year ≥ 1 vs \u003C 1]). IgG subclasses and specific pathogen antibody levels were also measured. Sixty-one subjects (19 children [≤ 12 years], 10 adolescents [> 12–16 years], and 32 adults) were enrolled. The rate of SBIs per person per year was 0.017. The 1-sided 99% upper confidence limit was 0.036 (\u003C 1), and the null hypothesis was rejected. The rate of hospitalization due to infection per person per year was 0.017 (2-sided 95% confidence interval: 0.008–0.033) overall. The mean trough total IgG concentrations were comparable to the previous IgG replacement regimen. The average of the individual mean trough ratios (IGSC 20%:previous regimen) was 1.078 (range: 0.83–1.54). The average steady-state mean trough IgG concentrations were 947.64 and 891.37 mg\u002FdL, respectively. Seven subjects had serious treatment-emergent adverse events (TEAEs); none was drug-related. The rate of all TEAEs, including local infusion site reactions, during 3045 IGSC 20% infusions was 0.135. Most TEAEs were mild or moderate. IGSC 20% demonstrated efficacy and good safety and tolerability in subjects with PI.",{"EN":1196},"A Multi‑Center, Open‑Label, Single‑Arm Trial to Evaluate the Efficacy, Pharmacokinetics, and Safety and Tolerability of IGSC 20% in Subjects with Primary Immunodeficiency",{"VOID":622},{"VOID":1199},"Buckley RH, Schiff RI. The use of intravenous immune globulin in immunodeficiency diseases. N Engl J Med. 1991;325(2):110–7. https:\u002F\u002Fdoi.org\u002F10.1056\u002Fnejm199107113250207.\nSacher RA. Intravenous immunoglobulin consensus statement. J Allergy Clin Immunol. 2001;108(4 Suppl):S139–46. https:\u002F\u002Fdoi.org\u002F10.1067\u002Fmai.2001.118640.\nGardulf A. Immunoglobulin treatment for primary antibody deficiencies: advantages of the subcutaneous route. BioDrugs. 2007;21(2):105–16. https:\u002F\u002Fdoi.org\u002F10.2165\u002F00063030-200721020-00005.\nHelbert M, Farragher A. Subcutaneous immunoglobulin for patients with antibody deficiency. Br J Hosp Med (Lond). 2007;68(4):206–10. https:\u002F\u002Fdoi.org\u002F10.12968\u002Fhmed.2007.68.4.206.\nOchs HD, Gupta S, Kiessling P, Nicolay U, Berger M. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006;26(3):265–73. https:\u002F\u002Fdoi.org\u002F10.1007\u002Fs10875-006-9021-7.\nBoyle M, Scalchunes C. Impact of intervenous immunoglobulin (IVIG) treatment among patients with Primary Immunodeficiency diseases. Pharmaceuticals Policy and Law. 2008;10:133–46.\nBerger M. Subcutaneous immunoglobulin replacement in primary immunodeficiencies. Clin Immunol. 2004;112(1):1–7. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.clim.2004.02.002.\nChapel HM, Spickett GP, Ericson D, Engl W, Eibl MM, Bjorkander J. The comparison of the efficacy and safety of intravenous versus subcutaneous immunoglobulin replacement therapy. J Clin Immunol. 2000;20(2):94–100. https:\u002F\u002Fdoi.org\u002F10.1023\u002Fa:1006678312925.\nChinen J, Shearer WT. Subcutaneous immunoglobulins: alternative for the hypogammaglobulinemic patient? J Allergy Clin Immunol. 2004;114(4):934–5. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.jaci.2004.07.045.\nChouksey A, Duff K, Wasserbauer N, Berger M. Subcutaneous immunoglobulin-g replacement therapy with preparations currently available in the United States for intravenous or intramuscular use: reasons and regimens. Allergy Asthma Clin Immunol. 2005;1(3):120–30. https:\u002F\u002Fdoi.org\u002F10.1186\u002F1710-1492-1-3-120.\nGardulf A, Andersen V, Bjorkander J, Ericson D, Froland SS, Gustafson R, et al. Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs. Lancet. 1995;345(8946):365–9. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fs0140-6736(95)90346-1.\nGardulf A, Nicolay U, Math D, Asensio O, Bernatowska E, Bock A, et al. Children and adults with primary antibody deficiencies gain quality of life by subcutaneous IgG self-infusions at home. J Allergy Clin Immunol. 2004;114(4):936–42. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.jaci.2004.06.053.\nGardulf A, Nicolay U. Replacement IgG therapy and self-therapy at home improve the health-related quality of life in patients with primary antibody deficiencies. Curr Opin Allergy Clin Immunol. 2006;6(6):434–42. https:\u002F\u002Fdoi.org\u002F10.1097\u002F01.all.0000246619.49494.41.\nGardulf A, Nicolay U, Asensio O, Bernatowska E, Bock A, Carvalho BC, et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies–a prospective, multi-national study. J Clin Immunol. 2006;26(2):177–85. https:\u002F\u002Fdoi.org\u002F10.1007\u002Fs10875-006-9002-x.\nHansen S, Gustafson R, Smith CI, Gardulf A. Express subcutaneous IgG infusions: decreased time of delivery with maintained safety. Clin Immunol. 2002;104(3):237–41. https:\u002F\u002Fdoi.org\u002F10.1006\u002Fclim.2002.5215.\nNicolay U, Haag S, Eichmann F, Herget S, Spruck D, Gardulf A. Measuring treatment satisfaction in patients with primary immunodeficiency diseases receiving lifelong immunoglobulin replacement therapy. Qual Life Res. 2005;14(7):1683–91. https:\u002F\u002Fdoi.org\u002F10.1007\u002Fs11136-005-1746-x.\nHagan JB, Fasano MB, Spector S, Wasserman RL, Melamed I, Rojavin MA, et al. Efficacy and safety of a new 20% immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J Clin Immunol. 2010;30(5):734–45. https:\u002F\u002Fdoi.org\u002F10.1007\u002Fs10875-010-9423-4.\nJolles S, Bernatowska E, de Gracia J, Borte M, Cristea V, Peter HH, et al. Efficacy and safety of Hizentra((R)) in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clin Immunol. 2011;141(1):90–102. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.clim.2011.06.002.\nJolles S, Borte M, Nelson RP Jr, Rojavin M, Bexon M, Lawo JP, et al. Long-term efficacy, safety, and tolerability of Hizentra(R) for treatment of primary immunodeficiency disease. Clin Immunol. 2014;150(2):161–9. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.clim.2013.10.008.\nRadinsky S, Bonagura VR. Subcutaneous immunoglobulin infusion as an alternative to intravenous immunoglobulin. J Allergy Clin Immunol. 2003;112(3):630–3. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fs0091-6749(03)01781-0.\nStiehm ER, Casillas AM, Finkelstein JZ, Gallagher KT, Groncy PM, Kobayashi RH, et al. Slow subcutaneous human intravenous immunoglobulin in the treatment of antibody immunodeficiency: use of an old method with a new product. J Allergy Clin Immunol. 1998;101(6 Pt 1):848–9. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fs0091-6749(98)70314-8.\nBorte M, Krivan G, Derfalvi B, Marodi L, Harrer T, Jolles S, et al. Efficacy, safety, tolerability and pharmacokinetics of a novel human immune globulin subcutaneous, 20%: a Phase 2\u002F3 study in Europe in patients with primary immunodeficiencies. Clin Exp Immunol. 2017;187(1):146–59. https:\u002F\u002Fdoi.org\u002F10.1111\u002Fcei.12866.\nSuez D, Stein M, Gupta S, Hussain I, Melamed I, Paris K, et al. Efficacy, safety, and pharmacokinetics of a novel human immune globulin subcutaneous, 20 % in patients with primary immunodeficiency diseases in North America. J Clin Immunol. 2016;36(7):700–12. https:\u002F\u002Fdoi.org\u002F10.1007\u002Fs10875-016-0327-9.\nThomas MJ, Brennan VM, Chapel HH. Rapid subcutaneous immunoglobulin infusions in children. Lancet. 1993;342(8884):1432–3. https:\u002F\u002Fdoi.org\u002F10.1016\u002F0140-6736(93)92798-x.\nSleasman JW, Lumry WR, Hussain I, Wedner HJ, Harris JB, Courtney KL, et al. Immune globulin subcutaneous, human - klhw 20% for primary humoral immunodeficiency: an open-label. Phase III study Immunotherapy. 2019;11(16):1371–86. https:\u002F\u002Fdoi.org\u002F10.2217\u002Fimt-2019-0159.\nEuropean Medicines Agency. Guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and\u002For intramuscular administration (SCIg\u002FIMIg). Available at: https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fdocuments\u002Fscientific-guideline\u002Fguideline-clinical-investigation-human-normal-immunoglobulin-subcutaneous\u002Fintramuscular-administration-scig\u002Fimig_en.pdf. Accessed November 3, 2021.\nSeidel MG, Kindle G, Gathmann B, Quinti I, Buckland M, van Montfrans J, et al. The European Society for Immunodeficiencies (ESID) registry working definitions for the clinical diagnosis of inborn errors of immunity. J Allergy Clin Immunol Pract. 2019;7(6):1763–70. https:\u002F\u002Fdoi.org\u002F10.1016\u002Fj.jaip.2019.02.004.\nUS Department of Health and Human Services, Food and Drug Administration, and Center for Biologics Evaluation and Research. Guidance for industry: safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency. June 2008. Available at: https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F124333\u002Fdownload. Accessed November 3, 2021.\nARUP Laboratories. Diphtheria, Tetanus, and H. Influenzae b Antibodies, IgG. Available at: https:\u002F\u002Fltd.aruplab.com\u002FTests\u002FPub\u002F0050779. Accessed November 3, 2021.\nGowin E, Wysocki J, Kaluzna E, Swiatek-Koscielna B, Wysocka-Leszczynska J, Michalak M, et al. Does vaccination ensure protection? Assessing diphtheria and tetanus antibody levels in a population of healthy children: a cross-sectional study. Medicine (Baltimore). 2016;95(49): e5571. https:\u002F\u002Fdoi.org\u002F10.1097\u002Fmd.0000000000005571.\nBoyle J, Shearer W. Immune Globulin Potency in the 21st Century. Session III: Immune Globulin Potency Testing -- The Future. Rockville, Maryland. 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Clinical course of patients with WASP gene mutations. Blood. 2004;103:456–64.\nLiu CH, Wu KH, Lin TY, Wei CC, Lin CY, Chen XX, et al. Wiskott-Aldrich syndrome with IgA nephropathy: a case report and literature review. Int Urol Nephrol. 2013;45:1495–500.\nChovancova Z, Kuman M, Vlkova M, Litzman J. Successful renal transplantation in a patient with a Wiskott-Aldrich syndrome protein (WASP) gene mutation. Transpl Int. 2015;28:1005–9.\nShimizu M, Nikolov NP, Ueno K, Ohta K, Siegel RM, Yachie A, et al. Development of IgA nephropathy-like glomerulonephritis associated with Wiskott-Aldrich syndrome protein deficiency. Clin Immunol. 2012;142:160–6.\nZand L, Fervenza FC, Nasr SH, Sethi S. Membranoproliferative glomerulonephritis associated with autoimmune diseases. J Nephrol. 2014;27:165–71.\nBurns S, Cory GO, Vainchenker W, Thrasher AJ. Mechanisms of WASp-mediated hematologic and immunologic disease. 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licensing studies of subcutaneous IgG (SCIG) calculate dose adjustments necessary to achieve area under the curve (AUC) of serum IgG vs. time on SCIG that is non-inferior to that on intravenous IgG (IVIG), within the FDA-set limit of ±20 %. The results are interpreted as showing that different SCIGs differ in bioavailability. We used three approaches to determine if the bioavailabilities were actually different. Dose adjustments and AUCs from published licensing studies were used to calculate bioavailabilities using the formula: Bioavailability (% of IVIG) = AUC(SCIG) ÷ AUC(IVIG) x 1\u002FDose Adjustment. We also compared the increment in serum IgG concentration achieved with varying doses of SCIG in recent meta-analyses with the increment with different doses of IVIG, and determined the serum IgG concentrations when patients switched SCIG products at the same dose. The actual bioavailabilities were: Gamunex® 65.0 %, Hizentra® 65.5 %, Gammagard® 67.2 %, Vivaglobin® 69.0 %. Regression analyses of serum IgG vs. dose showed that the mean increase in serum IgG resulting from a 100 mg\u002Fkg\u002Fmonth increment in SCIG dosing was 69.4 % of the increase with the same increment in IVIG dosing (84 mg\u002FdL vs. 121 mg\u002FdL). Patients switching SCIG preparations at the same dose had no change in serum IgG levels, confirming that bioavailabilities of the SCIG preparations did not differ. Decreased bioavailability appears to be a basic property of SCIG and not a result of any manufacturing process or concentration. Because serum IgG levels do not vary with different SCIG products at the same dose, adjustments are not necessary when switching products.",{"EN":1818},"Bioavailability of IgG Administered by the Subcutaneous Route",{"VOID":1820},"[\"15157309966060875038\"]",{"VOID":1822},"Aebersold P. Regulatory requirements for subcutaneous Ig for PID. In: Intravenous immunoglobulins in the 21st century: progress and challenges in efficacy, safety and paths to licensure. FDA workshop. 2005. http:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FBiologicsBloodVaccines\u002FNewsEvents\u002FWorkshopsMeetingsConferences\u002FTranscriptsMinutes\u002FUCM054437.pdf. Accessed 8 Nov 2012.\nWang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin Pharmacol Ther. 2008;84:548–58.\nBerger M, Rojavin M, Kiessling P, Zenker O. Pharmacokinetics of subcutaneous immunoglobulin and their use in dosing of replacement therapy in patients with primary immunodeficiencies. Clin Immunol. 2011;139:133–41.\nWasserman RL, Melamed I, Nelson RP, et al. Pharmacokinetics of subcutaneous IgPro20 in patients with primary immunodeficiency. Clin Pharmacokinet. 2011;50:405–14.\nWasserman RL, Irani AM, Tracy J, et al. Pharmacokinetics and safety of subcutaneous immune globulin (human), 10 % caprylate\u002Fchromatography purified in patients with primary immunodeficiency disease. Clin Exp Immunol. 2010;161:518–26.\nWasserman RL, Melamed I, Kobrynski L, et al. Efficacy, safety, and pharmacokinetics of a 10 % liquid immune globulin preparation (GAMMAGARD LIQUID, 10 %) administered subcutaneously in subjects with primary immunodeficiency disease. J Clin Immunol. 2011;31:323–31.\nOchs HD, Gupta S, Kiessling P, Nicolay U, Berger M. Safety and efficacy of self-administered subcutaneous immunoglobulin in patients with primary immunodeficiency diseases. J Clin Immunol. 2006;26:265–73.\nHagan JB, Fasano MB, Spector S, et al. Efficacy and safety of a new 20 % immunoglobulin preparation for subcutaneous administration, IgPro20, in patients with primary immunodeficiency. J Clin Immunol. 2010;30:734–45.\nLucas M, Hugh-Jones K, Welby A, et al. Immunomodulatory therapy to achieve maximum efficacy: doses, monitoring, compliance, and self-infusion at home. J Clin Immunol. 2010;30 Suppl 1:S84–9.\nBonilla FA. Pharmacokinetics of immunoglobulin administered via intravenous or subcutaneous routes. Immunol Allergy Clin North Am. 2008;28:803–19. ix.\nHoffmann F, Grimbacher B, Thiel J, Peter HH, Belohradsky BH. Home-based subcutaneous immunoglobulin G replacement therapy under real-life conditions in children and adults with antibody deficiency. Eur J Med Res. 2010;15:238–45.\nGardulf A, Nicolay U, Asensio O, et al. Rapid subcutaneous IgG replacement therapy is effective and safe in children and adults with primary immunodeficiencies–a prospective, multi-national study. J Clin Immunol. 2006;26:177–85.\nOrange JS, Grossman WJ, Navickis RJ, Wilkes MM. Impact of trough IgG on pneumonia incidence in primary immunodeficiency: a meta-analysis of clinical studies. Clin Immunol. 2010;137:21–30.\nOrange JS, Belohradsky BH, Berger M, et al. Evaluation of correlation between dose and clinical outcomes in subcutaneous immunoglobulin replacement therapy. Clin Exp Immunol. 2012;169:172–81.\nJolles S, Bernatowska E, de Gracia J, et al. Efficacy and safety of Hizentra® in patients with primary immunodeficiency after a dose-equivalent switch from intravenous or subcutaneous replacement therapy. Clin Immunol. 2011;141:90–102.\nNguyen D, Dorsey T, Alberdi C, Duff J, Sleasman JW. Subcutaneous Hizentra® (20%) is better tolerated and shares similar efficacy compared to subcutaneous Vivaglobin® (16%). J Allergy Clin Immunol. 2012;129:AB15.\nvon Behring E. Serum therapy in therapeutics and medical science. Nobel lecture. 1901. http:\u002F\u002Fnobelprize.org\u002Fnobel_prizes\u002Fmedicine\u002Flaureates\u002F1901\u002Fbehring-lecture.html. Accessed 27 Nov 2012.\nEmu B, Luca D, Offutt C, et al. Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin alpha: results of a phase I randomized, placebo-controlled trial. Arthritis Res Ther. 2012;14:R6.\nZhou H. Clinical pharmacokinetics of etanercept: a fully humanized soluble recombinant tumor necrosis factor receptor fusion protein. J Clin Pharmacol. 2005;45:490–7.\nAbolhassani H, Sadaghiani MS, Aghamohammadi A, Ochs HD, Rezaei N. Home-based subcutaneous immunoglobulin versus hospital-based intravenous immunoglobulin in treatment of primary antibody deficiencies: systematic review and meta analysis. J Clin Immunol. 2012.\nDesai SH, Chouksey A, Poll J, Berger M. A pilot study of equal doses of 10 % IGIV given intravenously or subcutaneously. J Allergy Clin Immunol. 2009;124:854–6.\nThepot S, Malphettes M, Gardeur A, et al. Immunoglobulin dosage and switch from intravenous to subcutaneous immunoglobulin replacement therapy in patients with primary hypogammaglobulinemia: decreasing dosage does not alter serum IgG levels. J Clin Immunol. 2010;30:602–6.\nBerger M. Incidence of infection is inversely related to steady-state (trough) serum IgG level in studies of subcutaneous IgG in PIDD. J Clin Immunol. 2011;31:924–6.\nBonagura VR, Marchlewski R, Cox A, Rosenthal DW. Biologic IgG level in primary immunodeficiency disease: the IgG level that protects against recurrent infection. J Allergy Clin Immunol. 2008;122:210–2.\nLucas M, Lee M, Lortan J, et al. Infection outcomes in patients with common variable immunodeficiency disorders: relationship to immunoglobulin therapy over 22 years. J Allergy Clin Immunol. 2010;125:1354–60.",{"VOID":1824},"10.1007\u002Fs10875-013-9876-3","2024-06-24T08:58:18.510+00:00","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1007\u002Fs10875-013-9876-3",[1828,1845,1860,1875],{"id":1829,"sortIndex":21,"researcher":20,"roles":1830,"affiliations":1831,"properties":1840,"displayName":1842,"givenName":20,"familyName":20},"a225694c-3fc4-4b0b-a797-5b1d6ef6d346",[238],[1832],{"id":1833,"sortIndex":21,"affiliation":1834,"properties":20},"df837d1f-d222-4b43-a3b8-5991bbfb64e9",{"id":1833,"createTime":20,"updateTime":20,"relativeEntities":1835,"slug":20,"properties":1836,"entityType":20,"verifyStatus":20,"verifyTime":20,"verifyNote":20,"languages":20,"translateLanguages":20,"viewCount":20,"url":20,"parentIds":1839,"statistic":20},[],{"title":1837},{"VI":1838},"CSL Behring LLC, King of Prussia, USA",[],{"title":1841,"gsAuthor":1843},{"VI":1842},"Melvin Berger",{"VOID":1844},"[\"nWFof9gAAAAJ\"]",{"id":1846,"sortIndex":182,"researcher":20,"roles":1847,"affiliations":1848,"properties":1857,"displayName":1859,"givenName":20,"familyName":20},"678e7439-ef4d-4199-9264-48dcba9afdc1",[238],[1849],{"id":1850,"sortIndex":21,"affiliation":1851,"properties":20},"d0e522fc-63a6-4d5d-a700-80ffcaff499f",{"id":1850,"createTime":20,"updateTime":20,"relativeEntities":1852,"slug":20,"properties":1853,"entityType":20,"verifyStatus":20,"verifyTime":20,"verifyNote":20,"languages":20,"translateLanguages":20,"viewCount":20,"url":20,"parentIds":1856,"statistic":20},[],{"title":1854},{"VI":1855},"Department of Medical Biochemistry and Immunology, University Hospital of Wales, Cardiff, UK",[],{"title":1858},{"VI":1859},"Stephen Jolles",{"id":1861,"sortIndex":266,"researcher":20,"roles":1862,"affiliations":1863,"properties":1872,"displayName":1874,"givenName":20,"familyName":20},"6de8a50e-671e-4414-ade0-0d205b451888",[238],[1864],{"id":1865,"sortIndex":21,"affiliation":1866,"properties":20},"3342c1ae-7beb-4b9f-b979-41981fa14274",{"id":1865,"createTime":20,"updateTime":20,"relativeEntities":1867,"slug":20,"properties":1868,"entityType":20,"verifyStatus":20,"verifyTime":20,"verifyNote":20,"languages":20,"translateLanguages":20,"viewCount":20,"url":20,"parentIds":1871,"statistic":20},[],{"title":1869},{"VI":1870},"Texas Children’s Hospital, Section of Immunology Allergy and Rheumatology, Baylor College of Medicine, Houston, USA",[],{"title":1873},{"VI":1874},"Jordan S. Orange",{"id":1876,"sortIndex":280,"researcher":20,"roles":1877,"affiliations":1878,"properties":1887,"displayName":1889,"givenName":20,"familyName":20},"3fdc1403-ead4-4929-bab0-848c6919344d",[238],[1879],{"id":1880,"sortIndex":21,"affiliation":1881,"properties":20},"4ccbbf4b-12a4-442d-9174-fcd9e83f0c53",{"id":1880,"createTime":20,"updateTime":20,"relativeEntities":1882,"slug":20,"properties":1883,"entityType":20,"verifyStatus":20,"verifyTime":20,"verifyNote":20,"languages":20,"translateLanguages":20,"viewCount":20,"url":20,"parentIds":1886,"statistic":20},[],{"title":1884},{"VI":1885},"Department of Pediatrics, University of South Florida, St. Petersburg, USA",[],{"title":1888},{"VI":1889},"John W. 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pathogenesis of hepatitis B virus (HBV)-associated chronic liver disease is still not fully understood. The immune imbalance of cytokine profile exerts a profound influence on the resolution of HBV infections and HBV clearance. This present study aimed to evaluate the immune status of the peripheral T helper (Th) 17 and Th1 cells in the active patients with chronic HBV infection. Thirty patients with chronic active hepatitis B were included in our present study. The frequency of peripheral Th 17 cells (CD3+CD8−IL-17+ T cells), Th1 cells (CD3+CD8−IFN-γ+ T cells), and Tc1 cells (CD3+CD8+IFN-γ+ T cells) in chronic hepatitis B (CHB) were analyzed by flow cytometry. The protein and mRNA levels of interleukin-17 (IL-17) and interferon-gamma (IFN-γ) were measured by enzyme-linked immunosorbent assay and quantitative real-time polymerase chain reaction (PCR). The percentage of Th17 cells in peripheral blood of CHB patients (1.53 ± 0.52%) was significantly increased than that in normal controls (0.92 ± 0.20%; P \u003C 0.05). In contrast, the percentage of Th1 and Tc1 cells of CHB patients was significantly decreased as compared with that of control group. The frequency of Th17 cells had a negative correlation with Th1 cells, and a positive correlation with serum alanine aminotransferase in CHB patients. The elevated peripheral Th17 cells were obtained in the patient with chronic active hepatitis B, suggesting its potential role in the immune activation of chronic HBV infection.",{"EN":1959},"Implication of Th17 and Th1 Cells in Patients with Chronic Active Hepatitis B",{"VOID":622},{"VOID":1962},"Lok AS. The maze of treatments for hepatitis B. N Engl J Med. 2005;352:2743–6.\nKägi D, Ledermann B, Bürki K, Zinkernagel RM, Hengartner H. Molecular mechanisms of lymphocyte-mediated cytotoxicity and their role in immunological protection and pathogenesis in vivo. Annu Rev Immunol. 1996;14:207–32.\nVierling JM. The immunology of hepatitis B. Clin Liver Dis. 2007;11:727–59.\nKlein J, Sato A. The HLA system. First of two parts. N Engl J Med. 2000;343:702–9.\nKlein J, Sato A. The HLA system. Second of two parts. N Engl J Med. 2000;343:782–6.\nHarrington LE, Hatton RD, Mangan PR, Turner H, Murphy TL, Murphy KM, et al. Interleukin 17-producing CD4+ effector T cells develop via a lineage distinct from the T helper type 1 and 2 lineages. Nat Immunol. 2005;6:1123–32.\nPark H, Li Z, Yang XO, Chang SH, Nurieva R, Wang YH, et al. A distinct lineage of CD4 T cells regulates tissue inflammation by producing interleukin 17. Nat Immunol. 2005;6:1133–41.\nOuyang W, Kolls JK, Zheng Y. The biological functions of T helper 17 cell effector cytokines in inflammation. Immunity. 2008;28:454–67.\nDong C. TH17 cells in development: an updated view of their molecular identity and genetic programming. Nat Rev Immunol. 2008;8:337–48.\nIvanov II, McKenzie BS, Zhou L, Tadokoro CE, Lepelley A, Lafaille JJ, et al. The orphan nuclear receptor RORgammat directs the differentiation program of proinflammatory IL-17+ T helper cells. Cell. 2006;126:1121–33.\nMartinez GJ, Nurieva RI, Yang XO, Dong C. Regulation and function of proinflammatory TH17 cells. Ann N Y Acad Sci. 2008;1143:188–211.\nKolls JK, Linden A. Interleukin-17 family members and inflammation. Immunity. 2004;21:467–76.\nLangrish CL, Chen Y, Blumenschein WM, Mattson J, Basham B, Sedgwick JD, et al. IL-23 drives a pathogenic T cell population that induces autoimmune inflammation. J Exp Med. 2005;201:233–40.\nMa D, Zhu X, Zhao P, Zhao C, Li X, Zhu Y, et al. Profile of Th17 cytokines (IL-17, TGF-beta, IL-6) and Th1 cytokine (IFN-gamma) in patients with immune thrombocytopenic purpura. Ann Hematol. 2008;87:899–904.\nZhang B, Rong G, Wei H, Zhang M, Bi J, Ma L, et al. The prevalence of Th17 cells in patients with gastric cancer. Biochem Biophys Res Commun. 2008;374:533–7.\nLemmers A, Moreno C, Gustot T, Maréchal R, Degré D, Demetter P, et al. The interleukin-17 pathway is involved in human alcoholic liver disease. Hepatology. 2009;49:646–57.\nPenna A, Del Prete G, Cavalli A, Bertoletti A, D’Elios MM, Sorrentino R, et al. Predominant T-helper 1 cytokine profile of hepatitis B virus nucleocapsid-specific T cells in acute self-limited hepatitis B. Hepatology. 1997;25:1022–7.\nZajac AJ, Murali-Krishna K, Blattman JN, Ahmed R. Therapeutic vaccination against chronic viral infection: the importance of cooperation between CD4+ and CD8+ T cells. Curr Opin Immunol. 1998;10:444–9.\nFerrari C, Missale G, Boni C, Urbani S. Immunopathogenesis of hepatitis B. J Hepatol. 2003;39(Suppl 1):S36–S42.\nLöhr HF, Krug S, Herr W, Weyer S, Schlaak J, Wölfel T, et al. Quantitative and functional analysis of core-specific T-helper cell and CTL activities in acute and chronic hepatitis B. Liver. 1998;18:405–13.\nKondo Y, Kobayashi K, Ueno Y, Shiina M, Niitsuma H, Kanno N, et al. Mechanism of T cell hyporesponsiveness to HBcAg is associated with regulatory T cells in chronic hepatitis B. World J Gastroenterol. 2006;12:4310–7.\nAkpolat N, Yahsi S, Godekmerdan A, Demirbag K, Yalniz M. Relationship between serum cytokine levels and histopathological changes of liver in patients with hepatitis B. World J Gastroenterol. 2005;11:3260–3.\nJiang R, Feng X, Guo Y, Lu Q, Hou J, Luo K, et al. T helper cells in patients with chronic hepatitis B virus infection. Chin Med J (Engl). 2002;115:422–4.\nBettelli E, Oukka M, Kuchroo VK. T(H)-17 cells in the circle of immunity and autoimmunity. Nat Immunol. 2007;8:345–50.\nShahrara S, Huang Q, Mandelin AM 2nd, Pope RM. TH-17 cells in rheumatoid arthritis. Arthritis Res Ther. 2008;10:R93.\nPrussin C. Cytokine flow cytometry: understanding cytokine biology at the single-cell level. J Clin Immunol. 1997;17:195–204.\nPène J, Chevalier S, Preisser L, Vénéreau E, Guilleux MH, Ghannam S, et al. Chronically inflamed human tissues are infiltrated by highly differentiated Th17 lymphocytes. J Immunol. 2008;180:7423–30.\nLuger D, Silver PB, Tang J, Cua D, Chen Z, Iwakura Y, et al. Either a Th17 or a Th1 effector response can drive autoimmunity: conditions of disease induction affect dominant effector category. J Exp Med. 2008;205:799–810.\nBertoletti A, Costanzo A, Chisari FV, Levrero M, Artini M, Sette A, et al. Cytotoxic T lymphocyte response to a wild type hepatitis B virus epitope in patients chronically infected by variant viruses carrying substitutions within the epitope. J Exp Med. 1994;180:933–43.\nYan MX, Mao HT, Liu Q, Wang WQ, Li YQ. Elevated levels of serum soluble E-selectin in patients with chronic hepatitis B: correlation with T lymphocyte subsets, NK cells and liver inflammation. Hepatol Res. 2006;35:111–7.\nTang TJ, Kwekkeboom J, Laman JD, Niesters HG, Zondervan PE, de Man RA, et al. The role of intrahepatic immune effector cells in inflammatory liver injury and viral control during chronic hepatitis B infection. J Viral Hepat. 2003;10:159–67.\nKim WR, Flamm SL, Di Bisceglie AM, Bodenheimer HC. Serum activity of alanine aminotransferase (ALT) as an indicator of health and disease. Hepatology. 2008;47:1363–70.\nXu Y, Du WJ, Qin LY, Xing ZZ, Qin XH, Chen SJ. Expression of interleukin-17 in hepatitis B related liver fibrosis. Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2009;25:133–5.",{"VOID":1964},"10.1007\u002Fs10875-009-9328-2","2024-06-25T15:10:27.319+00:00","https:\u002F\u002Flink.springer.com\u002Farticle\u002F10.1007\u002Fs10875-009-9328-2",[1968,1983,1996,2011,2024,2037],{"id":1969,"sortIndex":21,"researcher":20,"roles":1970,"affiliations":1971,"properties":1980,"displayName":1982,"givenName":20,"familyName":20},"400b336b-908d-4b09-a2ab-fa9e7b57c14a",[238],[1972],{"id":1973,"sortIndex":21,"affiliation":1974,"properties":20},"6485d15f-bc79-4d53-8833-4fbe4756c234",{"id":1973,"createTime":20,"updateTime":20,"relativeEntities":1975,"slug":20,"properties":1976,"entityType":20,"verifyStatus":20,"verifyTime":20,"verifyNote":20,"languages":20,"translateLanguages":20,"viewCount":20,"url":20,"parentIds":1979,"statistic":20},[],{"title":1977},{"VI":1978},"Department of Hepatology, Qilu Hospital, Shandong University, Jinan, China",[],{"title":1981},{"VI":1982},"Jian Ge",{"id":1984,"sortIndex":182,"researcher":20,"roles":1985,"affiliations":1986,"properties":1993,"displayName":1995,"givenName":20,"familyName":20},"f18fa2a1-a4c8-4c7f-95a6-2259d3a91d14",[238],[1987],{"id":1973,"sortIndex":21,"affiliation":1988,"properties":20},{"id":1973,"createTime":20,"updateTime":20,"relativeEntities":1989,"slug":20,"properties":1990,"entityType":20,"verifyStatus":20,"verifyTime":20,"verifyNote":20,"languages":20,"translateLanguages":20,"viewCount":20,"url":20,"parentIds":1992,"statistic":20},[],{"title":1991},{"VI":1978},[],{"title":1994},{"VI":1995},"Kai 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Meng",{"id":2012,"sortIndex":280,"researcher":20,"roles":2013,"affiliations":2014,"properties":2021,"displayName":2023,"givenName":20,"familyName":20},"c3420988-c11a-4028-89aa-75d9b6a43fb7",[238],[2015],{"id":1973,"sortIndex":21,"affiliation":2016,"properties":20},{"id":1973,"createTime":20,"updateTime":20,"relativeEntities":2017,"slug":20,"properties":2018,"entityType":20,"verifyStatus":20,"verifyTime":20,"verifyNote":20,"languages":20,"translateLanguages":20,"viewCount":20,"url":20,"parentIds":2020,"statistic":20},[],{"title":2019},{"VI":1978},[],{"title":2022},{"VI":2023},"Zhao-Xia 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