Back to resultsImmune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)
Sponsored by
About this trial
This is an interventional basic science trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Reside in Olmsted County, Minnesota (defined by Olmsted County address in medical record within one year prior to last follow-up date as of data abstraction)
- Receive medical care from Mayo Clinic clinical practice
- Signed research authorization for using medical record for research
Exclusion Criteria:
- Diagnosis of an immunodeficiency (primary and secondary)
- Previous or current diagnosis of a Rheumatological disorders (Rheumatoid arthritis, Lupus, Sjögren, and vasculitis), cancer (chronic lymphocytic leukemia, non-Hodgkin lymphoma, and B-cell malignancy), diabetes, active infection (pneumonia, otitis media, HIV, and EBV), other chronic diseases (multiple sclerosis, etc), renal disease such nephritic syndrome, and protein losing enteropathy
- Current or previous use (within the last 6 months) of systemic corticosteroids, and other immunosuppressive agents (cyclosporin, methotrexate, and mycophenolic acid)
- Vaccination of PPSV-23 (receiving childhood pneumococcal vaccination during infancy is eligible for this study)
- Pregnancy
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Asthmatics
Non-asthmatics
Asthmatics - Serum Stored
Arm Description
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
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)
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02719379
Brief Title
Immune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma
Official Title
Immune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rohit Divekar
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asthmatics
Arm Type
Experimental
Arm Description
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
Arm Title
Non-asthmatics
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Asthmatics - Serum Stored
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)
Other Intervention Name(s)
Pneumovax
Primary Outcome Measure Information:
Title
Change in asthma Control Status
Description
Change in asthma control status will be assessed at end of 1 year follow up. Included would be Asthma Control Test (ACT) Score
Time Frame
approximately 1 year
Secondary Outcome Measure Information:
Title
Comparison of PPSV23 vaccine serotype specific antibody response between asthmatic and non-asthmatic smokers
Description
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)
Time Frame
Vaccine response will be measured at 4 to 6 weeks after administration of vaccine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Reside in Olmsted County, Minnesota (defined by Olmsted County address in medical record within one year prior to last follow-up date as of data abstraction)
Receive medical care from Mayo Clinic clinical practice
Signed research authorization for using medical record for research
Exclusion Criteria:
Diagnosis of an immunodeficiency (primary and secondary)
Previous or current diagnosis of a Rheumatological disorders (Rheumatoid arthritis, Lupus, Sjögren, and vasculitis), cancer (chronic lymphocytic leukemia, non-Hodgkin lymphoma, and B-cell malignancy), diabetes, active infection (pneumonia, otitis media, HIV, and EBV), other chronic diseases (multiple sclerosis, etc), renal disease such nephritic syndrome, and protein losing enteropathy
Current or previous use (within the last 6 months) of systemic corticosteroids, and other immunosuppressive agents (cyclosporin, methotrexate, and mycophenolic acid)
Vaccination of PPSV-23 (receiving childhood pneumococcal vaccination during infancy is eligible for this study)
Pregnancy
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohit Divekar, MBBS, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma
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