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. |
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 |
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 |
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 |
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 |
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.
8 :50 | 9 :10 | Mamun-Al-Mahtab | Clinical experience with NASVAC in Bangladeshi patients | Bangladesh |
Cuba to Exhibit Progress in Therapeutic Vaccine against Hepatitis B |
Havana, Mar 8 (Prensa Latina) Cuban experts are working on a vaccine candidate against hepatitis B, which encouraging results in clinical trials will be presented on Thursday at the Congress Biotecnologia 2012. During the clinical trials carried out in Cuba and Bangladesh, Nasvac reported a better response than any other compound to treat that illness, Doctor Gerardo Guillén, vice president of the Organizing Committee of the event told reporters. Nasvac allows leading the patients' immune response to the virus and preventing the disease from worsening, the expert said. Effectiveness and benefits are already palpable, he said. Participants in the congress also learned about the results of clinical trials of anothr therapeutic vaccine against hepatitis C, as well as a drug against womb cancer. Regarding the vaccine against womb cancer, the head of the Research Project and Product Development at the Havana-based Genetic Engineering and Biotechnology Center (CIGB), Silvio Perea, told Prensa Latina that it is a synthetic peptide capable of blocking the enzyme casein kinase two (CK2), causing the programmed death of tumor cells. 古巴参展对乙型肝炎PDF Imprimir电子邮件的治疗性疫苗的研究进展 IMAGEN activaHavana,3月8日(拉丁新闻社)古巴专家正在对候选疫苗对B型肝炎,在临床试验的结果令人鼓舞,将于周四在国会Biotecnologia2012。 在古巴和孟加拉国进行的临床试验期间,Nasvac报道事件组委会副总裁赫拉尔多·纪廉,更好的反应比任何其他化合物治疗疾病,医生告诉记者。 专家说,nasvac可以导致病人的免疫反应的病毒,防止疾病恶化。 有效性和好处已经显而易见的,“他说。 在大会的与会者还了解anothr抗丙型肝炎治疗性疫苗,以及对子宫癌的药物临床试验的结果。 关于对子宫癌的疫苗,在哈瓦那遗传工程和生物技术中心(CIGB),西尔维奥·佩雷亚,该研究项目和产品开发的负责人告诉新闻报拉丁,它是一种人工合成的肽能够阻断酶酪蛋白激酶两种(CK2的),导致肿瘤细胞程序化死亡。 |
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