Mamun Al-Mahtab1, Sheikh Mohammad Fazle Akbar2, Julio Cesar Aguilar3, Md Helal Uddin4, Md Sakirul Islam Khan5, Salimur Rahman6. 1. Department of Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. shwapnil@agni.com. 2. Department of Medical Sciences, Toshiba General Hospital, Higashi Oi 6-3-22, Tokyo, 140-8522, Japan. sheikh.akbar@po.toshiba.co.jp. 3. Center for Genetic Engineering and Biotechnology, Havana, Cuba. julio.aguilar@cigb.edu.cu. 4. Clinical Research Organization, Dhaka, Bangladesh. uddinhelal1970@gmail.com. 5. Bangladesh Agricultural University, Mymensign, Bangladesh. sakirul.khan@gmail.com. 6. Department of Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. salimur51@yahoo.com.
Abstract
PURPOSE: The safety and clinical efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (HBsAg/HBcAg) were evaluated in patients with chronic hepatitis B (CHB). METHODS: Eighteen patients with CHB were administered a vaccine containing 100 μg of HBsAg and 100 μg of HBcAg. The vaccine was administered ten times at 2-weekly intervals, the first five times via the nasal route only and the subsequent five times via both nasal and subcutaneous routes. The safety and efficacy of this therapeutic approach were assessed by periodic assessment of the patients' general condition, viral kinetics, and biochemical parameters during treatment and 24 and 48 weeks after therapy. The production of cytokines by peripheral blood mononuclear cells (PBMC) and antigen-pulsed dendritic cells (DC) was evaluated to assess the immunomodulatory effects of the HBsAg/HBcAg vaccine in CHB patients. RESULTS: The HBsAg/HBcAg vaccine was safe in all patients. No flare of HBV DNA or alanine aminotransferase (ALT) was recorded in any patient. Sustained HBV DNA negativity and persistently normalized ALT were detected in 9 (50 %) and 18 (100 %) patients with CHB, respectively. PBMC and HBsAg/HBcAg-pulsed DCs from HBsAg/HBcAg-vaccinated CHB patients produced significantly higher levels of various cytokines [interleukin 1β (IL-1β), IL-6, IL-8, IL-12, and tumor necrosis factor α (TNF-α)] than those from control unvaccinated CHB patients (p < 0.05) after stimulation with HBsAg/HBcAg in vitro. CONCLUSION: HBsAg/HBcAg vaccine seems a safe and efficient therapeutic approach for patients with CHB.
PURPOSE: The safety and clinical efficacy of a vaccine containing both hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) (HBsAg/HBcAg) were evaluated in patients with chronic hepatitis B (CHB). METHODS: Eighteen patients with CHB were administered a vaccine containing 100 μg of HBsAg and 100 μg of HBcAg. The vaccine was administered ten times at 2-weekly intervals, the first five times via the nasal route only and the subsequent five times via both nasal and subcutaneous routes. The safety and efficacy of this therapeutic approach were assessed by periodic assessment of the patients' general condition, viral kinetics, and biochemical parameters during treatment and 24 and 48 weeks after therapy. The production of cytokines by peripheral blood mononuclear cells (PBMC) and antigen-pulsed dendritic cells (DC) was evaluated to assess the immunomodulatory effects of the HBsAg/HBcAg vaccine in CHB patients. RESULTS: The HBsAg/HBcAg vaccine was safe in all patients. No flare of HBV DNA or alanine aminotransferase (ALT) was recorded in any patient. Sustained HBV DNA negativity and persistently normalized ALT were detected in 9 (50 %) and 18 (100 %) patients with CHB, respectively. PBMC and HBsAg/HBcAg-pulsed DCs from HBsAg/HBcAg-vaccinated CHB patients produced significantly higher levels of various cytokines [interleukin 1β (IL-1β), IL-6, IL-8, IL-12, and tumor necrosis factor α (TNF-α)] than those from control unvaccinated CHB patients (p < 0.05) after stimulation with HBsAg/HBcAg in vitro. CONCLUSION: HBsAg/HBcAg vaccine seems a safe and efficient therapeutic approach for patients with CHB.
Authors: Pierre Vandepapelière; George K K Lau; Geert Leroux-Roels; Yves Horsmans; Edward Gane; Tawesak Tawandee; Mohd Ismail bin Merican; Khin Maung Win; Christian Trepo; Graham Cooksley; Martine Wettendorff; Carlo Ferrari Journal: Vaccine Date: 2007-10-24 Impact factor: 3.641
Authors: Stephanos J Hadziyannis; Nicolaos C Tassopoulos; E Jenny Heathcote; Ting-Tsung Chang; George Kitis; Mario Rizzetto; Patrick Marcellin; Seng Gee Lim; Zachary Goodman; Michael S Wulfsohn; Shelly Xiong; John Fry; Carol L Brosgart Journal: N Engl J Med Date: 2003-02-27 Impact factor: 91.245
Authors: M K Maini; C Boni; C K Lee; J R Larrubia; S Reignat; G S Ogg; A S King; J Herberg; R Gilson; A Alisa; R Williams; D Vergani; N V Naoumov; C Ferrari; A Bertoletti Journal: J Exp Med Date: 2000-04-17 Impact factor: 14.307