Study of Evaluation Indexes for Antibody Production in Sera After Immunization

Study Overview
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Brief Summary
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The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in children, adults and elderly.

Detailed Description
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To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from children, young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).

Official Title
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A Study of Evaluation Indexes for Antibody Production in Sera After Immunization

Conditions
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Aged

Intervention / Treatment
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* Biological: pneumococcal polysaccharide vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elderly subjects over the age 65 years who had not received pneumococcal vaccination adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination) children subjects over the age of 2 years with no previous history of pneumococcal vaccination Exclusion Criteria: immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 90 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

Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumococcal polysaccharide vaccine<br>The immunogenic response to the pneumococcal polysaccharide vaccine was compared between children, adults and elderly. | Biological: pneumococcal polysaccharide vaccine<br>* single intramuscular injection of 0.5 ml Pneumo23® (Sanofi-Aventis, Lyon France)<br>* Other names: Pneumo23®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly. |  | 1 month after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay) |  | 1 month after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal Vaccine, Aged