Pneumococcal Infections Clinical Trial
Official title:
Pneumococcal Conjugate Vaccine (Prevnar; Wyeth) With Pneumococcal Polysaccharide Vaccine (23-valent) and Tetanus/Diphtheria Vaccine
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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