Hepatitis B Vaccination in HIV-infected Adults With Low CD4 Cell Counts

Study Overview
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Brief Summary
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This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in HIV-infected adults with low CD4 cell count in northern Thailand.

Detailed Description
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HIV-infected adults with CD4+ cell counts < 200 cells/mm3, undetectable plasma HIV-1 RNA, and negative for all HBV markers were randomly assigned to receive one of these 2 regimens of recombinant hepatitis B vaccine (Centro De Ingenieria Genetica Y Biotecnologia, La Habana, Cuba); 1) 20 μg IM at months 0, 1, and 6 (3-standard doses group), and 2) 20 μg IM at months 0, 1, 2, 6 (4-standard doses group). This study aimed to evaluate the efficacy and safety of these 2 hepatitis B vaccination regimens at month 7 after vaccination.

Official Title
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Comparison of Immunogenicity and Safety of 4 Standard Doses and 3 Standard Doses of Hepatitis B Vaccination in HIV-infected Adults Who Have CD4 < 200 Cells/mm3

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV-infection ≥18 years old Received combination antiretroviral therapy for at least 1 year Had a CD4+ cell count < 200 cells/mm3 for at least 1 year Undetectable plasma HIV-1 RNA for at least 1 year Negative for hepatitis B surface antigen (HBsAg), antibody to hepatitis B surface antigen (anti-HBs), and antibody to hepatitis B core antigen (anti-HBc), Had no history of previous HBV vaccine Negative for antibody to hepatitis C virus (anti-HCV) No active opportunistic infections (at the time of screening) Willing to sign an informed consent Able to return for follow-up. Exclusion criteria Pregnancy or lactation History of hypersensitivity to any component of the vaccine Active malignancy receiving chemotherapy or radiation, or other immunocompromised conditions besides HIV (e.g., solid organ transplant), received immunosuppressive (e.g., corticosteroid ≥ 0.5 mg/kg/day) or immunomodulating treatment in the last six months before screening visit Renal insufficiency (creatinine clearance <30 mL/min) Decompensated cirrhosis (Child-Pugh class C)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Active Comparator: HIV-Group 1<br>Receiving three intramuscular injections of 20 µg of recombinant hepatitis B vaccine [(CIGB) La Habana, Cuba] at months 0, 1, and 6 | Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]<br>* Different HBV vaccine regimen in each group<br>|
| Experimental: HIV-Group 2<br>Receiving four intramuscular injections of 20 µg of recombinant hepatitis B vaccine [(CIGB) La Habana, Cuba] at months 0, 1, 2, and 6 | Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]<br>* Different HBV vaccine regimen in each group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with protective immunity against HBV | comparison of proportion of participants who had protective immunity (anti-HBS titer >=10 mIU/ml) against HBV between HIV group 2 v.s. HIV group 1 | 1 month after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The geometric means of anti-HBs titers | Comparison of the geometric means of anti-HBS titers between HIV group 2 v.s. HIV group 1 | 1 month after vaccination | 
| Proportion of participants with high level of immune response against HBV | Comparison of proportion of participants who had anti-HBS titers >= 100 mIU/ml between HIV group 2 v.s. HIV group 1 | 1 month after vaccination | 

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