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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Chiang Mai University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01289106
First received: February 1, 2011
Last updated: February 2, 2011
Last verified: January 2011

February 1, 2011
February 2, 2011
January 2011
October 2011   (final data collection date for primary outcome measure)
Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210 [ Time Frame: Day 210 ] [ Designated as safety issue: No ]
  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
Same as current
Complete list of historical versions of study NCT01289106 on ClinicalTrials.gov Archive Site
  • Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To determine the seroprotective rate at 1 year of each of the vaccination regimens.
  • Number of subjects with adverse events after vaccination [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    Adverse events include pain at injected site, swelling at injected site, redness at injected site, fever, headache, fatique and anaphylaxis
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infection
  • Biological: Hepavax-Gene
    20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
    Other Name: Berna
  • Biological: Hepavax-Gene
    20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
    Other Name: Berna
  • Biological: Hepavax-Gene
    40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
    Other Name: Berna
  • Active Comparator: Arm A
    20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
    Intervention: Biological: Hepavax-Gene
  • Experimental: Arm B
    20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
    Intervention: Biological: Hepavax-Gene
  • Experimental: Arm C
    40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
    Intervention: Biological: Hepavax-Gene
Chaiklang K, Wipasa J, Chaiwarith R, Praparattanapan J, Supparatpinyo K. Comparison of immunogenicity and safety of four doses and four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: a randomized, controlled trial. PLoS One. 2013 Nov 12;8(11):e80409. doi: 10.1371/journal.pone.0080409. eCollection 2013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
132
April 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Kanokporn Chaiklang, MD +66 89 8539864 kanokpornk@rihes.org
Thailand
 
NCT01289106
MED-10-10-21A-13
No
Kanokporn Chaiklang, Faculty of Medicine, Chiang Mai University
Chiang Mai University
Not Provided
Principal Investigator: Kanokporn Chaiklang, MD Faculty of Medicine, Chiang Mai University
Chiang Mai University
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP