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
1 other identifier
interventional
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFebruary 3, 2011
January 1, 2011
9 months
February 1, 2011
February 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seroconversion rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 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 Outcomes (2)
Seroprotective rate (percentage of subjects with anti-HBs antibody titer >= 10 IU/L) at 1 year
1 year
Number of subjects with adverse events after vaccination
180 days
Study Arms (3)
Arm A
ACTIVE COMPARATOR20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
Arm B
EXPERIMENTAL20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Arm C
EXPERIMENTAL40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
Interventions
20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Muang, Chiang Mai, 50200, Thailand
Related Publications (3)
Chaiwarith R, Praparattanapan J, Kotarathititum W, Wipasa J, Chaiklang K, Supparatpinyo K. Higher rate of long-term serologic response of four double doses vs. standard doses of hepatitis B vaccination in HIV-infected adults: 4-year follow-up of a randomised controlled trial. AIDS Res Ther. 2019 Nov 11;16(1):33. doi: 10.1186/s12981-019-0249-8.
PMID: 31711528DERIVEDChawansuntati K, Chaiklang K, Chaiwarith R, Praparattanapan J, Supparatpinyo K, Wipasa J. Hepatitis B Vaccination Induced TNF-alpha- and IL-2-Producing T Cell Responses in HIV- Healthy Individuals Higher than in HIV+ Individuals Who Received the Same Vaccination Regimen. J Immunol Res. 2018 Feb 27;2018:8350862. doi: 10.1155/2018/8350862. eCollection 2018.
PMID: 29682590DERIVEDChaiklang 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.
PMID: 24265819DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kanokporn Chaiklang, MD
Faculty of Medicine, Chiang Mai University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 1, 2011
First Posted
February 3, 2011
Study Start
January 1, 2011
Primary Completion
October 1, 2011
Study Completion
April 1, 2012
Last Updated
February 3, 2011
Record last verified: 2011-01