Hepatitis B Vaccination, HIV Clinical Trial
Official title:
Immunogenicity and Safety of 4- vs. 3-standard Doses HBV Vaccination in HIV-infected Adults With Isolated Anti-HBc Antibody
The finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active hepatitis could cause by several scenarios, including false positive, remote infection without viremia, and occult infection with low viremia. Hepatitis B virus (HBV) vaccine booster could be a great prevention strategy for those who do not have HBV viremia. There is no standard consensus for management of this issue especially among HIV infected population. In addition, prior studies revealed that HIV-infected individuals had lower immunologic response to HBV vaccine than general population. This study intends to compare the immune response and safety of 4- versus 3-standard dose of hepatitis B virus vaccination in HIV-infected adults who has isolated HBc. The immunologic response will be evaluated after the participants receive vaccination.
| Status | Recruiting |
| Enrollment | 96 |
| Est. completion date | July 1, 2018 |
| Est. primary completion date | February 1, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Aged = 18 years - On combination antiretroviral therapy (cART) - CD4 = 200 cell/mm3 for = 1 year - HIV viral load < 20 copies/ml for = 1 year - Isolated anti-HBc Ab (negative HBsAg, anti-HBs Ab) and negative anti-HCV at screening Exclusion Criteria: - Pregnancy - Previous HBV vaccination - Intolerance to any component of HBV vaccine - Transaminitis in the past 3 months (= 5 UNL) - Ongoing opportunistic infection (OI) - Active malignancy, with current chemotherapy or radiotherapy - Systemic steroid therapy (= 0.5 mg/kg/day) or any immunomodulating therapy in the last 6 months - Other immunocompromised disorders (e.g. solid organ transplant) - Asplenism - Renal insufficiency (CrCl = 30 mL/min) - Decompensated cirrhosis (Child-Pugh C) |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai University | Muang, Chiang Mai | Chiang Mai |
| Lead Sponsor | Collaborator |
|---|---|
| Chiang Mai University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab = 10 mIU/mL ) at week 28 | Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab = 10 mIU/mL ) at week 28 | 28 weeks after the first dose of HBV vaccination | |
| Secondary | Anamnestic response at week 4 | Anamnestic response at week 4 | 4 weeks after the first dose of HBV vaccination | |
| Secondary | Percentage of responders (with anti-HBs Ab = 10 mIU/mL) at month 12 | Percentage of responders (with anti-HBs Ab = 10 mIU/mL) at month 12 | 12 months after the first dose of HBV vaccination | |
| Secondary | Percentage of high-level responders (with anti-HBs Ab = 100 mIU/mL) at week 28 and month 12 | Percentage of high-level responders (with anti-HBs Ab = 100 mIU/mL) at week 28 and month 12 | 28 weeks and 12 months after the first dose of HBV vaccination | |
| Secondary | Intensity and frequency of vaccine adverse event (AE) | Intensity and frequency of vaccine adverse event (AE) | 1 year | |
| Secondary | Geometric mean titers of anti-HBs Ab at week 28 and month 12 | Geometric mean titers of anti-HBs Ab at week 28 and month 12 | 28 weeks and 12 months after the first dose of HBV vaccination | |
| Secondary | Predictive factors associated with response to vaccine (age, sex, CD4 count) | Predictive factors associated with response to vaccine (age, sex, CD4 count) | 1 year |