Targeting of Immune Response After Pneumococcal Vaccination (PncHR)

July 25, 2011 updated by: Helsinki University Central Hospital

Comparison of Immune Response in Pneumococcal Pneumonia and After Vaccination

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00014
        • University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology
      • Helsinki, Finland, 00029
        • Division of Infectious Diseases, HUCH
      • Helsinki, Finland, 00029
        • Division of Microbiology, HUSLAB, Helsinki University Central Hospital
      • Turku, Finland, 20520
        • University of Turku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Pneumovax
ACTIVE_COMPARATOR: PCV Group
Volunteers immunized with Pnc conjugate vaccine
Biological: pneumococcal conjugate vaccine
pneumococcal conjugate vaccine 0.5 ml i.m.
Other Names:
  • Prevenar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 0 and Day 7-10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (ESTIMATE)

July 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 25, 2011

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 411/E5/02
  • 383/E5/07 (OTHER: Ethics Committee, Dept. of Medicine, HUCH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumococcal Pneumonia

Clinical Trials on Pneumococcal polysaccharide vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe