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.
* A randomized controlled trial to evaluate differences in immunogenicity and safety of the two hepatitis B vaccination regimens, including the percentage of responders, high-level responders, anamnestic response, geometric mean titers of anti-HBs antibody, adverse events and predictive factors associated with vaccine responsiveness * After participant enrollment, data on baseline characteristics, time since HIV diagnosis, CD4 counts, HIV viral load, antiretroviral treatment regimen and duration will be collected, then the participants will be randomized into 2 groups to receive either 3- or 4-standard doses (20 mcg per dose) of HBV vaccination, and follow-up blood test for anti-HBs titers at multiple pre-specified time points to evaluate outcomes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
96
Hepatitis B vaccine (20 mcg/ml) 1 ml intramuscular injection in 3 (at 0, 1, 6 months) or 4 doses (0, 1, 2, 6 months)
Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai University
Muang, Chiang Mai, Chiang Mai, Thailand
RECRUITINGImmunologic 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
Time frame: 28 weeks after the first dose of HBV vaccination
Anamnestic response at week 4
Anamnestic response at week 4
Time frame: 4 weeks after the first dose of HBV vaccination
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
Time frame: 12 months after the first dose of HBV vaccination
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
Time frame: 28 weeks and 12 months after the first dose of HBV vaccination
Intensity and frequency of vaccine adverse event (AE)
Intensity and frequency of vaccine adverse event (AE)
Time frame: 1 year
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
Time frame: 28 weeks and 12 months after the first dose of HBV vaccination
Predictive factors associated with response to vaccine (age, sex, CD4 count)
Predictive factors associated with response to vaccine (age, sex, CD4 count)
Time frame: 1 year
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