Immune Response to Pneumococcal Polysaccharide Vaccine (23-valent) Predicts Asthma Status and Outcomes in Late Adolescents With Asthma

Phase 1

Completed

• Conditions: Asthma

• Registration Number: NCT02719379
• Lead Sponsor: Rohit Divekar

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Study Start: 2016-04
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-09
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in asthma Control Status	approximately 1 year	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

Name	Time	Method
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	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)

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States