Hepatitis B Vaccination in HIV-infected Adults With Low CD4 Cell Counts

HIV-infected adults with CD4+ cell counts < 200 cells/mm3, undetectable plasma HIV-1 RNA, and negative for all HBV markers were randomly assigned to receive one of these 2 regimens of recombinant hepatitis B vaccine (Centro De Ingenieria Genetica Y Biotecnologia, La Habana, Cuba); 1) 20 μg IM at months 0, 1, and 6 (3-standard doses group), and 2) 20 μg IM at months 0, 1, 2, 6 (4-standard doses group).

This study aimed to evaluate the efficacy and safety of these 2 hepatitis B vaccination regimens at month 7 after vaccination.

Inclusion criteria

• HIV-infection
• ≥18 years old
• Received combination antiretroviral therapy for at least 1 year
• Had a CD4+ cell count < 200 cells/mm3 for at least 1 year
• Undetectable plasma HIV-1 RNA for at least 1 year
• Negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc),
• Had no history of previous HBV vaccine
• Negative for antibody to hepatitis C virus (anti-HCV)
• No active opportunistic infections (at the time of screening)
• Willing to sign an informed consent
• Able to return for follow-up.

Exclusion criteria

• Pregnancy or lactation
• History of hypersensitivity to any component of the vaccine
• Active malignancy receiving chemotherapy or radiation, or other immunocompromised conditions besides HIV (e.g., solid organ transplant), received immunosuppressive (e.g., corticosteroid ≥ 0.5 mg/kg/day) or immunomodulating treatment in the last six months before screening visit
• Renal insufficiency (creatinine clearance <30 mL/min)
• Decompensated cirrhosis (Child-Pugh class C)