Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine
March 13, 2012 updated by: Centers for Disease Control and Prevention
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.
Study Overview
Status
Completed
Conditions
Detailed 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 Type
Interventional
Enrollment
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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ELISA for S. pneumoniae antibody 2 months after receiving PPV23
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Functional S. pneumoniae antibody 2 months after receiving PPV23
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Secondary Outcome Measures
Outcome Measure |
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Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Harry L Keyserling, MD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
March 14, 2012
Last Update Submitted That Met QC Criteria
March 13, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Clostridium Infections
- Corynebacterium Infections
- Pneumococcal Infections
- Tetanus
- Diphtheria
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
- Heptavalent Pneumococcal Conjugate Vaccine
Other Study ID Numbers
- CDC-NIP-3669
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.