Targeting of Immune Response After Pneumococcal Vaccination

NCT ID: NCT01402245

Last Updated: 2011-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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)

Conditions

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Pneumococcal Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pneumonia group

Patients with Pnc pneumonia

Group Type NO_INTERVENTION

No interventions assigned to this group

PPV Group

Volunteers immunized with Pnc polysaccharide vaccine

Group Type ACTIVE_COMPARATOR

Pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

Pneumococcal polysaccharide vaccine 0.5 ml i.m.

PCV Group

Volunteers immunized with Pnc conjugate vaccine

Group Type ACTIVE_COMPARATOR

pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

pneumococcal conjugate vaccine 0.5 ml i.m.

Interventions

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Pneumococcal polysaccharide vaccine

Pneumococcal polysaccharide vaccine 0.5 ml i.m.

Intervention Type BIOLOGICAL

pneumococcal conjugate vaccine

pneumococcal conjugate vaccine 0.5 ml i.m.

Intervention Type BIOLOGICAL

Other Intervention Names

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Pneumovax Prevenar

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Helsinki UYniversity Central Hospital

Principal Investigators

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Anu Kantele, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology

Helsinki, , Finland

Site Status

Division of Infectious Diseases, HUCH

Helsinki, , Finland

Site Status

Division of Microbiology, HUSLAB, Helsinki University Central Hospital

Helsinki, , Finland

Site Status

University of Turku

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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383/E5/07

Identifier Type: OTHER

Identifier Source: secondary_id

411/E5/02

Identifier Type: -

Identifier Source: org_study_id

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