Pneumococcal Vaccines in Patients With Asthma

Phase 4

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
PCV13 and PPSV23	PCV13	Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23
PCV13 and PPSV23	PPSV23	Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23
PPSV23	PPSV23	Participants randomized to receive PPSV23 alone

Primary Outcome Measures

Name	Time	Method
Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.	Baseline, week 0, week 8, week 16	5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.
Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16	Baseline, week 0, week 8, week 16	5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.
Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16	Baseline, week 0, week 8, week 16	5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.
Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16	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.