深病毒抑制序贯免疫调节（鸡尾酒疗法）的整合，恢复抗病

StephenW

Also this:
http://clinicaltrials.gov/show/NCT01878565

The Treatment With HBIG+GM-CSF+HBV Vaccine for Chronic Hepatitis B Patients With HBeAg Seroconversion
This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Beijing 302 Hospital
Sponsor:
Beijing 302 Hospital
Information provided by (Responsible Party):
Fu-Sheng Wang, Beijing 302 Hospital
ClinicalTrials.gov Identifier:
NCT01878565
First received: June 12, 2013
Last updated: July 23, 2013
Last verified: July 2013

  Purpose

The host immunity has been generally recognized as the main factors to determine the outcome of chronic hepatitis B virus (HBV) infection; however, previous studies have shown that HBV-specific T cell and B cell function are exhausted in chronic hepatitis B (CHB) patients. Recently, It is suggested that hepatitis B surface antigen (HBsAg) may play a key role in the immune tolerance or immune exhaustion. Anti-HBV immune responses are partially recovered when patients achieved hepatitis B e antigen (HBeAg) seroconversion during antiviral therapy, and can be nearly recovered during HBsAg seroconversion. However, it is still difficult to achieve the ideal terminal, HBsAg seroconversion. For this reason, immunotherapy would be helpful to enhance the anti-HBV immunity and acquire higher HBsAg seroconversion. Here, the investigators propose a hypothesis that hepatitis B immune globin (HBIG)+granulocyte-macrophage colony-stimulating factor (GM-CSF)+HBV vaccine can enhance anti-HBV immune responses and improve HBsAg seroconversion in CHB patients who has achieved HBeAg seroconversion using nucleoside analogues treatment.
Experimental: Drug treatment
Drug: Given four times in week 0, 4, 12 and 24. At each time of treatment, the patients will be hospitalized and treated with 800 unit of HBIG intramuscularly at day 0, 1, 2, 3 and 4, then were treated with 75 μg of GM-CSF subcutaneously at day 2, 3, 4, 5 and 6, and finally were injected 20μg of HBV vaccine subcutaneously at day 6.

GM-CSF control
GM-CSF was given four times as control in week 0, 4, 12 and 24. At each time of treatment, the patients will be hospitalized and treated with GM-CSF intramuscularly or subcutaneously at day 2, 3, 4, 5, 6.

同时这的：

治疗用乙肝免疫球蛋白+ GM-CSF+乙肝疫苗治疗慢性乙型肝炎患者HBeAg血清转换
这项研究目前正在招募参与者。 （见联系方式和地点）
证实2013年7月由北京302医院
主办单位：
北京302医院
由（责任方）提供的信息：
王福生，北京302医院
ClinicalTrials.gov标识符：
NCT01878565
第一次收到：2013年6月12日
最后更新：2013年7月23日
最后证实：2013年7月

  目的

宿主免疫已被公认为是主要的因素来确定的慢性乙型肝炎病毒（HBV）感染的结果;然而，先前的研究已经表明，HBV特异性T细胞和B细胞的功能被耗尽在慢性乙型肝炎（CHB）的患者。最近，有人建议，乙肝表面抗原（HBsAg），也可以在免疫耐受或免疫耗竭起到关键的作用。抗HBV免疫反应部分恢复，当患者在抗病毒治疗实现乙肝e抗原（HBeAg）血清学转换，并且可以在乙肝表面抗原血清学转换几乎被收回。然而，它仍然是难以达到理想的终端，HBsAg的血清转换。出于这个原因，免疫疗法将是有益的，以提高抗HBV免疫和获得更高的HBsAg血清转换。在这里，研究人员提出了一个假设，即乙肝免疫球蛋白（HBIG）+粒细胞 - 巨噬细胞集落刺激因子（GM-CSF）+乙肝疫苗能增强抗HBV免疫应答，提高乙肝表面抗原血清学转换在慢性乙肝患者谁取得了HBeAg血清转换使用核苷类似物治疗。
实验：药物治疗
药物：由于在第0周，第4，第12和244倍。在治疗的每一次中，将患者住院并用800单位球蛋白的肌肉内，在0天，1个，2个，3个和4个处理，然后分别与处理75 GM-CSF的皮下注射微克在第2天，3，4，5和6，最后注射的乙肝疫苗皮下注射20μg的第6天。

GM-CSF控制
GM-CSF给予四倍控制在0周，第4，第12和24.在治疗的每一次中，将患者住院，并与GM-CSF的肌内注射或皮下注射在第2天，3个，4个，5个，6个处理。