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Advisory Committee for Immunization Practices (ACIP) from the Centers for Disease Control (CDC) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung condition such as asthma or cigarette smoking be vaccinated with Pneumococcal vaccine (PPSV23). The purpose of this study is to increase awareness of vaccination to late adolescents with asthma and smokers (social aspect of study), and to recommend vaccination (which is the clinical aspect). Individuals who agree to receiving vaccine will be enrolled in research to determine whether late adolescents with and without asthma (smokers) have distinctive pneumococcal vaccine response patterns and whether such patterns are associated with subsequent variance in asthma outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthmatics | Experimental | 19-20 year old asthmatics who agree to participate in study will have serum collected for analysis. PPSV23 vaccine [Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)] will be offered per the ACIP/CDC guidelines. Those who agree to receive the vaccine will have a second draw for serum 4-6 weeks post vaccination for immunization response. They will also be follow up after 1 year to assess for asthma control and outcomes. This arm will additionally allow for comparison of asthma outcomes and vaccine response |
|
| Non-asthmatics | Active Comparator | 19-20 year old non-asthmatic smokers who agree to participate in study will have serum collected for analysis. PPSV23 vaccine [Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)] will be offered per the ACIP/CDC guidelines. Those who agree to receive the vaccine will have a second draw for serum 4-6 weeks post vaccination for immunization response. This arm will allow for comparison of vaccine response between asthmatics and non-asthmatics (smokers) |
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| Asthmatics - Serum Stored | Other | Once the accrual for the experimental arm is met, 19-20 year old asthmatics who wish to participate in study will have serum collected for analysis. PPSV23 vaccine [Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)] will be offered per the ACIP/CDC guidelines. This arm will allow for study of baseline vaccine titers to pneumococcus in asthmatics at same time increase the vaccine uptake in the community. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in asthma Control Status | Change in asthma control status will be assessed at end of 1 year follow up. Included would be Asthma Control Test (ACT) Score | approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of PPSV23 vaccine serotype specific antibody response between asthmatic and non-asthmatic smokers | Vaccine response in form of serotype titers to pneumococcal antigens will be measured 4-6 weeks after vaccination and post vaccine titers will be compared with pre-vaccine titers between asthmatics and non-asthmatics (smokers) | Vaccine response will be measured at 4 to 6 weeks after administration of vaccine |
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Inclusion Criteria:
Exclusion Criteria:
Enrollment will be delayed 2 weeks for those subjects that can be included but have upper respiratory infection or viral illness to allow for natural resolution.
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| Name | Affiliation | Role |
|---|---|---|
| Rohit Divekar, MBBS, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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