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85 active trials for Hepatitis B

Hepatitis B and Hepatitis C as Risk Factors for Hepatocellular Carcinoma in African and Asian Immigrants

The prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) in the United States (US) is relatively low. However, immigrant populations in the US from Asia and sub-Saharan Africa have substantially higher prevalence than the general population and are consequently at a significant risk for hepatocellular carcinoma (HCC). Indeed, the age-adjusted incidence rates for HCC in the US have tripled from 1975 to 2005. As the population demographics have changed, the 2000 US census estimated the number of Somalis in Minnesota at 25,000 but current estimates put the number at around 50,000 due to primary refugee arrivals as well as secondary immigration from other states. There is no available data for Somali immigrants in the US on HBV and HCV prevalence, HBV and HCV genotypes/subgenotypes, and genetic and immunologic risk factors predisposing Somalis to HBV and HCV and the subsequent development of HCC. Therefore. this study will fill these gaps in the Somali population to understand the relative importance of HBV and HCV infections in causation of HCC. Besides Somalis, Minnesota is also home to large other African immigrant communities. According to the Minnesota Department of Health (MDH), in 2013, the highest rates of chronic HBV cases where reported among Asian or Pacific Islanders (3,638 cases per 100,000 persons) followed by Black or African Americans (2,078 cases per 100,000 persons). Additionally, Minnesota receives a large number of new refugee's resettlement. It is important to improve the identification of chronic HBV and HCV infections among Somali refugees and immigrants in Minnesota through well-designed community-wide screening efforts. Since we know that African immigration to Minnesota is the third highest in the US, this unique population might be a contributing factor to the increased burden of hepatitis and liver cancer complications in the state of Minnesota. Findings from HBV and HCV screening among Somalis suggest that other immigrant African populations from high viral hepatitis endemic regions, such Ethiopia, Liberia, and Kenya, are also at substantial risk of HBV, HCV and HCC. Unfortunately, very little research has been conducted in the US on the burden of hepatitis and liver cancer in African Immigrants from areas of high endemicity of hepatitis B and hepatitis C. Therefore, the goal of is to identify HBV and HCV and the role viral genetics and immune response among African immigrant communities from Kenya, Liberia, and Ethiopia.

Start: November 2010
Neovac 2 Burkina Faso: Impact of the Integration of Hepatitis B Birth Dose Vaccine Into the Infant Immunization Schedule

Hepatitis B virus (HBV) infection is an important global health problem, and the WHO adopted a strategy to eliminate HBV infection as a public health threat by the year 2030. In order to eliminate, it is critical to prevent the mother-to-child transmission (MTCT) of hepatitis B. Since 2009, the WHO recommends to administer hepatitis B vaccine within 24 hours of birth to prevent MTCT.2 However, in Africa, the majority of countries provide hepatitis B vaccine as a combined vaccine (pentavalent or hexavalent) at the age of 6-10-14 weeks or 8-12-16 weeks after the birth, and only 10 sub-Saharan African countries integrated birth dose vaccine into their national immunization program. This is because, the GAVI, the Vaccine Alliance, does not support monovalent hepatitis B vaccine, and also about half of babies in Africa are born at home without the immediate access to vaccination. Moreover, the evidence base to support this WHO's recommendation to start immunizing immediately at birth, rather than later at 6-8 weeks of life, is not strong. Through a multidisciplinary approach comprising epidemiological, anthropological and economic components, the primary objective of the study is to measure the impact of the introduction of birth dose hepatitis B vaccine into the infant immunization program in Burkina Faso. Expected results will be to develop strong evidence base (effectiveness & cost-effectiveness) to recommend the integration of birth dose hepatitis B vaccine into the current vaccination schedule (8-12-16 weeks as a combined vaccine), to facilitate the Burkinabé Government to include the birth dose hepatitis B vaccine in their national vaccination program, to inform other African countries which have not yet integrated the birth dose hepatitis B vaccine in their national program and to imply whether additional strategy (e.g., maternal screening and antiviral therapy during pregnancy) might be necessary in order to eliminate the risk of mother-to-child transmission of hepatitis B.

Start: October 2020
Nurse-led Decision Counseling on Hepatocellular Carcinoma Screening

Hepatocellular carcinoma (HCC) is a common malignancy with poor prognosis worldwide. The asymptomatic of early-stage HCC may lead most patients diagnosed at advanced stages. This highlights the importance of HCC screening among high-risk populations to detect HCC at early stages and achieve better survival. Hepatitis B virus (HBV) infection is a major cause of HCC in China, but the utilization of HCC screening is suboptimal among patients with HBV infection. Currently, there are no-theory based intervention, to our knowledge, has been reported to improve HCC screening decision-making and uptake among patients with HBV infection . Therefore, based on our previous systematic review, the current study has proposed a nurse-led decision counseling program to improve decision-making and uptake of HCC screening among patients with HBV infection in mainland China. Participants in intervention group will receive nurse-led decision counseling. The intervention components include 40-minute education and tailored information regarding HCC screening. At the second week, decision support will be provided through 30-minute telephone call. At the third week, another telephone call (20 minutes) will be provided to help participants identify and address barriers to HCC screening. Participants in control group will receive usual care. After the intervention and at 3-month follow-up, the study will collect data related to HCC screening uptake rates. Findings are paramount to promote informed choice in HCC screening and early HCC detection to improve survival outcomes among patients with HBV infection.

Start: January 2021
A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses

Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in HIV-infected individuals, including more rapid progression to cirrhosis and associated complications such as hepatocellular carcinoma. For this reason, as well as the shared routes of transmission between the two viruses, UK and International guidance recommends that all HBV-negative HIV-infected individuals be offered vaccination against HBV. Unfortunately, response rates in this population can be as low as 17.5 - 40% to standard vaccination courses. To improve this response, strategies such as the use of double dose of standard vaccines (e.g. Engerix B) is recommended in several guidelines for previous non-responders, although there is currently limited evidence for this approach. An alternative strategy is to use vaccines with novel adjuvants such as Fendrix and observational clinical data in the Investigators HIV cohort suggests that response rates can be as high as 81% of individuals achieving HBV surface antibody (HBsAb) levels >100 in a group that did not respond to previous standard HBV vaccine courses. However, the cost of Fendrix is considerably higher than Engerix B and controlled trials are required to confirm whether this approach is warranted. Furthermore, insights into the potential mechanisms by which Fendrix may elicit better responses would be valuable in optimising future vaccine strategies in this population. The Investigators propose to conduct a randomised, open label, active-controlled pilot study comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV vaccine courses, which will provide the necessary data to design and power a larger multicentre randomised controlled trial. Outcome measures will include the proportion of individuals seroconverting with HBsAb levels >100 following each vaccination course, the magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and the durability of the HBsAb response at 1 year following the end of vaccination.

Start: August 2015