Clinical trial NCT02505009 - References

Chronic Hepatitis B — Efficacy of HBV Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy

Citation(s)

•   Beasley RP, Hwang LY, Lin CC, Ko YC, Twu SJ
  Incidence of hepatitis among students at a university in Taiwan. Am J Epidemiol. 1983 Feb;117(2):213-22.
•   Beasley RP, Hwang LY, Lin CC, Leu ML, Stevens CE, Szmuness W, Chen KP
  Incidence of hepatitis B virus infections in preschool children in Taiwan. J Infect Dis. 1982 Aug;146(2):198-204.
•   Bertoletti A, Ferrari C
  Innate and adaptive immune responses in chronic hepatitis B virus infections: towards restoration of immune control of viral infection. Gut. 2012 Dec;61(12):1754-64. doi: 10.1136/gutjnl-2011-301073. Epub 2011 Dec 9. Review.
•   Bertoletti A, Kennedy PT
  The immune tolerant phase of chronic HBV infection: new perspectives on an old concept. Cell Mol Immunol. 2015 May;12(3):258-63. doi: 10.1038/cmi.2014.79. Epub 2014 Sep 1. Review.
•   Boni C, Penna A, Bertoletti A, Lamonaca V, Rapti I, Missale G, Pilli M, Urbani S, Cavalli A, Cerioni S, Panebianco R, Jenkins J, Ferrari C
  Transient restoration of anti-viral T cell responses induced by lamivudine therapy in chronic hepatitis B. J Hepatol. 2003 Oct;39(4):595-605. Erratum in: J Hepatol. 2004 Jun;40(6):1053-4.
•   Boni C, Penna A, Ogg GS, Bertoletti A, Pilli M, Cavallo C, Cavalli A, Urbani S, Boehme R, Panebianco R, Fiaccadori F, Ferrari C
  Lamivudine treatment can overcome cytotoxic T-cell hyporesponsiveness in chronic hepatitis B: new perspectives for immune therapy. Hepatology. 2001 Apr;33(4):963-71.
•   Buchmann P, Dembek C, Kuklick L, Jäger C, Tedjokusumo R, von Freyend MJ, Drebber U, Janowicz Z, Melber K, Protzer U
  A novel therapeutic hepatitis B vaccine induces cellular and humoral immune responses and breaks tolerance in hepatitis B virus (HBV) transgenic mice. Vaccine. 2013 Feb 6;31(8):1197-203. doi: 10.1016/j.vaccine.2012.12.074. Epub 2013 Jan 7.
•   Burk RD, Hwang LY, Ho GY, Shafritz DA, Beasley RP
  Outcome of perinatal hepatitis B virus exposure is dependent on maternal virus load. J Infect Dis. 1994 Dec;170(6):1418-23.
•   Chang SW, Fann CS, Su WH, Wang YC, Weng CC, Yu CJ, Hsu CL, Hsieh AR, Chien RN, Chu CM, Tai DI
  A genome-wide association study on chronic HBV infection and its clinical progression in male Han-Taiwanese. PLoS One. 2014 Jun 18;9(6):e99724. doi: 10.1371/journal.pone.0099724. eCollection 2014.
•   Chen CJ, Wang LY, Yu MW
  Epidemiology of hepatitis B virus infection in the Asia-Pacific region. J Gastroenterol Hepatol. 2000 May;15 Suppl:E3-6.
•   Cholongitas E, Goulis J, Akriviadis E, Papatheodoridis GV
  Hepatitis B immunoglobulin and/or nucleos(t)ide analogues for prophylaxis against hepatitis b virus recurrence after liver transplantation: a systematic review. Liver Transpl. 2011 Oct;17(10):1176-90. doi: 10.1002/lt.22354. Review.
•   Chu CM, Karayiannis P, Fowler MJ, Monjardino J, Liaw YF, Thomas HC
  Natural history of chronic hepatitis B virus infection in Taiwan: studies of hepatitis B virus DNA in serum. Hepatology. 1985 May-Jun;5(3):431-4.
•   Das A, Maini MK
  Innate and adaptive immune responses in hepatitis B virus infection. Dig Dis. 2010;28(1):126-32. doi: 10.1159/000282075. Epub 2010 May 7. Review.
•   Di Paolo D, Lenci I, Cerocchi C, Tariciotti L, Monaco A, Brega A, Lotti L, Tisone G, Angelico M
  One-year vaccination against hepatitis B virus with a MPL-vaccine in liver transplant patients for HBV-related cirrhosis. Transpl Int. 2010 Nov;23(11):1105-12. doi: 10.1111/j.1432-2277.2010.01104.x. Epub 2010 Aug 19.
•   Di Paolo D, Lenci I, Trinito MO, Carbone M, Longhi C, Tisone G, Angelico M
  Extended double-dosage HBV vaccination after liver transplantation is ineffective, in the absence of lamivudine and prior wash-out of human Hepatitis B immunoglobulins. Dig Liver Dis. 2006 Oct;38(10):749-54. Epub 2006 Aug 17.
•   El Khouri M, dos Santos VA
  Hepatitis B: epidemiological, immunological, and serological considerations emphasizing mutation. Rev Hosp Clin Fac Med Sao Paulo. 2004 Aug;59(4):216-24. Epub 2004 Sep 9. Review.
•   European Association For The Study Of The Liver
  EASL Clinical Practice Guidelines: management of chronic hepatitis B. J Hepatol. 2009 Feb;50(2):227-42. doi: 10.1016/j.jhep.2008.10.001. Epub 2008 Oct 29. Review.
•   Fisicaro P, Valdatta C, Boni C, Massari M, Mori C, Zerbini A, Orlandini A, Sacchelli L, Missale G, Ferrari C
  Early kinetics of innate and adaptive immune responses during hepatitis B virus infection. Gut. 2009 Jul;58(7):974-82. doi: 10.1136/gut.2008.163600. Epub 2009 Feb 6.
•   Freitas N, Cunha C, Menne S, Gudima SO
  Envelope proteins derived from naturally integrated hepatitis B virus DNA support assembly and release of infectious hepatitis delta virus particles. J Virol. 2014 May;88(10):5742-54. doi: 10.1128/JVI.00430-14. Epub 2014 Mar 12.
•   Godon O, Fontaine H, Kahi S, Meritet JF, Scott-Algara D, Pol S, Michel ML, Bourgine M; ANRS HB02 study group
  Immunological and antiviral responses after therapeutic DNA immunization in chronic hepatitis B patients efficiently treated by analogues. Mol Ther. 2014 Mar;22(3):675-684. doi: 10.1038/mt.2013.274. Epub 2013 Dec 5.
•   Hoa PT, Huy NT, Thu le T, Nga CN, Nakao K, Eguchi K, Chi NH, Hoang BH, Hirayama K
  Randomized controlled study investigating viral suppression and serological response following pre-S1/pre-S2/S vaccine therapy combined with lamivudine treatment in HBeAg-positive patients with chronic hepatitis B. Antimicrob Agents Chemother. 2009 Dec;53(12):5134-40. doi: 10.1128/AAC.00276-09. Epub 2009 Sep 21.
•   Jeng WJ, Sheen IS, Chen YC, Hsu CW, Chien RN, Chu CM, Liaw YF
  Off-therapy durability of response to entecavir therapy in hepatitis B e antigen-negative chronic hepatitis B patients. Hepatology. 2013 Dec;58(6):1888-96. doi: 10.1002/hep.26549. Epub 2013 Oct 17.
•   Kamatani Y, Wattanapokayakit S, Ochi H, Kawaguchi T, Takahashi A, Hosono N, Kubo M, Tsunoda T, Kamatani N, Kumada H, Puseenam A, Sura T, Daigo Y, Chayama K, Chantratita W, Nakamura Y, Matsuda K
  A genome-wide association study identifies variants in the HLA-DP locus associated with chronic hepatitis B in Asians. Nat Genet. 2009 May;41(5):591-5. doi: 10.1038/ng.348. Epub 2009 Apr 6.
•   Karasu Z, Ozacar T, Akarca U, Ersoz G, Erensoy S, Gunsar F, Kobat A, Tokat Y, Batur Y
  HBV vaccination in liver transplant recipients: not an effective strategy in the prophylaxis of HBV recurrence. J Viral Hepat. 2005 Mar;12(2):212-5.
•   Kennedy PTF, Sandalova E, Jo J, Gill U, Ushiro-Lumb I, Tan AT, Naik S, Foster GR, Bertoletti A
  Preserved T-cell function in children and young adults with immune-tolerant chronic hepatitis B. Gastroenterology. 2012 Sep;143(3):637-645. doi: 10.1053/j.gastro.2012.06.009. Epub 2012 Jun 15.
•   Kim YJ, Kim K, Hwang SH, Kim SS, Lee D, Cheong JY, Cho SW
  Durability after discontinuation of nucleos(t)ide therapy in chronic HBeAg negative hepatitis patients. Clin Mol Hepatol. 2013 Sep;19(3):300-4. doi: 10.3350/cmh.2013.19.3.300. Epub 2013 Sep 30.
•   Koay LB, Feng IC, Sheu MJ, Kuo HT, Lin CY, Chen JJ, Wang SL, Tang LY, Tsai SL
  Hepatitis B virus (HBV) core antigen-specific regulatory T cells confer sustained remission to anti-HBV therapy in chronic hepatitis B with acute exacerbation. Hum Immunol. 2011 Sep;72(9):687-98. doi: 10.1016/j.humimm.2010.11.001. Epub 2011 Jan 6.
•   Kondo Y, Kobayashi K, Asabe S, Shiina M, Niitsuma H, Ueno Y, Kobayashi T, Shimosegawa T
  Vigorous response of cytotoxic T lymphocytes associated with systemic activation of CD8 T lymphocytes in fulminant hepatitis B. Liver Int. 2004 Dec;24(6):561-7.
•   Kondo Y, Ueno Y, Kobayashi K, Kakazu E, Shiina M, Inoue J, Tamai K, Wakui Y, Tanaka Y, Ninomiya M, Obara N, Fukushima K, Ishii M, Kobayashi T, Niitsuma H, Kon S, Shimosegawa T
  Hepatitis B virus replication could enhance regulatory T cell activity by producing soluble heat shock protein 60 from hepatocytes. J Infect Dis. 2010 Jul 15;202(2):202-13. doi: 10.1086/653496.
•   Kosinska AD, Zhang E, Johrden L, Liu J, Seiz PL, Zhang X, Ma Z, Kemper T, Fiedler M, Glebe D, Wildner O, Dittmer U, Lu M, Roggendorf M
  Combination of DNA prime--adenovirus boost immunization with entecavir elicits sustained control of chronic hepatitis B in the woodchuck model. PLoS Pathog. 2013;9(6):e1003391. doi: 10.1371/journal.ppat.1003391. Epub 2013 Jun 13.
•   Levrero M, Pollicino T, Petersen J, Belloni L, Raimondo G, Dandri M
  Control of cccDNA function in hepatitis B virus infection. J Hepatol. 2009 Sep;51(3):581-92. doi: 10.1016/j.jhep.2009.05.022. Epub 2009 Jun 10. Review.
•   Li J, Qiu SJ, She WM, Wang FP, Gao H, Li L, Tu CT, Wang JY, Shen XZ, Jiang W
  Significance of the balance between regulatory T (Treg) and T helper 17 (Th17) cells during hepatitis B virus related liver fibrosis. PLoS One. 2012;7(6):e39307. doi: 10.1371/journal.pone.0039307. Epub 2012 Jun 20.
•   Liaw YF, Brunetto MR, Hadziyannis S
  The natural history of chronic HBV infection and geographical differences. Antivir Ther. 2010;15 Suppl 3:25-33. doi: 10.3851/IMP1621. Review.
•   Liaw YF, Jia JD, Chan HL, Han KH, Tanwandee T, Chuang WL, Tan DM, Chen XY, Gane E, Piratvisuth T, Chen L, Xie Q, Sung JJ, Wat C, Bernaards C, Cui Y, Marcellin P
  Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C. Hepatology. 2011 Nov;54(5):1591-9. doi: 10.1002/hep.24555.
•   Liaw YF, Leung N, Kao JH, Piratvisuth T, Gane E, Han KH, Guan R, Lau GK, Locarnini S; Chronic Hepatitis B Guideline Working Party of the Asian-Pacific Association for the Study of the Liver
  Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int. 2008 Sep;2(3):263-83. doi: 10.1007/s12072-008-9080-3. Epub 2008 May 10.
•   Liaw YF, Tai DI, Chen TJ, Chu CM, Huang MJ
  Alpha-fetoprotein changes in the course of chronic hepatitis: relation to bridging hepatic necrosis and hepatocellular carcinoma. Liver. 1986 Jun;6(3):133-7.
•   Liaw YF, Tai DI, Chu CM, Chen TJ
  The development of cirrhosis in patients with chronic type B hepatitis: a prospective study. Hepatology. 1988 May-Jun;8(3):493-6.
•   Liaw YF, Tai DI, Chu CM, Lin DY, Sheen IS, Chen TJ, Pao CC
  Early detection of hepatocellular carcinoma in patients with chronic type B hepatitis. A prospective study. Gastroenterology. 1986 Feb;90(2):263-7.
•   Liaw YF
  Natural history of chronic hepatitis B virus infection and long-term outcome under treatment. Liver Int. 2009 Jan;29 Suppl 1:100-7. doi: 10.1111/j.1478-3231.2008.01941.x. Review.
•   Lo CM, Lau GK, Chan SC, Fan ST, Wong J
  Efficacy of a pre-S containing vaccine in patients receiving lamivudine prophylaxis after liver transplantation for chronic hepatitis B. Am J Transplant. 2007 Feb;7(2):434-9.
•   Lo CM, Liu CL, Chan SC, Lau GK, Fan ST
  Failure of hepatitis B vaccination in patients receiving lamivudine prophylaxis after liver transplantation for chronic hepatitis B. J Hepatol. 2005 Aug;43(2):283-7.
•   Lok AS, McMahon BJ
  Chronic hepatitis B: update 2009. Hepatology. 2009 Sep;50(3):661-2. doi: 10.1002/hep.23190.
•   Marcellin P, Bonino F, Lau GK, Farci P, Yurdaydin C, Piratvisuth T, Jin R, Gurel S, Lu ZM, Wu J, Popescu M, Hadziyannis S; Peginterferon alfa-2a in HBeAg-negative Chronic Hepatitis B Study Group
  Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alpha-2a. Gastroenterology. 2009 Jun;136(7):2169-2179.e1-4. doi: 10.1053/j.gastro.2009.03.006. Epub 2009 Mar 19.
•   Marinos G, Naoumov NV, Williams R
  Impact of complete inhibition of viral replication on the cellular immune response in chronic hepatitis B virus infection. Hepatology. 1996 Nov;24(5):991-5.
•   Mbarek H, Ochi H, Urabe Y, Kumar V, Kubo M, Hosono N, Takahashi A, Kamatani Y, Miki D, Abe H, Tsunoda T, Kamatani N, Chayama K, Nakamura Y, Matsuda K
  A genome-wide association study of chronic hepatitis B identified novel risk locus in a Japanese population. Hum Mol Genet. 2011 Oct 1;20(19):3884-92. doi: 10.1093/hmg/ddr301. Epub 2011 Jul 12.
•   McDermott AB, Cohen SB, Zuckerman JN, Madrigal JA
  Hepatitis B third-generation vaccines: improved response and conventional vaccine non-response--evidence for genetic basis in humans. J Viral Hepat. 1998 Nov;5 Suppl 2:9-11.
•   Peng G, Li S, Wu W, Sun Z, Chen Y, Chen Z
  Circulating CD4+ CD25+ regulatory T cells correlate with chronic hepatitis B infection. Immunology. 2008 Jan;123(1):57-65. Epub 2007 Aug 31.
•   Pontesilli O, van Nunen AB, van Riel D, Carotenuto P, Niesters HG, Uytdehaag FG, De Man RA, Osterhaus AD
  Hepatitis B virus-specific T cell response in chronic hepatitis B patients treated with lamivudine and interferon-alpha. Liver Int. 2004 Aug;24(4):308-15.
•   Raz R, Koren R, Bass D
  Safety and immunogenicity of a new mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in adults. Isr Med Assoc J. 2001 May;3(5):328-32.
•   Reijnders JG, Perquin MJ, Zhang N, Hansen BE, Janssen HL
  Nucleos(t)ide analogues only induce temporary hepatitis B e antigen seroconversion in most patients with chronic hepatitis B. Gastroenterology. 2010 Aug;139(2):491-8. doi: 10.1053/j.gastro.2010.03.059. Epub 2010 Apr 8.
•   Sobao Y, Tomiyama H, Sugi K, Tokunaga M, Ueno T, Saito S, Fujiyama S, Morimoto M, Tanaka K, Takiguchi M
  The role of hepatitis B virus-specific memory CD8 T cells in the control of viral replication. J Hepatol. 2002 Jan;36(1):105-15.
•   Tai DI, Lin SM, Sheen IS, Chu CM, Lin DY, Liaw YF
  Long-term outcome of hepatitis B e antigen-negative hepatitis B surface antigen carriers in relation to changes of alanine aminotransferase levels over time. Hepatology. 2009 Jun;49(6):1859-67. doi: 10.1002/hep.22878.
•   Tan AT, Koh S, Goh W, Zhe HY, Gehring AJ, Lim SG, Bertoletti A
  A longitudinal analysis of innate and adaptive immune profile during hepatic flares in chronic hepatitis B. J Hepatol. 2010 Mar;52(3):330-9. doi: 10.1016/j.jhep.2009.12.015. Epub 2010 Jan 13.
•   Tjwa ET, van Oord GW, Hegmans JP, Janssen HL, Woltman AM
  Viral load reduction improves activation and function of natural killer cells in patients with chronic hepatitis B. J Hepatol. 2011 Feb;54(2):209-18. doi: 10.1016/j.jhep.2010.07.009. Epub 2010 Sep 6.
•   Tsay PK, Tai DI, Chen YM, Yu CP, Wan SY, Shen YJ, Lin DY
  Impact of gender, viral transmission and aging in the prevalence of hepatitis B surface antigen. Chang Gung Med J. 2009 Mar-Apr;32(2):155-64.
•   Wang HC, Wu HC, Chen CF, Fausto N, Lei HY, Su IJ
  Different types of ground glass hepatocytes in chronic hepatitis B virus infection contain specific pre-S mutants that may induce endoplasmic reticulum stress. Am J Pathol. 2003 Dec;163(6):2441-9.
•   Xu L, Yin W, Sun R, Wei H, Tian Z
  Liver type I regulatory T cells suppress germinal center formation in HBV-tolerant mice. Proc Natl Acad Sci U S A. 2013 Oct 15;110(42):16993-8. doi: 10.1073/pnas.1306437110. Epub 2013 Oct 2.
•   Yang D, Liu L, Zhu D, Peng H, Su L, Fu YX, Zhang L
  A mouse model for HBV immunotolerance and immunotherapy. Cell Mol Immunol. 2014 Jan;11(1):71-8. doi: 10.1038/cmi.2013.43. Epub 2013 Sep 30.
•   Yu XP, Guo RY, Su ML, Ming DS, Lin CZ, Deng Y, Lin ZZ, Su ZJ
  Dynamic Changes of Treg and Th17 Cells and Related Cytokines Closely Correlate With the Virological and Biochemical Response in Chronic Hepatitis B Patients Undergoing Nucleos(t)ide Analogues Treatment. Hepat Mon. 2013 Dec 23;13(12):e15332. doi: 10.5812/hepatmon.15332. eCollection 2013.
•   Zoulim F, Durantel D, Deny P
  Management and prevention of drug resistance in chronic hepatitis B. Liver Int. 2009 Jan;29 Suppl 1:108-15. doi: 10.1111/j.1478-3231.2008.01939.x. Review.

Efficacy of HBV Therapeutic Vaccine in Consolidation of Nucleos(t)Ide Analogues Therapy: a Pilot Study

Details for clinical trial NCT02505009