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

22:11 EDT 2nd September 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

Clinical Trials [1263 Associated Clinical Trials listed on BioPortfolio]

Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine Administered to Infants in Korea

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate va...

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

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomita...

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.

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomita...

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants

The purpose of this study will be to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy infants given with routine pediatric vaccin...

PubMed Articles [2016 Associated PubMed Articles listed on BioPortfolio]

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...

Revaccination with 7-valent pneumococcal conjugate vaccine elicits better serologic response than 23-valent pneumococcal polysaccharide vaccine in HIV-infected adult patients who have undergone primary vaccination with 23-valent pneumococcal polysaccharide vaccine in the era of combination antiretroviral therapy.

HIV-infected adults who had received 23-valent pneumococcal polysaccharide vaccine (PPV23) five years or more earlier consecutively underwent revaccination with one dose of PPV23 (127 subjects) from D...

Reduction of invasive pneumococcal disease three years after the introduction of the 13 valent conjugate vaccine in the Oxfordshire region, England.

Background. The 7-valent pneumococcal conjugate (PCV7) vaccine's impact on invasive pneumococcal disease (IPD) is well described, but few reports exist on the additional impact of the 13-valent vacc...

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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A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...

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