Assessment of antibodies protection formation in chronic non-cirrhotic Hepatitis C carriers after being exposed to two Hepatitis B vaccine regimens

Not Applicable

Active, not recruiting

• Conditions: Chronic C hepatitis carriers (B 18.2); health controlsTo evaluate the Anti-HBs formation in chronic C hepatitis carriers (VHC) submitted to two different doses anti-HBV vaccine (Butang® vaccine) and administer the 4th additional dose in non-responders as well as assess the maintenance of seroprotectors titers in this aimed public. Besides that to evaluate the Anti-HBs formation in chronic C hepatitis carriers (VHC) immunized with Anti-HBV vaccine (Butang® vaccine) and compare them to health controls.

• Registration Number: RBR-10ppxgw6
• Lead Sponsor: Faculdade de Medicina da Universidade de São Paulo

Brief Summary

INTRODUTION: Hepatitis B virus (VHB) vaccination is regarded as the most effective method for the prevention and control of VHB infection. Studies showed a reduced VHB vaccine response between patients with chronic hepatitis C (VHC), but studies exploring VHB vaccine efficacy in this population have equivocal results. OBJECTIVES: To evaluate VHB vaccine response in patients with VHC submitted to two different (20 µg vs 40 µg in 0, 1 and 6 months) anti-HBV vaccine schemes and administer the 4th additional dose in non-responders as well as assess the maintenance of seroprotectors titers. METHODS: This randomized controlled trial included 141 VHC who received double dose (40ug) or standard dose (20ug) and 70 healthy volunteers who received standard dose (20ug) at 0, 1 and 6 months. Anti-HBs titers were measured at 1 month after last dose. Vaccine response was defined by anti-HBs =10 U/L. Non-responders received the fourth dose according to the group that were previously randomized. Multivariate regression was modeled as a logistic regression. RESULTS: 128 completed the study. Median age 51 years, 61% female, 52% white, 40% F2-3, and 75% GT1, median 6 log10 VHC-RNA. Overall seroconversion rate was 76.7% (n=60) in double dose and 73.5% (n=68) in standard dose, compared to 92.6% in controls (n=68). 23 patients received the fourth dose; 7 seroconverted (30.4%) and seroconversion rate for double and standard doses were 42.9% and 11.1%, respectively (p=0.18). Controlling for confounders, only older age (p<0.001) and GT1 (p=0.005) were associated with a decreased anti-HBs response. CONCLUSION: In VHC-infected patients without cirrhosis, responses to VHB vaccination are significantly impaired and this reduced response cannot be overcome by the use double dose. Besides that, 4th dose VHB vaccination can be a strategy efficacious this vulnerable population

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-04-06
• Study Start: 2021-07-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

GROUPS A and B: chronic C hepatitis carriers; age similar or superior to 18 years; absence of cirrhose; infection documented by VHC (antiVHC quantitative PCR for VHC); patients non immunized against VHB; availability to collect blood samples after the administration of the anti HBV for analysis. GROUP C: health controls; age similar or superior to 18 years; patients non immunized against VHB; health individuals with negative serologies to VHB and VHC; availability to collect blood samples after the administration of the antiHBV for analysis.

Exclusion Criteria

Age above 18 years old; presence of cirrhose; absence of Infection documented by C virus in the selected patients for A and B groups; patients previously immunized against VHB; impossibility to collect blood samples after the administration of the antivaccine HBV for analysis.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of the immunogenicity response to chronics carriers VHC submitted to differents doses from the vaccine against virus of the B hepatitis (VHB) through collect of serology Anti-Hbs after last dose vaccine. The results were assessed through higher or egual anti-HBs (= 10 IU/mL) serology collected. <br>

Secondary Outcome Measures

Name	Time	Method
To estimate immunogenicity response to chronics carriers VHC immunized against VHB compared to health controls through collect of serology Anti-HBs after last dose vaccine. These results were assessed through the global stipulated seroconversion between chronic C hepatitis carriers (groups A and B) compared to health controls (group C). <br>;To evaluate vaccine response in VHC chronic carriers non-responders to a three dose vaccine strategy to anti-HBV when submitted to additional 4th dose vaccine. These results were obtained through Anti-HBs=10 IU/mL serology when these individuals were revaccinated with the same dose, according to a previously randomized group.<br><br>