N/A
N=82
A Prospective Study of HBV Immunity and HBV Vaccination in Patients With NAFLD in Canada
Non-Alcoholic Fatty Liver Disease · Hepatitis B · Vaccine Reaction
Bottom Line
View on ClinicalTrials.gov: NCT02985450 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Anti-HBs Titres (IU/L) — 642; 385 Anti-HBS IU/L — p=0.02
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Engerix-B (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Calgary
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-HBs Titres (IU/L) |
642; 385 | 0.02 sig |
| PRIMARY Assessment of Memory T Cells and HBsAg-specific-proliferation of CD3 + CD4+ TH Cells |
5.1; 3.1 | — |
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.
Eligibility 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 60 y will be excluded, due to effect of age and reduced response to HBV vaccination.
Data sourced from ClinicalTrials.gov (NCT02985450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.