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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm A

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

Group Type ACTIVE_COMPARATOR

Hepavax-Gene

Intervention Type BIOLOGICAL

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

Arm B

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

Group Type EXPERIMENTAL

Hepavax-Gene

Intervention Type BIOLOGICAL

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

Arm C

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

Group Type EXPERIMENTAL

Hepavax-Gene

Intervention Type BIOLOGICAL

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

Interventions

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Hepavax-Gene

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

Intervention Type BIOLOGICAL

Hepavax-Gene

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

Intervention Type BIOLOGICAL

Hepavax-Gene

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Berna Berna Berna

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No