Hepatitis B Vaccine for Non-responders

Summary

In the current study, the investigators study the efficacy of the HBAI20 vaccine to induce seroprotection in registered non-responders (adults who were previously vaccinated with the HBVaxPro-10μg but did not achieve seroprotection). The study will further assess the safety of the HBAI20 vaccine in comparison with HBVaxPro-10μg.

Timeline

Start

2017-10-11

Primary completion

2019-01-09

Completion

2019-01-09

Publications

• Background Coates T, Wilson R, Patrick G, Andre F, Watson V. Hepatitis B vaccines: assessment of the seroprotective efficacy of two recombinant DNA vaccines. Clin Ther. 2001 Mar;23(3):392-403. doi: 10.1016/s0149-2918(01)80044-8.
• Background Jack AD, Hall AJ, Maine N, Mendy M, Whittle HC. What level of hepatitis B antibody is protective? J Infect Dis. 1999 Feb;179(2):489-92. doi: 10.1086/314578.
• Background Yu AS, Cheung RC, Keeffe EB. Hepatitis B vaccines. Infect Dis Clin North Am. 2006 Mar;20(1):27-45. doi: 10.1016/j.idc.2006.01.004.
• Background Cardell K, Akerlind B, Sallberg M, Fryden A. Excellent response rate to a double dose of the combined hepatitis A and B vaccine in previous nonresponders to hepatitis B vaccine. J Infect Dis. 2008 Aug 1;198(3):299-304. doi: 10.1086/589722.
• Background Halperin SA, Dobson S, McNeil S, Langley JM, Smith B, McCall-Sani R, Levitt D, Nest GV, Gennevois D, Eiden JJ. Comparison of the safety and immunogenicity of hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide and a licensed hepatitis B vaccine in healthy young adults. Vaccine. 2006 Jan 9;24(1):20-6. doi: 10.1016/j.vaccine.2005.08.095. Epub 2005 Sep 12.
• Background Halperin SA, Ward BJ, Dionne M, Langley JM, McNeil SA, Smith B, Mackinnon-Cameron D, Heyward WL, Martin JT. Immunogenicity of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in nonresponders to licensed hepatitis B vaccine. Hum Vaccin Immunother. 2013 Jul;9(7):1438-44. doi: 10.4161/hv.24256. Epub 2013 Apr 9.
• Background Ambrosch F, Wiedermann G, Kundi M, Leroux-Roels G, Desombere I, Garcon N, Thiriart C, Slaoui M, Thoelen S. A hepatitis B vaccine formulated with a novel adjuvant system. Vaccine. 2000 Apr 14;18(20):2095-101. doi: 10.1016/s0264-410x(99)00566-6.
• Background Levie K, Gjorup I, Skinhoj P, Stoffel M. A 2-dose regimen of a recombinant hepatitis B vaccine with the immune stimulant AS04 compared with the standard 3-dose regimen of Engerix-B in healthy young adults. Scand J Infect Dis. 2002;34(8):610-4. doi: 10.1080/00365540110080881.
• Background Desombere I, Van der Wielen M, Van Damme P, Stoffel M, De Clercq N, Goilav C, Leroux-Roels G. Immune response of HLA DQ2 positive subjects, vaccinated with HBsAg/AS04, a hepatitis B vaccine with a novel adjuvant. Vaccine. 2002 Jun 7;20(19-20):2597-602. doi: 10.1016/s0264-410x(02)00150-0.
• Background Jacques P, Moens G, Desombere I, Dewijngaert J, Leroux-Roels G, Wettendorff M, Thoelen S. The immunogenicity and reactogenicity profile of a candidate hepatitis B vaccine in an adult vaccine non-responder population. Vaccine. 2002 Nov 1;20(31-32):3644-9. doi: 10.1016/s0264-410x(02)00397-3.
• Background Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
• Background Siegel JP, Puri RK. Interleukin-2 toxicity. J Clin Oncol. 1991 Apr;9(4):694-704. doi: 10.1200/JCO.1991.9.4.694.
• Background Vial T, Descotes J. Clinical toxicity of interleukin-2. Drug Saf. 1992 Nov-Dec;7(6):417-33. doi: 10.2165/00002018-199207060-00004.

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