Pneumococcal Conjugate Vaccine (Prevnar; Wyeth) With Pneumococcal Polysaccharide Vaccine (23-valent) and Tetanus/Diphtheria Vaccine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- ELISA for S. pneumoniae antibody 2 months after receiving PPV23
研究概览
简要总结
The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination ("tetanus shot") before giving pneumococcal vaccine makes the pneumococcal vaccine more effective without causing too many side effects.
详细描述
The only vaccine licensed in the United States for protecting adults against pneumococcal disease (PPV23) protects against invasive disease in observational studies but has generally been poorly effective against pneumonia or all-cause mortality in randomized clinical trials. Another vaccine containing seven polysaccharide antigens conjugated to diphtheria toxoid (PCV7) is licensed for children and under investigation in adults.
In this pilot study, we are comparing the safety and immunogenicity of three immunization schedules in adults:
- Td vaccine, 2-week interval, PCV7, 4-month interval, PPV23
- PCV7, 4-month interval, PPV23
- PPV23
We aim to:
- compare the safety profiles of pneumococcal vaccines given on each of the three schedules
- compare serotype-specific ELISA antibody response to pneumococcal antigens given on each of the three schedules
- compare functional serotype-specific antibody responses to pneumococcal antigens given on each of the three schedules
- study the influence of diphtheria antibody levels at the time of pneumococcal conjugate vaccine administration on the magnitude of the immune response to pneumococcal antigens
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Exclusion Criteria:
- •Participation in any other investigational clinical trials except purely observational studies within 4 weeks prior to study start
- •Any vaccination within 2 weeks prior to first study vaccine
- •Evidence of systemic or local infection within one week prior to first study vaccine
- •HIV infection
- •Renal failure
- •Receipt of a pneumococcal or Td vaccine within 5 years
- •Current receipt of therapy for neoplastic disease
- •Current receipt of immunosuppressive therapy
- •Terminal illness withlife expectancy less than 3 months
排除标准
- •Participation in any other investigational clinical trials except purely observational studies within 4 weeks prior to study start
- •Any vaccination within 2 weeks prior to first study vaccine
- •Evidence of systemic or local infection within one week prior to first study vaccine
- •HIV infection
- •Renal failure
- •Receipt of a pneumococcal or Td vaccine within 5 years
- •Current receipt of therapy for neoplastic disease
- •Current receipt of immunosuppressive therapy
- •Terminal illness withlife expectancy less than 3 months
结局指标
主要结局
ELISA for S. pneumoniae antibody 2 months after receiving PPV23
Functional S. pneumoniae antibody 2 months after receiving PPV23
次要结局
- Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination