Humoral Determinants of Immunity to Pneumococcal Infection

NCT00304382 | Completed Phase 4

• 2 other identifiers: INDB-013-05FH-16562
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether there are differences in the level of antibody to capsular polysaccharides of S. pneumoniae or the physiological activity of such antibody after vaccinating patients who have recovered from pneumococcal pneumonia with pneumococcal polysaccharide vaccine (Pneumovax) or conjugate pneumococcal vaccine (Prevnar).

Conditions

Pneumonia; Pneumococcal Infections; Infections, Streptococcus Pneumoniae

Keywords

Pneumococcus; Pneumococcal pneumonia

Outcome Measures

Primary Outcomes (1)

• Serum will be used to measure antibody to capsular polysaccharide by ELISA and opsonophagocytic activity

  30 days

Secondary Outcomes (1)

• Serum will be used to measure antibody to capsular polysaccharide by ELISA and opsonophagocytic capacity

  6 months

Study Arms (4)

PPV-PCV

EXPERIMENTAL

Patients receive Pneumovax, and 6 months later Prevnar

Biological: Prevnar; Biological: Pneumovax

PCV-PPV

EXPERIMENTAL

Patients receive Prevnar, and 6 months later Pneumovax

Biological: Prevnar; Biological: Pneumovax

PCV-PCV

EXPERIMENTAL

Patients receive Prevnar, and 6 months later Prevnar again

Biological: Prevnar

PCV only

EXPERIMENTAL

Patients receive Prevnar only

Biological: Prevnar

Interventions

Prevnar BIOLOGICAL

0.5 ml IM into each deltoid muscle one time (or two in group PCV-PCV)

Also known as: Pneumococcal 7-Valent Conjugate Vaccine

PCV only; PCV-PCV; PCV-PPV; PPV-PCV

Pneumovax BIOLOGICAL

0.5 ml IM one time

Also known as: Pneumococcal Vaccine Polyvalent

PCV-PPV; PPV-PCV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of pneumococcal pneumonia
• Age matched controls who have not had pneumococcal pneumonia
• Patients enrolled must be veterans

You may not qualify if:

• Patients who do not have the diagnosis of pneumococcal pneumonia based on a clinical syndrome that is consistent with pneumonia and the finding of pneumococcus in blood or sputum or any other sterile site will be excluded
• Women of child-bearing age will be excluded
• Patients who have had a prior reaction to pneumococcal vaccine that they describe as 'severe' will be excluded

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Michael E. DeBakey VA Medical Center: collaborator

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Pneumonia; Pneumococcal Infections; Pneumonia, Pneumococcal

Interventions

Heptavalent Pneumococcal Conjugate Vaccine; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pneumonia, Bacterial

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

Study Officials

• Daniel M Musher

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2006
• First Posted: March 17, 2006
• Study Start: January 1, 2003
• Primary Completion: September 1, 2006
• Study Completion: June 1, 2012
• Last Updated: September 5, 2017

Record last verified: 2017-09

Locations

US (1)