Determining Responses to Two Different Vaccines in HIV and HCV Infected Individuals (NCT00393276) | Clinical Trial Compass
CompletedPhase 1
Determining Responses to Two Different Vaccines in HIV and HCV Infected Individuals
United States29 participantsStarted 2007-08
Plain-language summary
Infection with either HIV or hepatitis C virus (HCV) affects immune system responses. The purpose of this study is to investigate the immune responses to two different vaccine formulations in HIV-infected, HCV-infected, and HCV/HIV- coinfected individuals.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
B-cell humoral responses
Timeframe: At Week 8
2
T-cell responses as reflected by hepatitis B and tetanus antibody titers
Timeframe: At Week 8
3
Dendritic cell, B-cell, and T-cell functional markers
Timeframe: At Study Entry
Trial details
NCT IDNCT00393276
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)