Pneumococcal Vaccines in Patients With Asthma

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

Detailed Description
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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.

Official Title
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Immunogenicity of PPSV-23 After PCV-13 Vaccination in Adult Asthmatic Patients

Conditions
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Asthma

Intervention / Treatment
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* Biological: PCV13
* Biological: PPSV23


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCV13 and PPSV23<br>Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23 | Biological: PCV13<br>* Single 0.5 ml dose of PCV13 administered via intramuscular injection<br>* Other names: Prevnar;Biological: PPSV23<br>* Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously<br>* Other names: Pneumovax;|
| Active Comparator: PPSV23<br>Participants randomized to receive PPSV23 alone | Biological: PPSV23<br>* Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously<br>* Other names: Pneumovax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Baseline, week 0, week 8, week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Pneumococcal, Pneumonia