Robust Antibody and Cytokine Response to Hepatitis B Vaccine Among Not-in-treatment Patients With Chronic Hepatitis C：An Open-label Control Study in China

NCT02898922 | Completed Phase 4

• 1 other identifier: HCV-001
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background Hepatitis B virus (HBV) co-infection in individuals with hepatitis C virus (HCV) can enhance the severity of hepatitis and the risks of liver cirrhosis and hepatocellular carcinoma (HCC). Hepatitis B vaccine is an effective measure to prevent HBV infection. Whether patients with HCV infection have non-protective antibody responses to hepatitis B vaccination more frequently than healthy subjects is still controversial and studies about cytokine response have been seldom reported. Methods Not-in-treatment patients with chronic HCV infection and 1:2 community/gender matched healthy control were obtained from a community-based screening. All participants received three doses of hepatitis B vaccine (20 μg HBsAg/ml/dose) on 0, 1 and 6 months schedule. Anti-HBs was tested 1 month after the third dose of vaccination and was compared between two groups. Spot-forming cells (SFCs) of interferon-γ (IFN-γ), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5) and interleukin-6 (IL-6) produced by lymphocyte were tested by enzyme-linked immunospot (ELISPOT) and were compared between two groups.

Conditions

Hepatitis B Vaccines

Outcome Measures

Primary Outcomes (1)

• Antibody to the hepatitis B surface antigen response and cytokine response to hepatitis B vaccination in patients with chronic HCV.

  Three doses of hepatitis B vaccine made by Recombinant DNA Techniques in Saccharomyces Cerevisiae (20 μg HBsAg/1.0ml per dose, Shenzhen Kangtai Biological Products Co., Ltd., Shenzhen, Guangdong Province, China) were given intramuscularly in the deltoid region to all participants at 0, 1 and 6 months respectively. Blood samples from the participants were collected one month after the third dose of vaccination. Anti-HBs was assayed by Abbott Chemiluminesent Microparticle ImmunoAssay (CMIA) (Abbott Ireland Diagnostics Division, Sligo, Ireland) one month after the first and the third dose of vaccination. Spot-forming Cells (SFCs) were enumerated with ImmunoSpotTM system (Cellular Technology Ltd.). Differences between HCV group and healthy control group in anti-HBs and immunodotting spots were examined.

  one month after the third dose of vaccination

Secondary Outcomes (1)

• The occurrence and severity of solicited local reactions at the injection site, solicited systemic reactions, and any unsolicited adverse after hepatitis B vaccination in patients with chronic HCV

  from the first dose of vaccination to one month after the third dose of vaccination

Study Arms (2)

HCV group

EXPERIMENTAL

Three doses of hepatitis B vaccine made by Recombinant DNA Techniques in Saccharomyces Cerevisiae (20 μg HBsAg/1.0ml per dose, Shenzhen Kangtai Biological Products Co., Ltd., Shenzhen, Guangdong Province, China) were given intramuscularly in the deltoid region to all participants at 0, 1 and 6 months respectively.

Biological: hepatitis B vaccine made by Recombinant DNA Techniques in Saccharomyces Cerevisiae

Healthy control group

ACTIVE COMPARATOR

Three doses of hepatitis B vaccine made by Recombinant DNA Techniques in Saccharomyces Cerevisiae (20 μg HBsAg/1.0ml per dose, Shenzhen Kangtai Biological Products Co., Ltd., Shenzhen, Guangdong Province, China) were given intramuscularly in the deltoid region to all participants at 0, 1 and 6 months respectively.

Biological: hepatitis B vaccine made by Recombinant DNA Techniques in Saccharomyces Cerevisiae

Interventions

hepatitis B vaccine made by Recombinant DNA Techniques in Saccharomyces Cerevisiae BIOLOGICAL

20 μg HBsAg/1.0ml per dose, Shenzhen Kangtai Biological Products Co., Ltd., Shenzhen, Guangdong Province, China

HCV group; Healthy control group

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• (1) allergy to any vaccine component; (2) pregnancy or lactation; (3) axillary temperature ≥38℃ in the past three days, acute disease in the past seven days or vaccination history of any vaccine in the past four weeks; (4) suffering from diseases that may influence immune function, such as severe cirrhosis with Child-Pugh score \>5, renal failure, bleeding diathesis, malignant tumor and HIV infection; (5) have received or being taking antiviral treatment; (6) chronic liver diseases except causing by HCV.

Sponsors & Collaborators

• Shandong Province Centers for Disease Control and Prevention: lead
• Centers for Disease Control and Prevention, China: collaborator
• National Institutes for Food and Drug Control, China: collaborator

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2016
• First Posted: September 13, 2016
• Study Start: June 1, 2013
• Primary Completion: January 1, 2015
• Last Updated: September 15, 2016

Record last verified: 2016-09