View clinical trials related to Hepatitis B.
Filter by:In HIV infected patients, individuals exposed to the virus of Hepatitis B are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer. However, the existing protocol of vaccination against Hepatitis B is less efficient in HIV-infected patients than in non HIV-infected-patients, and, in case of response, its longevity has to be followed up carefully. This study compares the efficacy of the standard protocol vaccination with GenHevac-B and 2 other protocols, a double-dose of GenHevac-B and a set of intradermal injections of Genhevac-B, in HIV-infected patients with lymphocytes T CD4 level above 200 permm3.
The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.
The trial will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy treatment regimens.
The prevalence of Hepatitis B core antigen in the Thai population is about 70 %, no data of isolated Hepatitis B core antigen is reported. Hepatitis B core antigen is observed in 10%-20% of individuals from low endemic areas of HBV infection. However, this prevalence of isolated antiHBc would be higher in endemic area of HBV infection. There is conflicting data of occult HBV infection in HIV infected patients. In Thailand, perinatal transmission is the main route of transmission which is different from developed countries. Therefore, isolated antiHBc in Thai people has longer duration than low prevalence regions. Moreover, HBV genotype C and B is common in this region. If the HBV vaccination could eliminate an occult HBV infection in these individuals, the liver related mortality might be reduced. The prevalence and clinical importance of isolated antiHBc in Thai have not been investigated yet. There is also limited data of HBV vaccine response in this setting.
The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study.
The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00334334).
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
The current study will evaluate immunological memory to hepatitis B antigen in subjects who received primary neonatal vaccination of hepatitis B vaccine (Engerix™-B ), 20 years ago in the primary study and who have anti-HBs antibody concentrations < pre-defined cut-off values at the previous long-term time point. All participating subjects will receive a challenge dose of hepatitis B vaccine. Subjects will be aged approximately 20-21 years at the time of this study. No new subjects will be recruited in this long-term follow-up study. Blood sampling will be done one month after the administration of the challenge dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
The response to vaccination for hepatitis is reduced in patients with HIV infection. The hypothesis of the study is that adjuvant interleukin-2 administered subcutaneously at the time of vaccination improves the response rate.