Pneumococcal Vaccines in Patients With Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03260790
• Other study ID #: 16-007731
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: December 25, 2020

Study information

• Verified date: October 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 25, 2020
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• PCV13
Single 0.5 ml dose of PCV13 administered via intramuscular injection
• PPSV23
Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Mayo Clinic Clinical Trials