Chronic C hepatitis carriers (B 18.2)
Conditions
Interventions
Butang® Vaccine administrated to chronic C hepatitis carriers in two different groups, being:
group A (n=70): 40ug and group B (n=70): 20ug in immunization conventional strategy (0, 1 and 6 months) an
in the following appointments to administrate the 3 dose-vaccination (2nd,3rd,4th).
In the last appointment (5th ) was to collect blood samples to assess Anti-HBs formation.
Sponsors
Faculdade de Medicina da Universidade de São Paulo
University of California San Francisco (UCSF), San Francisco, USA.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. ;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). | — |
Countries
Brazil
Contacts
Public ContactROSEANE MEDEIROS
Outcome results
None listed