Targeting of Immune Response After Pneumococcal Vaccination
PncHR
Comparison of Immune Response in Pneumococcal Pneumonia and After Vaccination
2 other identifiers
interventional
42
1 country
4
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2005
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 25, 2011
CompletedFirst Posted
Study publicly available on registry
July 26, 2011
CompletedJuly 26, 2011
January 1, 2007
5.4 years
July 25, 2011
July 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Expression of homing receptors on circulating plasmablasts in Pnc pneumonia and after vaccination
HR on circulating Pnc-specific plasmablasts are determined in patients with pneumonia on day 7-10, in vaccinees on days 0 and 7
Day 0 and Day 7-10
Study Arms (3)
Pneumonia group
NO INTERVENTIONPatients with Pnc pneumonia
PPV Group
ACTIVE COMPARATORVolunteers immunized with Pnc polysaccharide vaccine
PCV Group
ACTIVE COMPARATORVolunteers immunized with Pnc conjugate vaccine
Interventions
Pneumococcal polysaccharide vaccine 0.5 ml i.m.
pneumococcal conjugate vaccine 0.5 ml i.m.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \< 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology
Helsinki, 00014, Finland
Division of Infectious Diseases, HUCH
Helsinki, 00029, Finland
Division of Microbiology, HUSLAB, Helsinki University Central Hospital
Helsinki, 00029, Finland
University of Turku
Turku, 20520, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anu Kantele, MD PhD
Helsinki University Central Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 25, 2011
First Posted
July 26, 2011
Study Start
January 1, 2005
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
July 26, 2011
Record last verified: 2007-01