HBV Vaccination in HIV-infected Adults

Chiang Mai University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B Vaccination, HIV

Treatments: Biological: Hepatitis B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03212911

04565

Details and patient eligibility

About

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.

Full 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

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

3-standard dose HBV vaccination group

Active Comparator group

Description:

participants will receive 3 standard doses of HBV vaccination at 0, 1, 6 months

Treatment:

Biological: Hepatitis B vaccine

4-standard dose HBV vaccination group

Active Comparator group

Description:

participants will receive 4 standard doses of HBV vaccination at 0, 1, 2, 6 months

Treatment:

Biological: Hepatitis B vaccine