Hepatitis B Vaccination, HIV
Conditions
Keywords
HBV vaccination, HIV, isolated anti-HBc
Brief summary
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.
Detailed description
* 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
Interventions
BIOLOGICALHepatitis B vaccine
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)
Sponsors
Chiang Mai University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No masking
Intervention model description
Open-label, randomized controlled trial (RCT) with 1:1 allocation in parallel arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12 | 12 months after the first dose of HBV vaccination | Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at 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 | Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12 |
| Anamnestic response at week 4 | 4 weeks after the first dose of HBV vaccination | Anamnestic response at week 4 |
| 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 | Geometric mean titers of anti-HBs Ab at week 28 and month 12 |
| Predictive factors associated with response to vaccine (age, sex, CD4 count) | 1 year | Predictive factors associated with response to vaccine (age, sex, CD4 count) |
| Intensity and frequency of vaccine adverse event (AE) | 1 year | Intensity and frequency of vaccine adverse event (AE) |
Countries
Thailand
Contacts
Primary ContactRomanee Chaiwarith, MD
Backup ContactQuanhathai Kaewpoowat, MD
Outcome results
None listed