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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Biological: Hepavax-Gene | Phase 3 |
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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Arm A
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
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Biological: Hepavax-Gene
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
Other Name: Berna
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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
|
- 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
- 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

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

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
Contact: Kanokporn Chaiklang, MD | +66 89 8539864 | kanokpornk@rihes.org |
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 |
Principal Investigator: | Kanokporn Chaiklang, MD | Faculty of Medicine, Chiang Mai University |
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 |