Clinical trial NCT02719379: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 20
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Change in asthma Control Status
timeFrame: approximately 1 year
Secondary outcomes:
measure: Comparison of PPSV23 vaccine serotype specific antibody response between asthmatic and non-asthmatic smokers
timeFrame: Vaccine response will be measured at 4 to 6 weeks after administration of vaccine
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rohit Divekar, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: