跳至主要内容
临床试验/NCT02806284
NCT02806284已完成2 期

Pneumococci and Hib Vaccination Early and Late After Neurotrauma or Neurosurgery

Uppsala University0 个研究点目标入组 85 人开始时间: 2001年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
85
主要终点
Change from baseline of IgG anti-Hib (ug/ml)

研究概览

简要总结

The purpose of this study is to determine wether skull trauma or neurosurgery affect the immune response to two vaccine types.

详细描述

There is a risk of meningitis after neurotrauma and different actions have been taken to reduce this risk. Prophylactic antibiotics are often administered, although at present there is little evidence to support such a regimen. Increasing problems with antibiotic resistance heightens the need for pertinent use of antibiotics.

Even if most of these infections occur early in the course, the risk appears to persist for many years and almost half of the posttraumatic meningitis cases occur after one month. Streptococcus pneumoniae is the most common causative agent and pneumococcal vaccination after neurotrauma is now recommended in several national guidelines. There are, however, no recommendations of when to administer the vaccine. In clinical practice, vaccination is most often performed several weeks after the trauma. Because the risk of meningitis is at the highest shortly after the trauma, vaccination within days would be preferable. Until recently, pneumococcal polysaccharide vaccine (PPSV) was the most common recommendation. During recent years pneumococcal conjugate vaccines (PCV) have been introduced, offering long-term protection and is now recommended in the USA.

Trauma, as well as surgery, activate the innate immune system resulting in, among other things, decreased T-cell function. Patients with injuries of the central nervous system (CNS) may show signs of a specific CNS-injury-induced immune deficiency syndrome (CIDS), which is also characterized by impaired T-cell activity. Accordingly, it can be speculated that ongoing anti-inflammatory response after trauma, here referred to as trauma-induced immune deficiency syndrome (TIDS), and CIDS by impaired T-cell function could negatively affect the response to vaccines, especially to T-cell dependent conjugate vaccines. In the present thesis, focus will be the impact of TIDS and CIDS on the response to T-cell dependent and T-cell independent vaccines.

Methods

Vaccination A conjugate vaccine against Haemophilus influenzae type b (Hib) was chosen as the T-cell-dependent antigen. All patients received a single subcutaneous injection of 0.5 ml Act-HIB® (Sanofi Pasteur MSD, Lyon, France) in the upper right arm. A 0.5 ml dose of this vaccine contains 10 μg of Hib polysaccharide conjugated to 24 micrograms of tetanus protein.

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
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Basilar skull fracture or transsphenoidal pituitary gland surgery
  • Own or presumed consent (by next of kin of unconscious)

排除标准

  • 未提供

结局指标

主要结局

Change from baseline of IgG anti-Hib (ug/ml)

时间窗: baseline and 6 weeks

Change from baseline of specific IgG against pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (ug/ml)

时间窗: baseline and 6 weeks

次要结局

未报告次要终点

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

相似试验

Pneumococci and Hib Vaccination After Neurotrauma or... | 临床试验