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

NCT ID: NCT02719379

Last Updated: 2017-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)

Intervention Type BIOLOGICAL

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)

Group Type ACTIVE_COMPARATOR

Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)

Intervention Type BIOLOGICAL

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.

Group Type OTHER

Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)

Intervention Type BIOLOGICAL

Interventions

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Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)

Intervention Type BIOLOGICAL

Other Intervention Names

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Pneumovax

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rohit Divekar

OTHER

Sponsor Role lead

Responsible Party

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Rohit Divekar

Assistant Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rohit Divekar, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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15-005581

Identifier Type: -

Identifier Source: org_study_id