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临床试验/NCT02515240
NCT02515240已完成早期 1 期

Immune Response to Pneumococcal Vaccination in HIV Infected Individuals

University of Toledo Health Science Campus2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2010年7月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
124
试验地点
2
主要终点
Antibody activity and response by opsonophagocytic assay (OPT) and ELISA (ug/ml)

研究概览

简要总结

The purpose of the study. To characterize the immune response to the pneumococcal vaccine in HIV positive individuals and to dissect the most appropriate timing and frequency of vaccination.

详细描述

All potential study candidates will be asked to fill out a questionnaire concerning their medical history and medications. This survey will determine eligibility. If eligible, as part of the experimental protocol the HIV positive participants will agree to be randomized to immediate vs. delayed pneumococcal immunization and 3 blood draws around the time of immunization. The HIV negative control population will agree to immunization with pneumococcal polysaccharide vaccine (PPV), not standard of care for this population, and 3 blood draws around the time of immunization. The investigators will study the effect of pneumococcal vaccination in HIV positive adults. At the present time it is recommended that all HIV positive individuals receive the pneumococcal vaccine at the time of diagnosis with those with cluster of differentiation (CD4) count <200 to be vaccinated either immediately or alternatively, treated with highly active antiretroviral therapy (HAART) for 6 months followed by PPV. All patients are recommended to be re-vaccinated at 5 years. This is the standard of care. It is however unclear how the HIV positive patients respond to PPV. In the 1st part of the study, Part I, newly diagnosed HIV positive individuals will be recruited. As standard of care, these individuals will receive the pneumococcal vaccine regardless of their participation in this study. Those that agree to participate in the study will be grouped according to their CD4 count: >500, 200-500 or <200. Those with a CD4 count <200 will be randomly assigned to receive the vaccine immediately or to receive HAART for 6 months prior to vaccination, this is in accordance with the present recommendations, either immediate vaccination or giving HAART for 6 months prior to vaccination is considered acceptable.. Thus ALL HIV positive individuals will receive the vaccine as presently recommended. The HIV positive volunteers agree to (experimental part of the protocol):

  1. Be randomized to either immediate vaccination vs. 6 months after start of HAART if the CD4 count is <200
  2. Donate blood specimens at 3 different times: day 0, day of vaccination: 2 mL, at day 7, 40 mL and at day 28-42 a one time sample of 2 mL.
  3. Have their blood samples subjected to antibody analysis (concentration and functional activity) and antibody gene usage analysis There will be 4 HIV positive groups in this part of the study: CD4>500, CD4 200-500, CD4 < 200 immediate vaccination and CD4 <200, delayed vaccination.

There will be 19 individuals per group. The HIV negative controls in Part I of the study (n=19) who agree to participate will also be vaccinated with the pneumococcal vaccine. This is NOT a vaccine recommended for healthy adults but is NOT contra-indicated.

Thus as part of the experimental procedure for these individuals they will:

  1. Receive the FDA approved pneumococcal vaccine
  2. Blood samples will be obtained at day 0: 2 mL, day 7 40 mL and day 28-42, one time sample of 2 mL.
  3. Blood samples will be analyzed for antibody concentration, functional activity and gene family usage.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • HIV negative:
  • never immunized with PPV23
  • HIV positive:
  • need for PPV23 per standard of care

排除标准

  • steroid use
  • other immunosuppressive agents;
  • pregnancy
  • incapable of completing consent form

结局指标

主要结局

Antibody activity and response by opsonophagocytic assay (OPT) and ELISA (ug/ml)

时间窗: Day 0 and day 30 of vaccination

次要结局

  • Polysaccharide-specific B cell phenotype: percentage naive or memory B cell distribution flow cytometry(Day 0 and Day7 of vaccination)
  • Flow cytometry : percentage cells expressing tumor necrosis factor receptors on surface(Day 0 and Day7 of vaccination)

研究者

发起方
University of Toledo Health Science Campus
申办方类型
Other
责任方
Sponsor

研究点 (2)

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