Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Targeting of Immune Response After Pneumococcal Vaccination (PncHR)

This study has been completed.
Sponsor:
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01402245
First received: July 25, 2011
Last updated: NA
Last verified: January 2007
History: No changes posted
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402245

Locations
Finland
Division of Infectious Diseases, HUCH
Helsinki, Finland, 00029
Division of Microbiology, HUSLAB, Helsinki University Central Hospital
Helsinki, Finland, 00029
University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology
Helsinki, Finland, 00014
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

No publications provided

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
Study First Received: July 25, 2011
Last Updated: July 25, 2011
Health Authority: Finland: Finnish Medicines Agency

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

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumococcal
Bacterial Infections
Gram-Positive Bacterial Infections
Lung Diseases
Pneumococcal Infections
Pneumonia, Bacterial
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections

ClinicalTrials.gov processed this record on November 24, 2014