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.
Individuals with HCV and HIV coinfection are especially hard to treat, and as a result, account for a high rate of deaths each year. Because HCV and HIV share transmission routes, HCV/HIV coinfection is common. Liver disease has emerged as a significant cause of death in individuals coinfected with HCV and HIV. Currently, the mechanisms by which HCV and HIV interact in HCV/HIV-coinfected individuals, including how these infections affect immune responses, are poorly understood. Research suggests that vaccination may prevent other comorbidities associated with HCV/HIV coinfection; however, responses to new vaccine antigens have been shown to be impaired in HCV or HIV-infected individuals. The purpose of this study is to identify the innate and adaptive immune defects present in HCV-infected, HIV-infected, and HCV/HIV-coinfected individuals. This study will evaluate whether these innate and adaptive immune defects predict responses to HBV neoantigen in the form of both a diphtheria/tetanus toxoid immunization (Decavac)and a hepatitis A-hepatitis B immunization (Twinrix). This study will last approximately 24 weeks. Participants will be stratified to one of three arms, based on their HCV and HIV status: * Arm A will enroll HCV-infected individuals who are HIV-uninfected * Arm B will enroll HIV-infected individuals who are HCV-uninfected * Arm C will enroll HCV/HIV-coinfected individuals Arms B and C will open for enrollment before Arm A. Opening of enrollment for Arm A will be determined by the accrual progress of Arms B and C as evaluated by the ACTG Scientific Agenda Steering committee. All participants will receive Decavac vaccination on Day 0, and a Twinrix vaccination on Days 0, 7, and 21. Study visits will occur around Days 0, 7, and 21, and at Weeks 6, 8, 12, and 24; all visits will include medical and medication history, blood collection, and a physical exam. Medication to treat HCV or HIV will not be provided by the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
29
UCSD Antiviral Research Center CRS
San Diego, California, United States
Ucsf Aids Crs
San Francisco, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
B-cell humoral responses
Time frame: At Week 8
T-cell responses as reflected by hepatitis B and tetanus antibody titers
Time frame: At Week 8
Dendritic cell, B-cell, and T-cell functional markers
Time frame: At Study Entry
B-cell functional marker
Time frame: At Week 6
T-cell responses to hepatitis A, hepatitis B, and tetanus antigens
Time frame: At Weeks 3 and 8
Longitudinal serum antibody titers to hepatitis A, hepatitis B, and tetanus (B-cell responses)
Time frame: At Study Entry and Weeks 1, 3, 6, 8, 12, and 24
CD4/CD8 and HCV genotype
Time frame: At Study entry
Baseline antibody status for hepatitis B core antigen (anti-HBc)
Time frame: At Study entry
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IHV Baltimore Treatment CRS
Baltimore, Maryland, United States
Massachusetts General Hospital Clinical Research Site (MGH CRS) CRS
Boston, Massachusetts, United States
Columbia P&S CRS
New York, New York, United States
Duke Univ. Med. Ctr. Adult CRS
Durham, North Carolina, United States
Case CRS
Cleveland, Ohio, United States
MetroHealth CRS
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
...and 2 more locations