Back to resultsPneumococcal Vaccines in Patients With Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PCV13
PPSV23
Sponsored by
About this trial
This is an interventional prevention trial for Asthma focused on measuring Vaccine, Pneumococcal, Pneumonia
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)
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PCV13 and PPSV23
PPSV23
Arm Description
Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23
Participants randomized to receive PPSV23 alone
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03260790
Brief Title
Pneumococcal Vaccines in Patients With Asthma
Official Title
Immunogenicity of PPSV-23 After PCV-13 Vaccination in Adult Asthmatic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 21, 2020 (Actual)
Study Completion Date
December 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Vaccine, Pneumococcal, Pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCV13 and PPSV23
Arm Type
Experimental
Arm Description
Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23
Arm Title
PPSV23
Arm Type
Active Comparator
Arm Description
Participants randomized to receive PPSV23 alone
Intervention Type
Biological
Intervention Name(s)
PCV13
Other Intervention Name(s)
Prevnar
Intervention Description
Single 0.5 ml dose of PCV13 administered via intramuscular injection
Intervention Type
Biological
Intervention Name(s)
PPSV23
Other Intervention Name(s)
Pneumovax
Intervention Description
Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
Primary Outcome Measure Information:
Title
Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
Description
5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.
Time Frame
Baseline, week 0, week 8, week 16
Title
Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
Description
5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. Measured as mcg/mL.
Time Frame
Baseline, week 0, week 8, week 16
Title
Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
Description
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes common PCV13 & PPSV23. Measured as mcg/mL.
Time Frame
Baseline, week 0, week 8, week 16
Title
Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
Description
5 ml blood draw for assessment of IgG specific Antibody titers for serotypes unique to PPSV23. Measured as mcg/mL.
Time Frame
Baseline, week 0, week 8, week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avni Y Joshi
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Pneumococcal Vaccines in Patients With Asthma
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