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

 1. The role of CD4-cell count and HIV viral loads on the HBV vaccine response.

 2. 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.
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:

 1. Those who have received less than 3 months treatment, or no treatment, with highly
 active antiretroviral drugs (HAART naive).

 2. 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.
Inclusion Criteria:

 1. Hepatitis B core antibody (anti-HBc) and anti-HBs negative

 2. Age ≥18 years

 3. 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%.

 4. Ambulatory

 5. Intention to attend the Mulago HIV/AIDS clinic for the 18 months

 6. Able and willing to comply with study protocol including providing informed consent

 Exclusion Criteria:

 1. History of hypersensitivity to vaccines or intolerance to any of the HBV vaccine
 components

 2. Previously-confirmed diagnosis of decompensated liver disease or HCC

 3. Serological evidence of prior receipt of the HBV vaccine (anti-HBS positive, anti-HBc
 negative) or documented (clinical) evidence of having been vaccinated.

 4. Known history of HBV infection (HBsAg and/or anti-HBc positive).

 5. Inability to follow study procedures

 6. If a participant chooses not to consent to the review of his or her medical records