Procurement of Blood Samples for a Biomedical Research Program on T Cell Functional Response to Chronic HBV Infection

Vaccine and Gene Therapy Institute, Florida

Status: Unknown

Conditions: Chronic Hepatitis B

Study type: Observational

Funder types: Other

Identifiers

NCT02017587

HBV-001

Details and patient eligibility

About

The objective of the study is to procure blood (plasma, serum, RNA and PBMC samples) from approximately 40 chronic HBV for biomedical research program led by VGTI Florida.

Full description

During chronic HBV infection, a dynamic balance between viral replication and the host immune response is pivotal to the pathogenesis of liver disease. HBV specific T-cell function is impaired in patients with chronic HBV infection characterized by low levels of antiviral cytokines, impaired cytotoxic T lymphocyte activity, and persistent viremia. However, the mechanism underlying this T-cell malfunction in chronic HBV infection has not been completely understood.

The biomedical research on the samples obtained during this study will include, among other studies, advanced flow cytometry to study the Treg and activation markers, negative regulatory molecules and phenotype of CD4 and CD8 subsets using the extended panel markers developed at VGTI Florida. Additional antibody panels for measuring functional CD4 responses by ICS, DC subsets, activation, and signaling pathways by phos

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with chronic HBV infection documented by presence of HBsAg for at least 12 months currently untreated for HBV infection or under stable antiviral therapy

Exclusion criteria

• Prior use of HBV therapeutic vaccine
• Currently treated with interferon alpha or other immune modulator(s)
• Acute HBV infection
• Chronic inactive HBV carrier
• under an acute flare/reactivation of HBV infection defined as symptoms of acute hepatitis and recent elevation of aminotransferase (over 10 x ULN) or bilirubin levels
• Known co-infection with HCV, HDV, and/or HIV
• Under renal dialysis
• For female patients, pregnant or breastfeeding
• Cirrhosis, hepatocellular carcinoma or liver transplantation
• active autoimmune disease including autoimmune hepatitis

Trial design

40 participants in 1 patient group

Chronic HBV

Description:

chronic HBV strata: HBV tolerant, Chronic active HBe+ or HBe-, suppressed with antiviral therapy