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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719379
• Other study ID #: 15-005581
• Status: Completed
• Phase: Phase 1
• First received: March 14, 2016
• Last updated: October 9, 2017
• Start date: April 2016
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Rohit Divekar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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