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

This is an interventional prevention trial for HIV Infections focused on measuring Treatment Experienced, Treatment Naive, Immunizations Read More

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