Phase 3b Multicenter, Randomized, Placebo-Controlled, Double-Blind Study Evaluating Immunogenicity and Safety of a 3rd and 4th Dose of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults With End-Stage Renal Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- serotype-specific antibody concentrations
研究概览
简要总结
This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving a 3rd and 4th dose to a subset of the participants in the previous efficacy trial. Participants continue to receive the vaccine or placebo in a blinded manner, and are also randomly assigned to 1 of 2 different intervals between the doses. The immunogenicity is measured by the antibodies in the blood, and typical vaccine safety information is also collected.
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
- 否
入选标准
- •Participation in prior study Nabi-1371
- •Written informed consent
- •Negative serum pregnancy test, where appropriate
- •Expect to comply with protocol procedures and schedule
排除标准
- •Known HIV
- •Immunomodulatory drugs
- •Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)
- •Active infection in the 2 weeks prior to study injection
- •Serious S. aureus infection within the last 2 months prior to injection
- •Hypersensitivity to components of StaphVAX
研究组 & 干预措施
vaccine, schedule 1
3rd and 4th dose of vaccine, on original schedule
干预措施: Staph aureus types 5 and 8 conjugate vaccine (Biological)
vaccine, schedule 2
3rd and 4th dose of vaccine on modified schedule
干预措施: Staph aureus types 5 and 8 conjugate vaccine (Biological)
placebo, schedule 1
3rd and 4th dose of placebo, on original schedule
干预措施: placebo (Biological)
placebo, schedule 2
3rd and 4th dose of placebo on modified schedule
干预措施: placebo (Biological)
结局指标
主要结局
serotype-specific antibody concentrations
时间窗: 6 weeks after each dose
次要结局
- serotype-specific antibody concentrations(at several other time points up to 12 months after dose)
- elicited vaccine reactogenicity(daily for 7 days after each dose)