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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. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Chiang Mai University.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Chiang Mai University
Information provided by:
Chiang Mai University
ClinicalTrials.gov Identifier:
NCT01289106
First received: February 1, 2011
Last updated: February 2, 2011
Last verified: January 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
| HIV Infection | Biological: Hepavax-Gene | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Chiang Mai University:
Primary Outcome Measures:
- Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at day 210 [ Time Frame: Day 210 ]
- 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)
- 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:
- 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.
- 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
| Estimated Enrollment: | 132 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289106
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 |
| Study First Received: | February 1, 2011 |
| Last Updated: | February 2, 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 Hepatitis B HIV Infections Liver Diseases Digestive System Diseases Hepadnaviridae Infections DNA Virus Infections Virus Diseases |
Hepatitis, Viral, Human Lentivirus Infections Retroviridae Infections RNA Virus Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on June 21, 2017