Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in Uganda

Study Overview
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Brief Summary
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The aim of this study is to compare the effectiveness of two vaccination strategies against Hepatitis B virus (HBV) in subjects already infected with human immunodeficiency virus (HIV). Researchers plan to determine the optimal vaccination strategy for achieving protective immunity to HBV infection in HIV-infected adults attending Mulago Hospital's HIV care clinic. Primary objectives are to assess: The role of CD4-cell count and HIV viral loads on the HBV vaccine response. The role of highly active antiretroviral therapy (HAART) on the HBV vaccine response. The secondary objective is to evaluate whether lack of HAART is associated with high rates of loss to follow-up.

Detailed Description
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This is an interventional study in which researchers will recruit HIV positive individuals who do not have hepatitis B (HBV negative) in order to assess the effectiveness of a hepatitis B vaccine in 2 subgroups: Those who have received less than 3 months treatment, or no treatment, with highly active antiretroviral drugs (HAART naive). Those who have received at least 3 months of treatment with highly active antiretroviral drugs (HAART exposed). All study participants will receive vaccination against HBV. There will be 6-12 clinic visits depending on 1) whether or not the participant responds to the standard 3-dose vaccination protocol and 2) whether he or she suffers a clinical condition or vaccine related adverse event that would call for postponement of the next vaccine dose. The first visit will be to determine if the participant is eligible for the study. If eligible, the participant will receive one dose of vaccine at each of the following three visits. The fifth visit will be to collect blood to determine whether the participant has responded to the 3-dose vaccination protocol. The sixth visit will be to discuss the outcome of the vaccination with the participant. Participants who respond favorably to the 3-dose vaccine protocol will exit the study at this point. However, if a participant fails to respond to the initial 3-dose vaccine protocol, he or she may restart the regimen and receive another 3 doses of vaccine following the same schedule as before but off protocol. Participants will be reimbursed for travel costs to and from the clinic for scheduled clinic visits.

Official Title
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Strategies for the Prevention of Hepatitis B Viral Infection Among HIV Infected Adults in Uganda

Conditions
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HIV/AIDS and Infections

Intervention / Treatment
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* Biological: Hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatitis B core antibody (anti-HBc) and anti-HBs negative Age ≥18 years HIV infected persons (HAART naïve and HAART exposed). HAART enrollees will be considered to be HAART exposed if they have been taking these medications for at least 3 months. Participants that have never been on HAART and those that have been on HAART for <3months will be considered to be HAART naïve. HAART exposed enrollees will have an adherence of at least 95%. Ambulatory Intention to attend the Mulago HIV/AIDS clinic for the 18 months Able and willing to comply with study protocol including providing informed consent Exclusion Criteria: History of hypersensitivity to vaccines or intolerance to any of the HBV vaccine components Previously-confirmed diagnosis of decompensated liver disease or HCC Serological evidence of prior receipt of the HBV vaccine (anti-HBS positive, anti-HBc negative) or documented (clinical) evidence of having been vaccinated. Known history of HBV infection (HBsAg and/or anti-HBc positive). Inability to follow study procedures If a participant chooses not to consent to the review of his or her medical records

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HAART exposed<br>Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description | Biological: Hepatitis B vaccine<br>* An eligible participant will receive 3 doses of hepatitis B vaccine ( 20mcg in the deltoid intramuscular). Then their immune response will be assessed. Non responders will receive 3 additional vaccine doses off protocol<br>* Other names: Euvax B (Sonafi);|
| Other: HAART naive<br>Participants in both arms will receive the Hepatitis B vaccine as summarized in the study description | Biological: Hepatitis B vaccine<br>* An eligible participant will receive 3 doses of hepatitis B vaccine ( 20mcg in the deltoid intramuscular). Then their immune response will be assessed. Non responders will receive 3 additional vaccine doses off protocol<br>* Other names: Euvax B (Sonafi);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis B virus (HBV) vaccine response | Measure Hepatitis B surface antibody (anti-HBs) levels and cell mediated immune response. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss to follow-up (HAART naive vs. HAART exposed individuals) | Compare the number of individuals lost to follow-up among the HAART naive and HAART exposed. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B vaccine HIV infection