A Phase 1 Randomized, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (SPWCV+Alum) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Unsolicited Adverse Event Reports
研究概览
简要总结
The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •, Healthy adults:
- •If female, not breastfeeding, not pregnant, not planning pregnancy during study period), and willing to consistently use an adequate method of contraception and have repeated pregnancy tests.
- •In good health with normal laboratory results
- •Willing to comply with study restrictions, study schedule, and can be reliably contacted
排除标准
- •Currently consumes alcohol in excess of 2 drinks per day for men or 1 drink per day for women.
- •current use or likely requirement for medications with potential for liver injury or effect immune system
- •History of event or condition such as anaphylaxis, severe allergic reactions, serious reactions to any vaccines, or other events that might increase risk of reaction to an investigational disease
- •History of diabetes, cancer, autoimmune or immunosuppressive disease or chronic such as HIV, Hepatitis B or C
研究组 & 干预措施
Cohort 1 SPWCV+Alum 100 mcg
each individual receiving 3 vaccinations of same dose 28 days apart
干预措施: SPWCV+Alum 100 mcg (Biological)
Cohort 2 SPWCV+Alum 300 mcg
each individual receiving 3 vaccinations of same dose 28 days apart
干预措施: SPWCV+Alum 300 mcg (Biological)
Cohort 3 SPWCV+Alum 600 mcg
each individual receiving 3 vaccinations of same dose 28 days apart
干预措施: SPWCV+Alum 600 mcg (Biological)
Normal Saline Injection
placebo group within each cohort receive 3 injections of normal saline 28 days apart
normal saline injection: 3 cohorts of normal saline injection
干预措施: Placebo (Other)
结局指标
主要结局
Unsolicited Adverse Event Reports
时间窗: within 1 week (0-7 days) following each vaccinations
Safety and Tolerability assessed by cohort and product received measured by: •Number of unsolicited AEs within four weeks after each vaccination
次要结局
- Immunogenicity Determined by the Number of Subjects With >4x Increase in Anti IgG(28, 56 and 84 days following initial vaccination)