Immune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 asthma
Started Apr 2016
Typical duration for phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 25, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedOctober 11, 2017
October 1, 2017
1.2 years
March 14, 2016
October 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Comparison of PPSV23 vaccine serotype specific antibody response between asthmatic and non-asthmatic smokers
Vaccine response will be measured at 4 to 6 weeks after administration of vaccine
Study Arms (3)
Asthmatics
EXPERIMENTAL19-20 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 COMPARATOR19-20 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)
Asthmatics - Serum Stored
OTHEROnce 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rohit Divekarlead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rohit Divekar, MBBS, PhD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
March 14, 2016
First Posted
March 25, 2016
Study Start
April 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
October 11, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share