New Vaccine against Hepatitis B on Clinical Studies in Cuba

StephenW

New Vaccine against Hepatitis B on Clinical Studies in Cuba

Friday, 02 March 2012 11:41

Havana, Cuba, Mar 2.- A new Cuban vaccine against chronic Hepatitis B (Nasvac) will be one of the innovations to be introduced during the upcoming International Congress on Biotechnology scheduled for March 5-8 in Havana. Dr. Gerardo Guillen Nieto, vice president of the event’s organizing committee, told reporters that good results have been obtained during the almost finished clinical studies of this vaccine, which is unique in the world. Guillen Nieto, head of Biomedical Research at the Havana-based Center of Genetic Engineering and Biotechnology (CIGB), said the results obtained during clinical studies of the vaccine in Cuba and Bangladesh are far superior than any others involving the treatment of Hepatitis B. More than 600 specialists from almost 40 countries will participate in the International Congress on Biotechnology. The list of guests includes American biologist Peter Agre, the 2003 Nobel Prize in Chemistry and professor at the Johns Hopkins University, who will give a lecture on biochemical and biotechnological advances and their impact on the treatment of malaria. During the event, Cuban specialists will also introduce the results of clinical trials of another therapeutic vaccine against Hepatitis C developed in the Caribbean nation. Also scheduled are three symposiums on the research and development of products and vaccines against cancer, dengue, AIDS, and Hepatitis B and C, among other diseases. More than 70 foreign and 30 Cuban lecturers will speak about the topics that include pre-clinical trials of a vaccine candidate against HIV/AIDS, whose first phase of clinical trials should begin this year, according to Guillen Nieto. (ACN)

StephenW

新疫苗对B型肝炎的临床研究对古巴的PDF打印E-mail
2012年3月02日（星期五）11:41

3月2日，古巴哈瓦那 - 一种新的疫苗对慢性乙型肝炎（Nasvac）古巴将要在即将举行的国际大会介绍了三月5-8预定在哈瓦那生物技术的创新之一。

活动的组委会副总裁，赫拉尔多·吉兰涅托，博士告诉记者，在这种疫苗，这在世界上是独一无二的，几乎完成的临床研究获得了良好的效果。

吉兰涅托在哈瓦那遗传工程和生物技术（CIGB）为基础的中心，生物医学研究的负责人说，在古巴和孟加拉国的疫苗的临床研究期间所取得的成果远远超过其他任何涉及B型肝炎的治疗优越

来自近40个国家的600多名专家将参加国际大会
生物技术。嘉宾的名单包括美国生物学家彼得·阿格雷，在约翰霍普金斯大学2003年诺贝尔化学教授奖，会给生化和生物技术的进步和他们对治疗疟疾的影响发表演讲。

古巴专家在活动期间，还将推出加勒比国家开发另一对丙型肝炎的治疗疫苗临床试验的结果。

还安排其他疾病之间的对抗癌症，登革热，艾滋病，乙型肝炎和丙型肝炎，产品和疫苗的研究和发展三个专题讨论会。

70多名外国和30古巴讲师将谈论的主题，包括了对艾滋病毒/艾滋病，其第一阶段的临床试验应在今年开始的候选疫苗的临床前试验，根据吉兰涅托。 （亚太）

StephenW

    NASVAC Phase-III Trial in Chronic Hepatitis B (CHB) Patients
                         This study is currently recruiting participants.   
                              Verified June 2011 by Clinical Research Organization, Dhaka, Bangladesh   
            
      First Received on June 12, 2011.            Last Updated on June 14, 2011        History of Changes      
  

Sponsor:	Clinical Research Organization, Dhaka, Bangladesh
Information provided by:	Clinical Research Organization, Dhaka, Bangladesh
ClinicalTrials.gov Identifier:	NCT01374308

    Purpose  

The general objective of the present clinical trial is to compare the therapeutic efficacy of a combination therapeutic vaccine containing hepatitis B surface antigen (HBsAg) and hepatitis B core antigen (HBcAg) [later called NASVAC] with a commonly used antiviral drug, pegylated interferon in patients with chronic hepatitis B (CHB).

      

  

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: HBsAg and HBcAg combination                 Drug: Peginterferon alfa-2b	Phase III

  

  
      

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase IIII Study of a Therapeutic Vaccine Candidate Containing Hepatitis B Virus (HBV) Core Antigen (HBcAg) and HBV Surface Antigen (HBsAg) for Treatment of Patients With Chronic HBV Infection

      
  Resource links provided by NLM:
  
              MedlinePlus related topics:            Hepatitis                Hepatitis A                Hepatitis B         
            Drug Information available for:            Peginterferon Alfa-2b                Interferons         
    U.S. FDA Resources   
   
        
  Further study details as provided by Clinical Research Organization, Dhaka, Bangladesh:
  
              Primary Outcome Measures:      

• Number of study participants with virological and or biochemical response as a measure of efficacy [ Time Frame: At week 96 ] [ Designated as safety issue: Yes ]
  
  

   
   
               

Estimated  Enrollment:	160
Study Start Date:	June 2011
Estimated  Study Completion Date:	June 2013
Estimated  Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

            

   

Arms	Assigned Interventions
Active Comparator: Pegylated Interferon 2b	Drug: Peginterferon alfa-2bPegylated Interferon 2b will be administered at weekly intervals at 100 micro gms dose subcutaneously for 48 weeks Other Name: Pegintron
Active Comparator: HBsAg and HBcAg combination	Drug: HBsAg and HBcAg combinationHBsAg and HBcAg combination applied at a dose of 100 micro gms. intra-nasally at 2 weekly intervals for 5 times followed by 100 micro gms. intra-nasally plus 100 micro gms. subcutaneously at 2 weekly intervals for another 5 times Other Name: NASVAC

   

   
                                Detailed Description:   

To collect and assess data on the therapeutic potential of the NASVAC in CHB patients regarding:

Reduction of the serum HBV DNA levels. Reduction in the levels of alanine aminotransferase (ALT) Clearance of hepatitis B e antigen (HBeAg) Negativation or lowering of HBsAg Anti-HBsAg/anti-HBeAg seroconversion

An additional objective of this study is to reconfirm the safety of NASVAC in CHB patients that has previously been shown by us in Phase I-II clinical trial in CHB patients.

         
  

   

cwy121

楼主，能不能介绍的具体些，这个疫苗是只具有预防作用啊，还是有治疗作用的~

StephenW

回复 cwy121 的帖子

治疗, HbsAg + HBcAg, 第3阶段.

cwy121

回复 StephenW 的帖子

我知道古巴的医疗技术水平在世界上是相当先进的，去年他们研制出了一种治疗某型肺癌的疫苗，效果相当不错，并且已经上市，我相信古巴的这款药物会有很好的疗效~继续关注~~~

cwy121

楼主把这个帖子置顶吧~

无敌抗体

古巴那么牛？才研制了肺癌疫苗，现在又出这个？

cwy121

回复 无敌抗体 的帖子

古巴的医学水平在世界上的地位不亚于美欧发达国家。他们的脑科，免疫科学，眼科一直是世界上比较先进的~中国和古巴在脑科，眼科医疗领域有长期合作。中古在河南合作建设了一座眼科医院~

sunpk861007

回复 StephenW 的帖子

楼主太棒了，感谢你提供的信息，给战友们带来很大的希望，希望继续关注，感谢