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

Chiang Mai University

Status and phase: Unknown; Phase 3

Conditions: HIV Infection

Treatments: Biological: Hepavax-Gene

Study type: Interventional

Funder types: Other

Identifiers

NCT01289106

MED-10-10-21A-13

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 3 patient groups

Arm A

Active Comparator group

Description:

20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months

Treatment:

Biological: Hepavax-Gene

Biological: Hepavax-Gene

Biological: Hepavax-Gene

Arm B

Experimental group

Description:

20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

Treatment:

Biological: Hepavax-Gene

Biological: Hepavax-Gene

Biological: Hepavax-Gene

Arm C

Experimental group

Description:

40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months

Treatment:

Biological: Hepavax-Gene

Biological: Hepavax-Gene

Biological: Hepavax-Gene