Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2017-07-01
2018-10-01
Brief Summary
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Detailed Description
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As a part of HBV prevention program, HBV vaccine has been included in Thailand expanded program on immunization (EPI) since 1992. HBV vaccine has been shown to be safe, effective, and has a prolonged protective immunity to HBV infection. Despite the immunity from HBV vaccination could wane overtime, the previous data in general population revealed that HBV vaccine booster could raise the immune in very well. However, the data about booster effects for HBV vaccine among HIV-infected population who previously received a vaccination during their childhood is lagging. Based on previous data of vaccination response in HIV-infected population, the investigators estimate that the protective antibody will rise up to 60% with HBV vaccine one dose booster versus 90% with 3-dose series. Eighty participants, HIV-infected person who were born after HBV vaccine were born after HBV has been included in Thai EPI without evidence of HBV infection nor protective immunity, will be enrolled to this study (with estimation of 5% loss follow up rate). The participants will be randomized in 1:1. The immune response and vaccine safety will be evaluated at 1,7 and 12 months after the first dose HBV vaccine.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm A: Single dose hepatitis B vaccine
Single dose of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at entry
Hepatitis B vaccine
Hepatitis B vaccine (20 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)
Arm B: 3-dose series of hepatitis B vaccine
3-dose series of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at month 0, 1, and 6
Hepatitis B vaccine
Hepatitis B vaccine (20 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)
Interventions
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Hepatitis B vaccine
Hepatitis B vaccine (20 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)
Eligibility Criteria
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Inclusion Criteria
* Thai nationality
* Age ≥18 years old
* Born after 1 January 1992
* Has been taking antiretroviral drugs for HIV treatment
* CD4 ≥200 cell/mm3 and VL \<50 copies/mL for at least 6 months before enrollment
* Negative for any HBV and HCV serological markers
* Willing to sign informed consent
* Able to follow up
Exclusion Criteria
* Pregnancy or breast feeding
* History of previous hepatitis B vaccine booster
* History of hypersensitivity to any component of vaccine
* Malignancy which received chemotherapy or radiation
* Immunocompromised condition such as solid-organ transplantation, chemotherapy in the last 6 months
* On Immunosuppressive treatment, immunomodulating treatment or general corticotherapy (equal or above 0.5 mg per kg per day )
* Renal failure (creatinine clearance \<30 mL/min)
* Transaminitis in the past 3 months (≥ 5 UNL)
* Decompensated cirrhosis (child-Pugh class C)
* Unable or not willing to return for follow up
18 Years
25 Years
ALL
No
Sponsors
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Chiang Mai University
OTHER
Responsible Party
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Romanee Chaiwarith
Associate Professor
Principal Investigators
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Romanee Chaiwarith, MD
Role: PRINCIPAL_INVESTIGATOR
Chiang Mai University
Locations
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Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai University
Muang, Chiang Mai, Chiang Mai, Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4564
Identifier Type: -
Identifier Source: org_study_id
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