Pneumococcal Vaccines in Patients With Asthma
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 19 - 64 |
| Updated: | 3/7/2019 |
| Start Date: | October 1, 2017 |
| End Date: | December 2019 |
| Contact: | Kay A Bachman |
| Email: | bachman.kay@mayo.edu |
| Phone: | 507-284-5689 |
Immunogenicity of PPSV-23 After PCV-13 Vaccination in Adult Asthmatic Patients
Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine
if they are given Prevnar initially.
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.
(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.
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)
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