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临床试验/NCT00211913
NCT00211913已完成3 期

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Undergoing Cardiovascular Surgery

Nabi Biopharmaceuticals2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2004年6月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
120
试验地点
2
主要终点
Serotype-specific antibody concentrations

研究概览

简要总结

S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and during the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for cardiovascular surgery.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Candidate for cardiovascular surgery
  • Expected to comply with protocol
  • Negative pregnancy test where appropriate
  • Written informed consent

排除标准

  • Known S. aureus infection in past 3 months
  • Known infection in the past 2 weeks
  • Known HIV infection
  • Pregnancy or breast-feeding
  • Immunomodulatory drugs
  • Malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer
  • investigational drugs, vaccines or products in the past 30 days
  • Hypersensitivity to components of StaphVAX

结局指标

主要结局

Serotype-specific antibody concentrations

时间窗: 6 weeks after the vaccine dose

次要结局

  • adverse events(0-180 days after vaccine dose)
  • Serotype-specific antibody concentrations(at other time points 7-180 days after the vaccine dose.)

研究者

申办方类型
Industry

研究点 (2)

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