Immunologic Response of Hepatitis B Vaccine

Study Overview
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Brief Summary
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This study aims to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination booster strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital.

Detailed Description
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This study intended to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital. 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.

Official Title
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Immunologic Response of Hepatitis B Single Dose Versus 3-dose Series in Previously Vaccinated HIV-infected Adults at Maharaj Nakorn Chiang Mai Hospital: A Randomized Controlled Trial

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Document of HIV infection 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: Active opportunistic infection 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Single dose hepatitis B vaccine<br>Single dose of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at entry | Biological: Hepatitis B vaccine<br>* Hepatitis B vaccine (20 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)<br>|
| Active Comparator: Arm B: 3-dose series of hepatitis B vaccine<br>3-dose series of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at month 0, 1, and 6 | Biological: Hepatitis B vaccine<br>* Hepatitis B vaccine (20 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunologic response to single dose versus 3-dose series of HBV vaccination in HIV-infected adults | Immunologic response to single versus 3-dose series of HBV vaccination in HIV-infected adults, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28 | 28 weeks after the first dose of HBV vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anamnestic response at week 4 | Anamnestic response at week 4, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) | 4 weeks after the first dose of HBV vaccination | 
| Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12 | Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12 | 12 months after the first dose of HBV vaccination] | 
| Intensity and frequency of vaccine adverse event (AE) | Intensity and frequency of vaccine adverse event (AE) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV vaccination, immunity