Impact of HIV-1 and Aging on Mucosal Vaccine Responses
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Determine pneumococcal specific IgG levels in serum
研究概览
简要总结
The purpose of this study is to learn more about both HIV-1 infection and advancing age, and their association with increased risk of serious infection and impaired response to the Prevnar 13 vaccine.
详细描述
After being informed about the study and potential risks, patients will be screened to determine eligibility for the study and consented. Patients who meet eligibility requirements will be immunized with PCV 20. HIV-infected adults will be tested prior to and after vaccination by blood, nasal filter paper, and stool samples to characterize mucosal and systemic antibody responses . HIV-uninfected control adults will be tested at vaccination and post vaccination to characterize mucosal and systemic antibody responses .
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
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
Participants with be given a screening number and a participant number as a unique identifier that does not involve their name.
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Veterans only (accessibility to non-veterans pending)
- •Age 21-45 or 55-75 Years Old
- •Have not received pneumococcal vaccine Prevnar PCV-13
- •Able to attend 2-3 study visits over 1 month
- •Undetectable Viral load
- •HIV negative controls:
- •no history or risks for HIV infection
排除标准
- •Spleen removed
- •Chronic Kidney disease (creatinine ≥ 2.0 mg/dL)
- •Active liver disease
- •Currently taking: Corticosteroids (prednisone, medrol, etc), Chemotherapy, Immunosuppressive medication (cyclosporine, methotrexate, azathioprine, infliximab, adalimumab, rituximab, etanercept, etc), or illicit drugs (methamphetamine, cocaine, crack, or heroin)
研究组 & 干预措施
HIV Negative Controls
One time administration of Prevnar-13 vaccine to HIV Negative Control participants
干预措施: Prevnar-13 (Biological)
HIV+
One time administration of Prevnar-13 vaccine to HIV+ participants
干预措施: Prevnar-13 (Biological)
结局指标
主要结局
Determine pneumococcal specific IgG levels in serum
时间窗: A change from baseline, measured at pre-vaccination, and 1 month post vaccine
Determine pneumococcal specific IgG levels in serum 1 month post vaccination response criteria must meet \>2-fold rise with a post-vaccination level \>1000 ng/ml for \> 7 of the 12 serotypes
Determine pneumococcal specific IgG levels in BAL (BronchoAlveolar Lavage) fluid and NPF (Nasopharyngeal Fluid)
时间窗: A change from baseline, measured at pre-vaccination, and 1 month post vaccine
Determine pneumococcal specific IgG levels in BAL fluid and NPF and to standardize the results we will compare it to the total levels in the BAL/NPF fluid collected at all timepoints
次要结局
未报告次要终点