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Targeting of Immune Response After Pneumococcal Vaccination (PncHR)

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. Identifier: NCT01402245
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : July 26, 2011
Information provided by:
Helsinki University Central Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Pneumococcal Pneumonia Biological: Pneumococcal polysaccharide vaccine Biological: pneumococcal conjugate vaccine Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
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
Study Start Date : January 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

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

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).

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 identifier (NCT number): NCT01402245

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

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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 )
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: January 2007
Keywords provided by Helsinki University Central Hospital:
pneumococcal polysaccharide vaccine
pneumococcal conjugate vaccine
Additional relevant MeSH terms:
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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