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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smokers between the ages of 19-80 | Active Comparator | current smokers between the ages of 19 and 80 |
|
| elderly individuals (over age 50) | Active Comparator | elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD, or asthma |
|
| COPD subjects | Active Comparator | COPD subjects between the age of 19 and 80, without history of recurrent bacterial infections. |
|
| Asthmatics subjects | Active Comparator | Asthmatics between the ages of 19 and 80 |
|
| Subjects with recurrent bacterial infections | Active Comparator | Individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPV-23 | Biological | 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. |
| 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 |
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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:
Exclusion Criteria:
The following groups will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Flavia Hoyte, MD | Contact | hoytef@njhealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Recruiting | Denver | Colorado | 80206 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000084063 | Reinfection |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012008 | Recurrence |
| D045424 |
| Complex Mixtures |