Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 116 of 362 for:    hepatitis b | Open Studies

A Prospective Study of HBV Immunity and HBV Vaccination in Patients With NAFLD in Canada

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by University of Calgary
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Information provided by (Responsible Party):
University of Calgary
ClinicalTrials.gov Identifier:
NCT02985450
First received: December 1, 2016
Last updated: December 7, 2016
Last verified: December 2016
  Purpose
(1) Due to missed childhood vaccination programs, the majority of adult patients with NAFLD in Canada do not have immunity to hepatitis B. (2) Adults with NAFLD who receive the HBV vaccine have reduced immunogenic responses in the setting of obesity (i.e., protective anti-HBs titres). Aims: (1) To determine the sero-prevalence of immunity against hepatitis B in a cohort of prospectively evaluated adult NAFLD patients. (2) To prospectively determine HBV vaccine responses (anti-HBs titres) in adult NAFLD patients.

Condition Intervention
Non-Alcoholic Fatty Liver Disease
Hepatitis B
Vaccine Reaction
Biological: Energix-B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Hepatitis B Virus (HBV) Immunity and Hepatitis B Vaccination in Patients With Non Alcoholic Fatty Liver Disease (NAFLD) in Canada

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • anti-HBs titres (mIU/ml) [ Time Frame: 1 month after completion of the vaccine series ]
    to determine how NAFLD-associated metabolic risk factors and liver inflammation / fibrosis affects vaccine response

  • HBsAg specific B cell response [ Time Frame: 1 month after completion of the vaccine series ]
    to determine how NAFLD-associated metabolic risk factors and liver inflammation / fibrosis affects vaccine response

  • HBsAg specific T cell response [ Time Frame: 1 month after completion of the vaccine series ]
    to determine how NAFLD-associated metabolic risk factors and liver inflammation / fibrosis affects vaccine response


Biospecimen Retention:   Samples With DNA
PBMCs will be cryopreserved to assess HBV specific T and B cell responses.

Estimated Enrollment: 300
Study Start Date: August 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: Energix-B
    Hepatitis B Vaccine
Detailed Description:

The hepatitis B virus (HBV) is truly a global human pathogen that affects at least 2 billion people worldwide including ~240 million chronic hepatitis B (CHB) carriers that are at risk for end-stage liver disease. The diagnosis of CHB is confirmed by the persistence of the HBV surface antigen (HBsAg) in serum for >6 months. However, a latent form of HBV infection known as occult hepatitis B infection (OBI) characterized by low-level viremia (i.e., HBV DNA < 200 IU/ml) despite undetectable serum HBsAg has been described with unclear clinical consequences.

A safe and effective HBV vaccine has been available for ~3 decades and consists of recombinant HBsAg which contains the major viral antigenic epitopes and induces a protective neutralizing antibody to HBsAg (anti-HBs) response in >85% of children vaccinated. Canada is a low HBV-endemic region and in Alberta, and Ontario, public health uses maternal screening for HBsAg to identify babies at-risk for CHB. Thus, all infants born to HBsAg (+) mothers are given passive-active immunoprophylaxis with hepatitis B immune globulin (HBIG) and the HBV vaccine within 12 hours of birth, as well as 2 doses at ~2 and ~6 months of age. Testing of the infants for anti-HBs is recommended at 9 months to ensure immunity. In the late 1990's, a universal HBV childhood vaccination program was initiated in all Canadian provinces and jurisdictions. In Alberta and in Ontario, school-age children are scheduled to receive the 3-dose HBV vaccine series in grade 5. However there remain a significant proportion of adult Canadians (i.e., born before 1985) who missed childhood vaccination programs. Although current guidelines recommend that certain high-risk populations receive hepatitis B immunization, appropriate identification and compliance is generally much lower in adults compared to children.

According to the most recent Canadian Association for the Study of Liver Disease guidelines, all adults with diabetes, as well as all patients with chronic liver disease should receive the hepatitis B vaccine. The basis for these recommendations are two-fold, (1) diabetics may be at risk of blood-borne virus (BBV) exposure through contact with contaminated blood glucose monitoring devices and (2) diabetic patients are at increased risk of the metabolic syndrome and the development of non-alcoholic fatty liver disease (NAFLD). The improvement in blood glucose monitoring devices, and increased knowledge has reduced the risk of HBV exposure in patients with diabetes. Further, the investigators' initial seroepidemiological survey of acute HBV outbreaks in Alberta revealed a decreasing prevalence in diabetic patients. Therefore the main incentive for HBV vaccination in diabetics is due to the concomitant risk of the metabolic syndrome and advanced liver disease due to NAFLD. There is limited data on HBV vaccination in NAFLD patients. Further studies are required in a North American adult (Canadian population).

The investigators propose that adults with NAFLD should undergo comprehensive screening for hepatitis B immunogenicity, in addition to screening for infection, and catch up or booster vaccinations should be administered to non-immunized patients with confirmatory immunity testing thereafter.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NAFLD patients will be recruited from large tertiary liver clinics in Canada
Criteria

Inclusion Criteria:

  • Subjects 18-60 years of age, who provide signed informed consent
  • Diagnosis of NAFLD/NASH according to expert assessment (by imaging, TE, abnormal lab tests and/or liver biopsy)
  • No evidence of prior infection or immunity to hepatitis B (negative HBsAg, anti-HBs, anti-HBc).

Exclusion Criteria:

  • Subjects < 18 years of age,
  • Subjects who refused vaccination
  • Have documented immunity / prior exposure to hepatitis B (i.e., positive for ant-HBs, anti-HBc, HBsAg)
  • Pregnancy
  • HIV-positive
  • Decompensated cirrhosis (i.e., Child-Pugh Class B or C) due to impact on immune response.
  • Subjects >60 y will be excluded, due to effect of age and reduced response to HBV vaccination.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02985450

Contacts
Contact: Pam Crotty 403-592-5076 pcrotty@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Breean Haslam       breean.haslam@albertahealthservices.ca   
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Investigators
Principal Investigator: Carla Coffin University of Calgary
  More Information

Responsible Party: University of Calgary
ClinicalTrials.gov Identifier: NCT02985450     History of Changes
Other Study ID Numbers: REB16-0274
Study First Received: December 1, 2016
Last Updated: December 7, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 25, 2017