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
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
- 是
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.)
