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

February 2, 2011 updated by: Chiang Mai University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
        • Contact:
        • Principal Investigator:
          • Kanokporn Chaiklang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Berna
Biological: Hepavax-Gene
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Other Names:
  • Berna
Biological: Hepavax-Gene
40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Other Names:
  • 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 and 6 months
Other Names:
  • Berna
Biological: Hepavax-Gene
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Other Names:
  • Berna
Biological: Hepavax-Gene
40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Other Names:
  • Berna
Experimental: Arm C
40 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 and 6 months
Other Names:
  • Berna
Biological: Hepavax-Gene
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Other Names:
  • Berna
Biological: Hepavax-Gene
40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Other Names:
  • Berna

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 210

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Investigators

  • Principal Investigator: Kanokporn Chaiklang, MD, Faculty of Medicine, Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

February 1, 2011

First Submitted That Met QC Criteria

February 2, 2011

First Posted (Estimate)

February 3, 2011

Study Record Updates

Last Update Posted (Estimate)

February 3, 2011

Last Update Submitted That Met QC Criteria

February 2, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-10-10-21A-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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