View clinical trials related to Hepatitis B.
Filter by:The purpose of this study is to evaluate the safety and immunogenicity of the recombinant hepatitis B vaccine (Hansenula polymorpha, 10μg), with an open-labelled design in adults and randomized, double-blinded, and positive controlled design in children and neonates.
The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj. and Imovax® Polio in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants and thereby to select the optimal dose of candidate vaccine
Hepatitis B virus (HBV) has infected over one third of the world's population; of these about 350 million go on to be chronic carriers. Infection with HBV can be self-limiting depending on age and immunity status of the infected person. Acute infection with HBV is cleared within six months of initial infection while chronic infection can last longer than six months. HBV can be transmitted perinatally, sexually, horizontally, through direct contact with infectious body fluids or blood, being pricked with an infected needle and injury from instruments contaminated with infectious body fluid or blood. Certain population groups are at higher risk of infection with HBV. Among these populations is that of health care workers (HCWs). In this population, HBV infection can occur through occupational exposure. In fact, the hepatitis B virus is more contagious than human immunodeficiency virus (HIV) during a needle stick injury (30% versus 0.5%). It is therefore imperative that HCWs are highly knowledgeable about HBV and how they can prevent transmission. Protection from HBV infection can be achieved by means of vaccination after which the HBV vaccine has been shown to be 90-100% effective.
Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B
The objective of this study is to identify immunological mechanisms that contribute to normalization of liver inflammation in chronic hepatitis B (CHB) patients starting the antiviral nucleoside analogue, Tenofovir alafenamide (TAF).
Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with previous antiviral resistance. This study evaluates the efficacy and safety of switching to generic entecavir 1 mg (Baracle®, Dong-A Science Technology) in CHB patients taking brand name entecavir 1 mg (Baraclude®, Bristol-Myers Squibb) alone or in combination with other nucleos(t)ide analogues after the development of antiviral resistance. The primary aim is virological response (<20 IU/mL) at 12 months
This study is a single-group, multi-center and prospective clinical study designed to assess the efficacy and safety of TAF in blocking mother-to-child transmission of hepatitis B virus.Pregnant women whose HBsAg and HBeAg are positive are included in the study.Eligible hepatitis B pregnant women are given TAF antiviral therapy at 24-28 weeks of gestation to block mother-to-child transmission and followed up during pregnancy and after delivery.The study will be initiated with approval by the central ethics committee.Subjects will start screening after signing the informed consent form. Those who meet the criteria will start taking TAF (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.At that time, chronic hepatitis B carrier will stop taking antiviral therapy, and patients with chronic hepatitis B decide whether to continue the therapy according to the patient's condition.The babies born are immunized according to the national standard immunization program,, that is, 100 IU of hepatitis B immunoglobulin (HBIG) and 10 μg/0.5 ml of hepatitis B vaccine are given within 12 hours after birth. And the same dose of hepatitis B vaccine is given at 1 month and 6 months of age.
Data on the prevalence of hepatitis C virus (HCV) for other vulnerable groups in Madrid, such as homeless persons and migrants, are scarce, and it is now necessary to implement intervention and elimination plans. Vulnerable groups have poor access to healthcare and are therefore not systematically screened for HCV. On the occasions they are shown to be positive, subsequent follow-up in the health system and the possibility of cure are poor. The use of a mobile unit to approach vulnerable populations is essential for better characterization of risk behaviors and of the magnitude of HCV. The integration of healthcare personnel in mobile units enables counseling on prevention and intervention when needed. Primary objective Evaluate the impact of the HCV care cascade on vulnerable populations who gather at hot spots in Madrid (shantytowns, homeless shelters and places were street prostitution is practiced) by means of a multilevel outreach project. SURVEILLANCE: Active screening for HCV among vulnerable individuals in populations with a high prevalence of HCV will be carried out in hot spots in Madrid, namely, Cañada Real shanty town, mobile harm reduction units, institutions providing social assistance, public areas, homeless shelters and places where street prostitution is practiced. An agreement with the Madrid Council (MCC) is under way to provide social centers for HCV screening. A mobile unit will approach the hot spots following a predefined schedule. The mobile unit consists of a van adapted for the project and a car. HCV screening of vulnerable individuals will be performed by a nurse and an educator hired specifically for that purpose. Active HCV screening and prevention in vulnerable individuals should be a priority and a responsibility shared by both the MCC and the SERMAS (Servicio Madridleño de Salud). The investigators plan to establish an agreement with public health authorities to give continuity to this project and to carry out proactive HCV screening through integration with various centers and networks dependent on the MCC and SERMAS. The project will establish the foundations of integrated cooperation between an HCV clinic in a hospital setting and harm reduction units and other resources and networks dependent on the institutions mentioned above. As has been observed with other interventions, the functional objective of this project is to provide continuity of care from the institutions. Study Duration (in months) 12 months.
An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B treatment-naive subjects with chronic HBV infection.
A prospective, open-label, interventional phase IV study to assess the safety of EupentaTM Inj.{fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [recombinant-deoxyribonucleic acid])-Haemophilus influenzae type b conjugate vaccine}