Targeting of Immune Response After Pneumococcal Vaccination

Pneumococcal Pneumonia Clinical Trial

— PncHR  

Official title:

Comparison of Immune Response in Pneumococcal Pneumonia and After Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402245
• Other study ID #: 411/E5/02
• Secondary ID: 383/E5/07
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2011
• Last updated: July 25, 2011
• Start date: January 2005
• Est. completion date: June 2010

Study information

• Verified date: January 2007
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Pneumonia
• Pneumonia
• Pneumonia, Pneumococcal

Intervention

Biological:
• Pneumococcal polysaccharide vaccine
Pneumococcal polysaccharide vaccine 0.5 ml i.m.
• pneumococcal conjugate vaccine
pneumococcal conjugate vaccine 0.5 ml i.m.

Locations

Country	Name	City	State
Finland	Division of Infectious Diseases, HUCH	Helsinki
Finland	Division of Microbiology, HUSLAB, Helsinki University Central Hospital	Helsinki
Finland	University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology	Helsinki
Finland	University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No