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Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine

2014-07-24 14:28:00 | BioPortfolio

Summary

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.

Description

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

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Pneumococcal Infections

Intervention

Tetanus-diphtheria toxoids (Td), 7-valent pneumococcal conjugate vaccine, 23-valent polysaccharide vaccine

Location

Emory University School of Medicine
Atlanta
Georgia
United States
30322

Status

Active, not recruiting

Source

Centers for Disease Control and Prevention

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:28:00-0400

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A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults

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PubMed Articles [1927 Associated PubMed Articles listed on BioPortfolio]

Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China.

The invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae pose an enormous threat to children under 5 years of age. However, routine use of pneumococcal conjugate vaccines could a...

Post-hoc analysis of a randomized controlled trial: Diabetes mellitus modifies the efficacy of the 13-valent pneumococcal conjugate vaccine in elderly.

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Medical and Biotech [MESH] Definitions

A suspension of killed Bordetella pertussis organisms, used for immunization against pertussis (WHOOPING COUGH). It is generally used in a mixture with diphtheria and tetanus toxoids (DTP). There is an acellular pertussis vaccine prepared from the purified antigenic components of Bordetella pertussis, which causes fewer adverse reactions than whole-cell vaccine and, like the whole-cell vaccine, is generally used in a mixture with diphtheria and tetanus toxoids. (From Dorland, 28th ed)

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

A vaccine consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and whole-cell PERTUSSIS VACCINE. The vaccine protects against diphtheria, tetanus, and whooping cough.

A pneumococcal vaccine which 7 pneumococcal serotypes (6B, 14, 19F, 23F, 18C, 4, 9V), each conjugated individually to the outer membrane protein complex of NEISSERIA MENINGITIDIS.

The formaldehyde-inactivated toxin of Corynebacterium diphtheriae. It is generally used in mixtures with TETANUS TOXOID and PERTUSSIS VACCINE; (DTP); or with tetanus toxoid alone (DT for pediatric use and Td, which contains 5- to 10-fold less diphtheria toxoid, for other use). Diphtheria toxoid is used for the prevention of diphtheria; DIPHTHERIA ANTITOXIN is for treatment.

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