Optimizing Vaccine Responsiveness in HIV-1 and HCV Infections by Identifying Determinants of Responsiveness: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 21
- 主要终点
- B-cell humoral responses
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
B-cell humoral responses
时间窗: At Week 8
T-cell responses as reflected by hepatitis B and tetanus antibody titers
时间窗: At Week 8
Dendritic cell, B-cell, and T-cell functional markers
时间窗: At Study Entry
次要结局
- B-cell functional marker(At Week 6)
- 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)
- CD4/CD8 and HCV genotype(At Study entry)
- Baseline antibody status for hepatitis B core antigen (anti-HBc)(At Study entry)