Al-Mahtab Mamun, Akbar Sheikh Mohammad Fazle, Aguilar Julio Cesar, Uddin Md Helal, Khan Md Sakirul Islam, Rahman Salimur
Department of Hepatology, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Department of Medical Sciences, Toshiba General Hospital, Higashi Oi 6-3-22, Tokyo, 140-8522, Japan.
Hepatol Int. 2013 Oct;7(4):981-9. doi: 10.1007/s12072-013-9486-4. Epub 2013 Nov 9.
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).
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.
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.
HBsAg/HBcAg vaccine seems a safe and efficient therapeutic approach for patients with CHB.
评估一种同时包含乙肝表面抗原（HBsAg）和乙肝核心抗原（HBcAg）（HBsAg/HBcAg）的疫苗在慢性乙型肝炎（CHB）患者中的安全性和临床疗效。
18例CHB患者接种了含100μg HBsAg和100μg HBcAg的疫苗。疫苗每隔2周接种1次，共接种10次，前5次仅通过鼻腔途径接种，后5次通过鼻腔和皮下途径接种。通过在治疗期间以及治疗后24周和48周定期评估患者的一般状况、病毒动力学和生化参数，来评估这种治疗方法的安全性和疗效。评估外周血单核细胞（PBMC）和抗原脉冲树突状细胞（DC）产生细胞因子的情况，以评估HBsAg/HBcAg疫苗对CHB患者的免疫调节作用。
HBsAg/HBcAg疫苗在所有患者中均安全。所有患者均未出现乙肝病毒DNA（HBV DNA）或丙氨酸转氨酶（ALT）的 flare。分别在9例（50%）CHB患者中检测到持续的HBV DNA阴性，18例（100%）患者的ALT持续正常。体外经HBsAg/HBcAg刺激后，接种HBsAg/HBcAg疫苗的CHB患者的PBMC和HBsAg/HBcAg脉冲DC产生的多种细胞因子[白细胞介素1β（IL-1β）、IL-6、IL-8、IL-12和肿瘤坏死因子α（TNF-α）]水平显著高于未接种疫苗的对照CHB患者（p<0.05）。
HBsAg/HBcAg疫苗似乎是CHB患者一种安全有效的治疗方法。
