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Targeting of Immune Response After Pneumococcal Vaccination (PncHR)

This study has been completed.
Information provided by:
Helsinki University Central Hospital Identifier:
First received: July 25, 2011
Last updated: NA
Last verified: January 2007
History: No changes posted
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)

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

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
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Please refer to this study by its identifier: NCT01402245

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
Principal Investigator: Anu Kantele, MD PhD Helsinki University Central Hospital
  More Information

Responsible Party: Anu Kantele, Helsinki UYniversity Central Hospital Identifier: NCT01402245     History of Changes
Other Study ID Numbers: 411/E5/02
383/E5/07 ( Other Identifier: Ethics Committee, Dept. of Medicine, HUCH )
Study First Received: July 25, 2011
Last Updated: July 25, 2011

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

Additional relevant MeSH terms:
Pneumonia, Pneumococcal
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017