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

NCT02985450 | Completed Results

• 1 other identifier: REB16-0274
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

(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.

Conditions

Non-Alcoholic Fatty Liver Disease; Hepatitis B; Vaccine Reaction

Outcome Measures

Primary Outcomes (2)

• Anti-HBs Titres (IU/L)

  to determine how NAFLD-associated metabolic risk factors and liver inflammation / fibrosis affects vaccine response

  1 month after completion of the vaccine series

• Assessment of Memory T Cells and HBsAg-specific-proliferation of CD3 + CD4+ TH Cells

  to determine how NAFLD-associated metabolic risk factors and liver inflammation / fibrosis affects vaccine response. Fresh (or cryopreserved in 4 patients) PBMC (\~106) were labeled with 1 μM carboxyfluorescein-diacetate-succinimidyl-ester. Labeled PBMC were stimulated with 5 μg HBsAg) in RPMI 1640 with 10% FBS and 2mmol/L glutamine. Anti-CD3 (1 μg/mL) and anti-CD28 (5 μg/mL) stimulated cells served as a positive control. Unstimulated DMSO-treated cells were used as negative controls. Cells were cultured in triplicates and plates incubated at 37 °C with 5% CO2 for \~8 days. Cell proliferation was assessed on day 8. SI was calculated as % CFSE low cells in stimulated cells / % CFSE low cells in the unstimulated control46. SI\> 3 was considered positive for HBsAg-specific proliferation. Cells were stained using the memory T-cell panel and analyzed by flow-cytometry

  1 month after completion of the vaccine series

Interventions

Engerix-B BIOLOGICAL

Hepatitis B Vaccine

Also known as: Twinrix

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

NAFLD patients will be recruited from large tertiary liver clinics in Canada

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

PBMCs will be cryopreserved to assess HBV specific T and B cell responses.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Hepatitis B

Interventions

Engerix-B; twinrix

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis

Results Point of Contact

• Title: Dr.
• Organization: Carla Coffin

cscoffin@ucalgary.ca

403-220-7808

Study Officials

• Carla Coffin

  University of Calgary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 7, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: November 3, 2021
• Results First Posted: November 3, 2021

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)