Pneumococcal Post-Vaccination Titers

Study Overview
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Brief Summary
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The study is looking at the pneumonia vaccine and the immune system response to this vaccine. The information gathered from this study may be important for your doctor to take care of patients with smoking histories, immune deficiency, asthma, Chronic Obstructive Pulmonary Disease (COPD), or elderly patients. It is important that your immune system builds a strong defense to the vaccine so that you are better able to fight a bacterium that can cause pneumonia. Some disease prevent the immune system from building a strong defense and these patients will not benefit from the vaccine.

Detailed Description
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One hundred forty subjects will have pre-vaccination titers checked for the 23 serotypes in the PPV-23 vaccine. They will then receive the vaccine. All subjects will be given the vaccination as standard of care. Approximately 4 weeks following immunization, the subjects will have post-vaccination titers checked to the same serotypes checked prior to vaccination.

Official Title
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Pneumococcal Post-Vaccination Titers

Conditions
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Smokers, Elderly, Asthma, COPD, Recurrent Infections

Intervention / Treatment
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* Biological: PPV-23


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent will be administered to individuals from 5 cohorts each with 28 subjects for a total of 140 subjects. The cohorts will be: smokers between the ages of 19-80. elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD or asthma. COPD subjects between the age of 19 and 80, without a history of recurrent bacterial infections. Asthmatics between the ages of 19 and 80, without a history of recurrent bacterial infections. individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency. Exclusion Criteria: The following groups will be excluded: Subjects who are currently receiving or have ever received immunoglobulin replacement therapy. subjects who are on immune suppressive agents. Subjects who are on chronic steroids or have received an intramuscular injection of steroids in the three months prior to enrollment or oral/intravenous steroids within a month of enrollment or two or more prednisone bursts in the past year. subjects on antiepileptic agents. Subjects who have received the pneumococcal polysaccharide vaccine, PPV-23 6) Pregnant women

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 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: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Smokers between the ages of 19-80<br>current smokers between the ages of 19 and 80 | Biological: PPV-23<br>* one hundred forty subjects will have pre-vaccination titers checked. All will be given vaccination as standard of care. Approximately 4 weeks later subjects will have post-vaccination titers checked for the same serotypes.<br>* Other names: polysaccharide pneumococcal vaccine;|
| Active Comparator: elderly individuals (over age 50)<br>elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD, or asthma | Biological: PPV-23<br>* one hundred forty subjects will have pre-vaccination titers checked. All will be given vaccination as standard of care. Approximately 4 weeks later subjects will have post-vaccination titers checked for the same serotypes.<br>* Other names: polysaccharide pneumococcal vaccine;|
| Active Comparator: COPD subjects<br>COPD subjects between the age of 19 and 80, without history of recurrent bacterial infections. | Biological: PPV-23<br>* one hundred forty subjects will have pre-vaccination titers checked. All will be given vaccination as standard of care. Approximately 4 weeks later subjects will have post-vaccination titers checked for the same serotypes.<br>* Other names: polysaccharide pneumococcal vaccine;|
| Active Comparator: Asthmatics subjects<br>Asthmatics between the ages of 19 and 80 | Biological: PPV-23<br>* one hundred forty subjects will have pre-vaccination titers checked. All will be given vaccination as standard of care. Approximately 4 weeks later subjects will have post-vaccination titers checked for the same serotypes.<br>* Other names: polysaccharide pneumococcal vaccine;|
| Active Comparator: Subjects with recurrent bacterial infections<br>Individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency | Biological: PPV-23<br>* one hundred forty subjects will have pre-vaccination titers checked. All will be given vaccination as standard of care. Approximately 4 weeks later subjects will have post-vaccination titers checked for the same serotypes.<br>* Other names: polysaccharide pneumococcal vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from pre-to post-vaccination antibody titer | Evaluate the immune response in the 5 groups of subjects | day one- day of vaccine and one month later |