Targeting of Immune Response After Pneumococcal Vaccination

Study Overview
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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)

Official Title
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Comparison of Immune Response in Pneumococcal Pneumonia and After Vaccination

Conditions
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Pneumococcal Pneumonia

Intervention / Treatment
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* Biological: Pneumococcal polysaccharide vaccine
* Biological: pneumococcal conjugate vaccine


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pneumonia group<br>Patients with Pnc pneumonia | |
| Active Comparator: PPV Group<br>Volunteers immunized with Pnc polysaccharide vaccine | Biological: Pneumococcal polysaccharide vaccine<br>* Pneumococcal polysaccharide vaccine 0.5 ml i.m.<br>* Other names: Pneumovax;|
| Active Comparator: PCV Group<br>Volunteers immunized with Pnc conjugate vaccine | Biological: pneumococcal conjugate vaccine<br>* pneumococcal conjugate vaccine 0.5 ml i.m.<br>* Other names: Prevenar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pneumonia, pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine