Determining Responses to Two Different Vaccines in HIV and HCV Infected Individuals

Inclusion Criteria for Arm A Participants:

• HCV-infected
• HIV-uninfected

Inclusion Criteria for Arm B Participants:

• HIV-infected
• HCV-uninfected
• CD4 count greater than or equal to 300 cells/mm3 within 60 days prior to study entry

Inclusion Criteria for Arm C Participants:

• HIV-infected
• HCV-infected

Inclusion Criteria for All Participants:

• Documented hepatitis B virus (HBV) antibody status. If anti-HBV core antibody positive, documented HBV negative test within 30 days prior to study entry is required.
• Willing to use acceptable forms of contraception for the duration of the study and for 24 weeks after the last vaccination

Exclusion Criteria for Arm A Participants:

• Concurrent or recent treatment for HCV infection (within the past three months)

Exclusion Criteria for Arm B Participants:

• Current, prior, or clinical need for antiretroviral therapy (within the past three months prior to study entry)
• Opportunistic infection other than HCV

Exclusion Criteria for Arm C Participants:

• Concurrent or recent treatment for HCV infection (within the past three months)
• Current, prior, or clinical need for antiretroviral therapy (within the past three months prior to study entry). More information on this criterion can be found in the protocol.
• Opportunistic infection other than HCV

Exclusion Criteria for All Participants:

• History of exposure to hepatitis A vaccine, hepatitis B vaccine, or combined hepatitis A-hepatitis B vaccines
• Immunomodulatory agents for 7 days or more within 30 days prior to study entry. More information on this criterion can be found in the protocol.
• Concurrent immunizations (e.g., influenza, pneumococcal, other vaccine)within 3 days prior to study entry
• Active or recent (in the last six months prior to study entry) CDC Category C event. More information on this criterion can be found in the protocol
• Systemic anticancer chemotherapy or radiation within 24 weeks prior to study entry, or anticipated need to begin such treatment
• Past or current immunologically-mediated disease. More information on this criterion can be found in the protocol.
• Current bacterial infection requiring treatment, therapy, or hospitalization within 1 week prior to study entry
• Serious illness requiring systemic treatment and/or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
• Current uncontrolled seizure disorders
• Active bleeding varices, or Child's B or C cirrhosis. More information on this criterion can be found in the protocol.
• Serious bleeding disorder that poses a risk to a participant for intramuscular injections
• Known allergy or sensitivity to study vaccines or their formulations
• Current drug or alcohol use that, in the opinion of the investigator, interferes with study participation
• Pregnant or breastfeeding
• Use of systemic investigational agents within 30 days prior to entry
• History of any hepatitis A vaccine within one year