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

Pneumococcal Infections Clinical Trial

Official title:

Pneumococcal Conjugate Vaccine (Prevnar; Wyeth) With Pneumococcal Polysaccharide Vaccine (23-valent) and Tetanus/Diphtheria Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164411
• Other study ID #: CDC-NIP-3669
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: March 13, 2012
• Start date: January 2004
• Est. completion date: March 2005

Study information

• Verified date: March 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pneumococcal Infections

Intervention

Biological:
• Tetanus-diphtheria toxoids (Td)

• 7-valent pneumococcal conjugate vaccine

• 23-valent polysaccharide vaccine

Locations

Country	Name	City	State
United States	Emory University School of Medicine	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ELISA for S. pneumoniae antibody 2 months after receiving PPV23
Primary	Functional S. pneumoniae antibody 2 months after receiving PPV23
Secondary	Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination