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

NCT ID: NCT00164411

Last Updated: 2012-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-03-31

Brief 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.

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

Conditions

Pneumococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Tetanus-diphtheria toxoids (Td)

Intervention Type: BIOLOGICAL

7-valent pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

23-valent polysaccharide vaccine

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Principal Investigators

Harry L Keyserling, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University School of Medicine

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

CDC-NIP-3669

Identifier Type: -

Identifier Source: org_study_id