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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Biological: Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 20 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asthmatics; 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	Biological: Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23); Other Names: Pneumovax
Active Comparator: Non-asthmatics; 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)	Biological: Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23); Other Names: Pneumovax
Other: Asthmatics - Serum Stored; 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.	Biological: Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23); Other Names: Pneumovax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Rohit Divekar
• Investigators: Principal Investigator: Rohit Divekar, MBBS, PhD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: March 14, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): October 11, 2017
• Last Update Submitted That Met QC Criteria: October 9, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 15-005581

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No