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Targeting of Immune Response After Pneumococcal Vaccination (PncHR)

Primary Purpose

Pneumococcal Pneumonia

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Pneumococcal polysaccharide vaccine
pneumococcal conjugate vaccine
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Pneumonia focused on measuring pneumonia, pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology
  • Division of Infectious Diseases, HUCH
  • Division of Microbiology, HUSLAB, Helsinki University Central Hospital
  • University of Turku

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Pneumonia group

PPV Group

PCV Group

Arm Description

Patients with Pnc pneumonia

Volunteers immunized with Pnc polysaccharide vaccine

Volunteers immunized with Pnc conjugate vaccine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 25, 2011
Last Updated
July 25, 2011
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01402245
Brief Title
Targeting of Immune Response After Pneumococcal Vaccination
Acronym
PncHR
Official Title
Comparison of Immune Response in Pneumococcal Pneumonia and After Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Pneumonia
Keywords
pneumonia, pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pneumonia group
Arm Type
No Intervention
Arm Description
Patients with Pnc pneumonia
Arm Title
PPV Group
Arm Type
Active Comparator
Arm Description
Volunteers immunized with Pnc polysaccharide vaccine
Arm Title
PCV Group
Arm Type
Active Comparator
Arm Description
Volunteers immunized with Pnc conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Pneumococcal polysaccharide vaccine
Other Intervention Name(s)
Pneumovax
Intervention Description
Pneumococcal polysaccharide vaccine 0.5 ml i.m.
Intervention Type
Biological
Intervention Name(s)
pneumococcal conjugate vaccine
Other Intervention Name(s)
Prevenar
Intervention Description
pneumococcal conjugate vaccine 0.5 ml i.m.
Primary Outcome Measure Information:
Title
Expression of homing receptors on circulating plasmablasts in Pnc pneumonia and after vaccination
Description
HR on circulating Pnc-specific plasmablasts are determined in patients with pneumonia on day 7-10, in vaccinees on days 0 and 7
Time Frame
Day 0 and Day 7-10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anu Kantele, MD PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology
City
Helsinki
ZIP/Postal Code
00014
Country
Finland
Facility Name
Division of Infectious Diseases, HUCH
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Division of Microbiology, HUSLAB, Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
University of Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland

12. IPD Sharing Statement

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Targeting of Immune Response After Pneumococcal Vaccination

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