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

12:53 EDT 24th October 2014 | 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

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Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

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Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

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Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

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PubMed Articles [1980 Associated PubMed Articles listed on BioPortfolio]

Dynamics of pneumococcal carriage among day-care center attendees during the transition from the 7-valent to the higher-valent pneumococcal conjugate vaccines in Greece.

In Greece recently, higher-valent pneumococcal conjugate vaccines (PCVs) replaced the 7-valent (PCV7); the 10-valent (PCV10) became available in May 2009 and the 13-valent (PCV13) in June 2010.

Direct effect of 10-valent conjugate pneumococcal vaccination on pneumococcal carriage in children Brazil.

10-valent conjugate pneumococcal vaccine/PCV10 was introduced in the Brazilian National Immunization Program along the year of 2010. We assessed the direct effectiveness of PCV10 vaccination in preven...

Prevalent Multidrug-resistant Nonvaccine Serotypes in Pneumococcal Carriage of Healthy Korean Children Associated with the Low Coverage of the Seven-valent Pneumococcal Conjugate Vaccine.

Our previous longitudinal multicenter-based carriage study showed that the average carriage rate of Streptococcus pneumoniae was 16.8% in 582 healthy children attending kindergarten or elementary scho...

Impact of 13-Valent Pneumococcal Conjugate Vaccination on Streptococcus pneumoniae Carriage in Young Children in Massachusetts.

In April 2010, a 13-valent pneumococcal conjugate vaccine (PCV13) replaced PCV7 for use in the United States. We evaluated rates of pneumococcal colonization, by serotype and antibiotic resistance, in...

Pediatric Invasive Pneumococcal Disease in Taiwan Following a National Catch-Up Program with the 13-Valent Pneumococcal Conjugate Vaccine.

Seven-valent pneumococcal conjugate vaccine (PCV) has been available in Taiwan since late 2005. A national catch-up program was launched in Taiwan in 2013, providing one dose of 13-valent PCV to child...

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.

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.

Combined vaccines consisting of DIPHTHERIA TOXOID; TETANUS TOXOID; and an acellular form of PERTUSSIS VACCINE. At least five different purified antigens of B. pertussis have been used in various combinations in these vaccines.

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