Novel Serotype Alert: Investigate New Pneumococcal Conjugate Vaccines for Inducing Cross-protection Against Newly Discovered Serotype 33E and Putative Novel Serogroup 33 Serotypes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Serogroup 33 antibodies
研究概览
简要总结
The goal of this study is to learn whether different types of vaccines to prevent bacterial infections are able to effectively create antibodies that defend against certain types of bacteria.
We will give two different types of vaccine and evaluate the effectiveness of antibodies produced by each vaccine in killing bacteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Healthy adult
排除标准
- •No prior history of pneumococcal vaccination
- •No immunosuppressing medications or chronic diseases that affect immune function
研究组 & 干预措施
PCV21
Will receive PCV21
干预措施: Pneumococcal Vaccine (Biological)
PCV20
Will receive PCV20
干预措施: Pneumococcal Vaccine (Biological)
结局指标
主要结局
Serogroup 33 antibodies
时间窗: 4 weeks post-vaccination
Serum antipneumococcal antibody concentrations (micrograms/mL) against members of serogroup 33, measured using WHO-ELISA
Antibody-mediated killing
时间窗: 4 weeks post-vaccination
Opsonic activity of vaccine-induced antibodies (reported as opsonic index, or OI); measured using an opsonophagocytic killing (OPK) assay.
Serogroup 33 antibodies
时间窗: 4 weeks post-vaccination
Serum antipneumococcal antibody concentrations (micrograms/mL) against members of serogroup 33, measured using WHO-ELISA
Antibody-mediated killing
时间窗: 4 weeks post-vaccination
Opsonic activity of vaccine-induced antibodies (reported as opsonic index, or OI); measured using an opsonophagocytic killing (OPK) assay.
次要结局
未报告次要终点
研究者
David Lafon
Assistant Professor
University of Alabama at Birmingham