Active clinical trials for "Hepatitis"

Chronic Hepatitis B virus (HBV) infection is a neglected disease with devastating consequences, particularly in countries with limited resources for the health sector. Mother-to-child-transmission (MTCT) is responsible for around 50 % of the HBV infections in Tanzania which, in 90 % of the cases, lead to a chronic HBV infection of the child. This infection rate could be reduced with an active immunization directly after birth which is recommended by the World Health Organization (WHO). However, the Tanzanian national immunization programme schedules the first Hepatitis B vaccination for the fourth week after birth which is too late to prevent a perinatal transmission. The aim of the study is to determine the prevalence of Hepatitis B surface antigen (HBsAg) in pregnant women in rural and urban study sites in the region of Mwanza, Tanzania. The blood from the positive -testing mothers should be further examined for viral load, genotype of the virus and for liver transaminases in order to conceive a better understanding of the progression of the infection. Beside the laboratory parameters, risk factors for the infection should be determined with the use of a questionnaire. Furthermore we would like to assess the number of children who were already infected, during the intrauterine period or during birth.

The goal of this trial is to evaluate the performance of the Fujirebio INNOTEST® HCV Ab IV using simpler collection methods such as fingerstick and venous whole blood collection on dried blood spots (DBS). In order to assess performance in samples with high and low antibody titres, performance will be evaluated with undiluted samples of all trial participants and serial diluted samples for a subset of HCV antibody reactive samples. Serial dilution of reactive samples will provide further insights into the potential difference of sensitivity in samples collected on DBS versus plasma. Results of this trial will also support the update of the regulatory claims to include DBS as an alternative sample type.

With 2.5% prevalence in general population, Pakistan is an intermediate endemicity country for hepatitis B. However, wide disparity exists across the country as disease prevalence in general population soars as high as 14% in hyper endemic areas. This hyper endemicity increases the risk of acquiring infection via vertical and horizontal routes of disease transmission. National immunization schedule in Pakistan administers the first vaccine against hepatitis B at 6th week after infant birth. Owing to this 6 week interlude the existing immunization schedule may not provide adequate protection to a newborn against the disease. A monovalent hepatitis B vaccination shot, administered within 12 hours of birth, is the preferred strategy for disease control in hyper endemic areas. The National Immunization Technical Advisory Groups around the world are expected to use rigorous scientific evidence and make changes in the immunization schedule and vaccine dosage, responding to the evolving epidemiology of childhood diseases. Such research on local evidence for hepatitis B vaccine in Pakistan is not available and our research fills this gap by This research studied the hepatitis B vaccine response, in two cohorts of healthy infants. An open labeled, randomized controlled, non-inferiority, vaccine trial methodology was used. Margin of non non-inferiority (Δ) was set at 5%. The trial administered hepatitis B birth dose as an intervention and vaccination done under the national immunization schedule was taken as standard of care.

This was a single-blind, 3-arm, comparative, controlled, randomized, study conducted at one site in Vietnam whose primary objective was to demonstrate clinical equivalence of the two production lots of Sci-B-Vac vaccine produced at two different facilities (OLD facility (Lot A) and NEW facility (Lot B) with respect to anti-hepatitis B-Surface (HBs) response. Secondary efficacy analysis was performed to demonstrate non-inferiority of seroprotection of each lot of Sci-B-Vac vaccine when compared to Engerix-B vaccine

The purpose of this study is to investigate the efficacy and safety of lenvatinib plus nivolumab compared with lenvatinib monotherapy for patients with advanced hepatitis B virus infection-related hepatocellular carcinoma.

The main purpose of the study is to compare the acceptance and viability of three strategies aimed to screen hepatitis C virus (HCV) infection in a birth cohort by: a) invitation letter offering HCV screening with dried blood spot (DBS) testing at the primary care center, b) invitation letter offering both HCV and colorectal cancer (CCR) screening with faecal occult test (FOT) at the primary care center, and c) invitation letter offering self-collected screening at home for HCV and CCR.

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B

This study has been designed to support the indication of the candidate vaccine (also referred to as GSK 257049 or RTS,S in this record) against hepatitis B virus infection, when administered as a primary vaccination integrated into an Expanded Program on Immunization (EPI) regimen to infants living in sub-Saharan Africa.

This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune response to the challenge dose of Engerix™-B.

Prevention of perinatal transmission is essential to decrease the global burden of chronic HBV. Recombinant HBV vaccine and hepatitis B immunoglobulin (HBIG) given after delivery to the newborns of HBsAg positive mothers is the standard of care for prevention of HBV in babies. Some studies have however, shown that vaccine alone may be equally effective. Hence, immunoprophylaxis with hepatitis B vaccine with or without HBIG is effective in prevention of transmission of overt HBV infection to the babies. The primary outcome measure of most of the trials on immunoprophylaxis was the occurrence of hepatitis B, defined as a blood specimen positive for hepatitis B surface antigen (HBsAg). However, whether this immunoprophylaxis also prevents HBsAg negative HBV infection (occult HBV infection) in babies is not known. In the present study the investigators evaluated the efficacy of the two regimens; vaccination alone and compared it with vaccination plus HBIG administration at birth in preventing transmission of both overt and occult HBV infection to the newborn babies.