Phase 4
N=17
Pneumococcal Vaccines in Patients With Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03260790 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 — 109.8; 53.9; 142.3; 53.9 mcg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- PCV13 (Biological); PPSV23 (Biological)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 |
109.8; 53.9; 142.3; 53.9; 211.7; 243.3 | — |
| PRIMARY Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 |
228.0; 206.8; 506.3; 206.8; 502.9; 449.4 | — |
| PRIMARY Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 |
142.4; 107.4; 418.9; 107.4; 362.8; 229.4 | — |
| PRIMARY Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. |
89.2; 74.7; 82.4; 74.7; 174.2; 220.0 | — |
Summary
Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine if they are given Prevnar initially.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03260790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.