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

This study has been completed.
Sponsor:
Collaborator:
Emory University
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164411
First received: September 9, 2005
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Pneumococcal Infections
Biological: Tetanus-diphtheria toxoids (Td)
Biological: 7-valent pneumococcal conjugate vaccine
Biological: 23-valent polysaccharide vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pneumococcal Conjugate Vaccine (Prevnar; Wyeth) With Pneumococcal Polysaccharide Vaccine (23-valent) and Tetanus/Diphtheria Vaccine

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • ELISA for S. pneumoniae antibody 2 months after receiving PPV23
  • Functional S. pneumoniae antibody 2 months after receiving PPV23

Secondary Outcome Measures:
  • Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination

Estimated Enrollment: 30
Study Start Date: January 2004
Estimated Study Completion Date: March 2005
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
  Eligibility

Ages Eligible for Study:   50 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164411

Locations
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Harry L Keyserling, MD Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00164411     History of Changes
Other Study ID Numbers: CDC-NIP-3669
Study First Received: September 9, 2005
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:
Diptheria-Tetanus vaccine
Pneumococcal vaccine
Adverse events following vaccination
Immunization
Immunogenicity

Additional relevant MeSH terms:
Diphtheria
Pneumococcal Infections
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Streptococcal Infections

ClinicalTrials.gov processed this record on September 29, 2014