Targeting of Immune Response After Pneumococcal Vaccination

Phase 4

Completed

• Conditions: Pneumococcal Pneumonia
• Interventions: Biological: Pneumococcal polysaccharide vaccine; Biological: pneumococcal conjugate vaccine

• Registration Number: NCT01402245
• Lead Sponsor: Helsinki University Central Hospital

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)

Study Timeline

• Study Start: 2005-01
• Status Verified: 2007-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Last Update Submitted: 2011-07-25
• Study First Posted: 2011-07-26
• Last Update Posted: 2011-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPV Group	Pneumococcal polysaccharide vaccine	Volunteers immunized with Pnc polysaccharide vaccine
PCV Group	pneumococcal conjugate vaccine	Volunteers immunized with Pnc conjugate vaccine

Primary Outcome Measures

Name	Time	Method
Expression of homing receptors on circulating plasmablasts in Pnc pneumonia and after vaccination	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

Trial Locations

Locations (4)

University of Turku; 🇫🇮 Turku, Finland

Division of Infectious Diseases, HUCH; 🇫🇮 Helsinki, Finland

University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology; 🇫🇮 Helsinki, Finland

Division of Microbiology, HUSLAB, Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland