HIV Infections, Hepatitis C
Conditions
Keywords
Treatment Experienced, Treatment Naive, Immunizations
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALTwinrix
Combined hepatitis A and hepatitis B immunization
BIOLOGICALDecavac
Diphtheria and tetanus toxoid vaccine
Sponsors
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| B-cell humoral responses | At Week 8 |
| T-cell responses as reflected by hepatitis B and tetanus antibody titers | At Week 8 |
| Dendritic cell, B-cell, and T-cell functional markers | At Study Entry |
Secondary
| Measure | Time frame |
|---|---|
| CD4/CD8 and HCV genotype | At Study entry |
| B-cell functional marker | At Week 6 |
| Baseline antibody status for hepatitis B core antigen (anti-HBc) | At Study entry |
| T-cell responses to hepatitis A, hepatitis B, and tetanus antigens | At Weeks 3 and 8 |
| Longitudinal serum antibody titers to hepatitis A, hepatitis B, and tetanus (B-cell responses) | At Study Entry and Weeks 1, 3, 6, 8, 12, and 24 |
Countries
Puerto Rico, United States
Outcome results
None listed