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Targeting of Immune Response After Pneumococcal Vaccination (PncHR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402245
First Posted: July 26, 2011
Last Update Posted: July 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Helsinki University Central Hospital
  Purpose
Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study aims to compare lymphocyte homing in pneumonia and in those receiving Pnc polysaccharide vaccine (PPV) or Pnc conjugate vaccine (PCV)

Condition Intervention Phase
Pneumococcal Pneumonia Biological: Pneumococcal polysaccharide vaccine Biological: pneumococcal conjugate vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Immune Response in Pneumococcal Pneumonia and After Vaccination

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Expression of homing receptors on circulating plasmablasts in Pnc pneumonia and after vaccination [ Time Frame: Day 0 and Day 7-10 ]
    HR on circulating Pnc-specific plasmablasts are determined in patients with pneumonia on day 7-10, in vaccinees on days 0 and 7


Enrollment: 42
Study Start Date: January 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Pneumonia group
Patients with Pnc pneumonia
Active Comparator: PPV Group
Volunteers immunized with Pnc polysaccharide vaccine
Biological: Pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccine 0.5 ml i.m.
Other Name: Pneumovax
Active Comparator: PCV Group
Volunteers immunized with Pnc conjugate vaccine
Biological: pneumococcal conjugate vaccine
pneumococcal conjugate vaccine 0.5 ml i.m.
Other Name: Prevenar

Detailed Description:
Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study compares the homing profiles of Pnc-specific plasmablasts in 15 patients with pneumonia and in 15 volunteers receiving Pnc polysaccharide vaccine (PPV) and 12 volunteers receiving Pnc conjugate vaccine (PCV)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females ≥ 18 and <65 years of age.
  • General good health.
  • Written informed consent.
  • No previous vaccination against Pnc
  • No previous history of Pnc pneumonia
  • In pneumonia: Diagnosis of Pnc pneumonia within a week

Exclusion Criteria:

  • < 18 years, ≥65 of age.
  • In vaccinees: Acute disease at the time of enrollment.
  • Pregnancy or lactation.
  • Known immunodeficiency or immune suppressive treatment.
  • Any chronic illness that might interfere with the immune response
  • Alcohol or drug abuse
  • Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402245


Locations
Finland
University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology
Helsinki, Finland, 00014
Division of Infectious Diseases, HUCH
Helsinki, Finland, 00029
Division of Microbiology, HUSLAB, Helsinki University Central Hospital
Helsinki, Finland, 00029
University of Turku
Turku, Finland, 20520
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Anu Kantele, MD PhD Helsinki University Central Hospital
  More Information

Responsible Party: Anu Kantele, Helsinki UYniversity Central Hospital
ClinicalTrials.gov Identifier: NCT01402245     History of Changes
Other Study ID Numbers: 411/E5/02
383/E5/07 ( Other Identifier: Ethics Committee, Dept. of Medicine, HUCH )
First Submitted: July 25, 2011
First Posted: July 26, 2011
Last Update Posted: July 26, 2011
Last Verified: January 2007

Keywords provided by Helsinki University Central Hospital:
pneumonia
pneumococcal polysaccharide vaccine
pneumococcal conjugate vaccine

Additional relevant MeSH terms:
Pneumonia, Pneumococcal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs