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

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ClinicalTrials.gov Identifier: NCT01289106
Recruitment Status : Unknown
Verified January 2011 by Chiang Mai University.
Recruitment status was:  Recruiting
First Posted : February 3, 2011
Last Update Posted : February 3, 2011
Sponsor:
Information provided by:
Chiang Mai University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infection Biological: Hepavax-Gene Phase 3

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : January 2011
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : April 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm A
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
 Biological: Hepavax-Gene
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
Other Name: Berna
Experimental: Arm B
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
 Biological: Hepavax-Gene
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Other Name: Berna
Experimental: Arm C
40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
 Biological: Hepavax-Gene
40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Other Name: Berna


Outcome Measures
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Primary Outcome Measures :
  1. Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210 [ Time Frame: Day 210 ]
    1. To compare the seroconversion rate at day 210 of an intensive standard-dose regimen (0, 1, 2 and 6 months) to a standard-dose regimen (0,1 and 6 months)
    2. To compare the seroconversion rate at day 210 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


Secondary Outcome Measures :
  1. Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year [ Time Frame: 1 year ]
    To determine the seroprotective rate at 1 year of each of the vaccination regimens.

  2. Number of subjects with adverse events after vaccination [ Time Frame: 180 days ]
    Adverse events include pain at injected site, swelling at injected site, redness at injected site, fever, headache, fatique and anaphylaxis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289106


Contacts
Contact: Kanokporn Chaiklang, MD +66 89 8539864 kanokpornk@rihes.org

Locations
Thailand
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University Recruiting
Muang, Chiang Mai, Thailand, 50200
Contact: Kanokporn Chaiklang, MD    +66 89 8539864    kanokpornk@rihes.org   
Principal Investigator: Kanokporn Chaiklang, MD         
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Kanokporn Chaiklang, MD Faculty of Medicine, Chiang Mai University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kanokporn Chaiklang, Faculty of Medicine, Chiang Mai University
ClinicalTrials.gov Identifier: NCT01289106     History of Changes
Other Study ID Numbers: MED-10-10-21A-13
First Posted: February 3, 2011    Key Record Dates
Last Update Posted: February 3, 2011
Last Verified: January 2011

Keywords provided by Chiang Mai University:
Hepatitis B vaccine
HIV infection
Modified HBV vaccine dose
Modified HBV vaccine schedule

Additional relevant MeSH terms:
Hepatitis
HIV Infections
Hepatitis B
Liver Diseases
Digestive System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human