Pneumococcal Vaccines in Patients With Asthma

Mayo Clinic17 enrolled

Overview

Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine if they are given Prevnar initially.

Patients will be randomized into either PCV13 and PPSV23 (Experimental) or PPSV23 alone (Active comparator). At the Week 0 time point, the patients will receive either PCV13 (Experimental) or PPSV23 (Active comparator) and undergo a blood draw of 5ml for assessment of pre-vacation serotype titers. The Active Comparator group will undergo a 5ml draw of blood for assessment of titers at week 8, 16, and 24 following vaccination. The Experimental group will undergo vaccination with PPSV23 at week 8 with 5 ml blood draw for pneumococcal serotype titers as well as a blood draw at week 16 and week 24.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

PCV13BIOLOGICAL

Single 0.5 ml dose of PCV13 administered via intramuscular injection

PPSV23BIOLOGICAL

Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously

Eligibility

Sex: ALLMin age: 19 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Diagnosis of asthma Exclusion Criteria: * Research exemption requested * History of PCV-13 vaccination * History of cochlear implant * Cerebrospinal Fluid (CSF) leak * Congestive Heart Failure (CHF) * Diabetes Mellitus (DM) * Chronic Kidney Disease (CKD) * Human Immunodeficiency Virus (HIV) * Common Variable Immune Deficiency (CVID) * Patients who have received the PPSV23 vaccine in the last 5 years * Women who are pregnant will also be excluded from the study by performing 2 point of care urine pregnancy tests ( prior to vaccinations)

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16

5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.

Time frame: Baseline, week 0, week 8, week 16

Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16

5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.

Time frame: Baseline, week 0, week 8, week 16

Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16

5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 \& PPSV23. Measured as mcg/mL.

Time frame: Baseline, week 0, week 8, week 16

Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.

5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.

Time frame: Baseline, week 0, week 8, week 16

Data from ClinicalTrials.gov

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