PNEUMOCELL - Conjugated Pneumococcal Vaccination in Patients With Immunoglobulin G-deficiency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in opsonophagocytic antibodies
研究概览
简要总结
The aim is to study the immune response to conjugated pneumococcal vaccination (Prevenar13) in Immunoglobulin G-deficient patients and healthy controls. Our hypothesis is that the antibody response will be impaired in patients as compared with controls. In contrast, we postulate that the cellular immune response will be intact.
详细描述
Ten patients with Immunoglobulin G1 and/or Immunoglobulin G2 deficiency will be enrolled together with 10 age and sex- matched controls. Blood-samples will be drawn at base-line and after 1, 2 and 4 weeks post-vaccination. Serum will be analyzed for opsonophagocytic antibodies. Peripheral blood monocytic cells (PBMCs) will be isolated, frozen and later analyzed for all time-points simultaneously. PBMCs will be stimulated with vaccine-antigens for 3-5 days and cellular activation markers will be measured together with cytokines (Interferon-gamma, Interleukin (IL)-5, IL-13, IL-10, IL-17, IL-22). In addition, levels of antimicrobial peptides in nasal fluid will be measured at baseline and after 4 weeks post-vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Immunoglobulin gamma-deficiency: Immunoglobulin gamma 1-deficiency < 2,8 g/L and/or Immunoglobulin gamma 2-deficiency < 1,15 g/L
- •Age 18-65
排除标准
- •Immunoglobulin gamma-substitution for 6 months prior to study inclusion
- •Prevenar7 or Prevenar13 given prior to study inclusion.
- •Pneumovax given during a 2 year period prior to study inclusion
- •Pregnancy or planning to become pregnant during the study period (4 weeks)
- •Taking part in another clinical study involving drugs or vaccinations during the study period (4 weeks).
- •Taking systemic steroids, Non steroidal anti inflammatory drugs (NSAID) or immunosuppressive drugs.
- •Being allergic to any substance in the vaccine.
- •Acute and ongoing disease with high fever.
- •Thrombocytopenia (< 100x109/L).
- •Coagulopathy
- •Breastfeeding a baby
- •The healthy controls should not have any disease with effects on the immune-system
结局指标
主要结局
Change in opsonophagocytic antibodies
时间窗: 4 weeks post-vaccination, change from baseline
Titers of opsonophagocytic antibodies will be measured at baseline and 4 weeks post-vaccination. Titers from 4 weeks post-vaccination will be compared with baseline-levels.
次要结局
- Change in cellular immunity(4 weeks post-vaccination, change from baseline)
- Change in antimicrobial peptides(4 weeks post-vaccination, change from baseline)
研究者
Peter Bergman
Associate Professor
Karolinska University Hospital