Immunogenicity of Repeated Dose 13-valent Pneumococcal Conjugate Vaccine Compared to the Existing Recommended Protocol of Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 4
- 主要终点
- Change from baseline serum serotype specific immunoglobulin G (IgG) antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the first vaccination
研究概览
简要总结
Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant morbidity and mortality in both otherwise healthy adult population and in the immunocompromised patients. The incidence rate of invasive pneumococcal disease is considerably higher among organ transplant patients than in healthy individuals. Routine immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine has been shown to be more immunogenic and safe in some other subgroups of immunocompromised patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •consecutive new kidney or liver transplantation in our center
- •kidney or liver retransplantation in our center
排除标准
- •Age < 18 years
- •Previous Pneumococcal vaccination < 3 years ago
- •Febrile illness at the time of vaccination
- •Any sign of graft failure or rejection at the time of vaccination
- •Splenectomy
- •Pregnancy
- •Critically ill patient due to any cause, including terminal uncompensated liver disease
研究组 & 干预措施
Pneumovax
68 kidney transplant patients vaccinated with Pneumovax as they enter the transplant waiting list, serotype specific ELISA and OPA measured before and after the vaccination. At six and seven months after transplantation ELISA and OPA measured parallel to the experimental group
干预措施: Pneumovax (Biological)
liver Pneumovax
30 liver transplant patients vaccinated with Pneumovax once they enter the transplant waiting list. Serotype specific ELISA and OPA measured pre- and postvaccination. At 6 and 7 months posttransplant ELISA and OPA measured parallel to the experimental group.
干预措施: Pneumovax (Biological)
liver Prevenar13
30 liver transplant patients vaccinated with Prevenar13 once they enter the transplant waiting list. Serotype specific ELISA and OPA measured before and after the vaccination. Revaccinated with Prevenar13 at 6 months after the transplantation. ELISa and OPA measured pre- and postvaccination.
干预措施: Prevenar13 (Biological)
Prevenar13
68 kidney transplant patients vaccinated with Prevenar13 as they enter the transplant waiting list. Pre- and postvaccination serotype specific ELISA and OPA measured. Revaccination at 6 months after the transplantation with Prevenar13, again pre- and postvaccination serotype specific ELISA and OPA measured
干预措施: Prevenar13 (Biological)
结局指标
主要结局
Change from baseline serum serotype specific immunoglobulin G (IgG) antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the first vaccination
时间窗: baseline and 4 weeks after the first vaccination
Change from baseline serum serotype specific IgG antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the second Prevenar vaccination
时间窗: baseline and 4 weeks after the second vaccination
次要结局
- vaccination reactions(from vaccination upto 1 week)
- rejection(at 1 and 2 months after the vaccination)
研究者
Mari Eriksson
MD, doctor of Infectious Diseases
Helsinki University Central Hospital