Modified Dose and Schedule of Recombinant Hepatitis B Vaccination in HIV-infected Adult Subjects

Open-Label, Randomized Controlled Trial Comparing Three Strategies of Hepatitis B Vaccination in HIV-1-Infected Patients With CD4 Cell Counts Above 200 permm3 and Suppressed Viral Load

The purposes of this study include 1) to compare the seroconversion rate of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months), and 2) to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients.

HIV and HBV share similar risk factors and routes of transmission. HIV/HBV coinfection is associated with greater chance of chronic HBV carrier state, higher level of HBV replication and increasing its potential for transmission. Currently, there are no concrete data to determine the best HBV vaccination schedule in HIV-infected patients. Standard HBV vaccination (20 μg at 0, 1 and 6 months) gives seroconversion rate of 33-63% in HIV-infected individuals compared with >90% in healthy individuals. This study aims to compare the efficacy of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months) and to compare the seroconversion rate of an intensive double-dose regimen (40 μg at 0,1,2 and 6 months) to a standard-dose regimen (20 μg at 0,1 and 6 months) of HBV vaccine in HIV-infected adult patients with CD4 level above 200 permm3 and suppressed viral load.

Inclusion Criteria:

• Positive for anti-HIV antibody
• At least 18 years of age
• CD4 > 200 cell/mm3
• On antiretroviral therapy
• Viral load < 50 copies/ml
• Negative for any HBV serological marker (HBsAg, Anti-HBs, Anti-HBc)
• No history of previous hepatitis B vaccination
• Anti-HCV negative
• No active opportunistic infection at the time of screening
• Willing to sign informed consent
• Able to follow up

Exclusion Criteria:

• Pregnancy or breast feeding
• History of hypersensitivity to any component of vaccine
• Diagnosis of malignancy and receiving chemotherapy or radiation
• Other immunocompromised conditions not related to HIV infection (solid-organ transplantation, chemotherapy in the last 6 months)
• On Immunosuppressive treatment, immunomodulating treatment or corticosteroid (equal or above 0.5 mg per kg per day of prednisolone)
• Renal failure (creatinine clearance < 30 mL/min)
• Decompensated cirrhosis (child-pugh C)
• Not able to follow up