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Pneumococcal Vaccines in Patients With Asthma

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ClinicalTrials.gov Identifier: NCT03260790
Recruitment Status : Completed
First Posted : August 24, 2017
Results First Posted : November 5, 2021
Last Update Posted : November 5, 2021
Sponsor:
Information provided by (Responsible Party):
Avni Joshi, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Asthma Biological: PCV13 Biological: PPSV23 Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity of PPSV-23 After PCV-13 Vaccination in Adult Asthmatic Patients
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : December 21, 2020
Actual Study Completion Date : December 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: PCV13 and PPSV23
Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23
 Biological: PCV13
Single 0.5 ml dose of PCV13 administered via intramuscular injection
Other Name: Prevnar

Biological: PPSV23
Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
Other Name: Pneumovax
Active Comparator: PPSV23
Participants randomized to receive PPSV23 alone
 Biological: PPSV23
Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
Other Name: Pneumovax


Outcome Measures
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Primary Outcome Measures :
  1. Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16 [ Time Frame: Baseline, week 0, week 8, week 16 ]
    5 ml blood draw for assessment of pneumococcal specific titer IgG. Measured as mcg/dL.

  2. Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16 [ Time Frame: 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.

  3. Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16 [ Time Frame: 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.

  4. Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260790


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Avni Y Joshi Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Avni Joshi, Mayo Clinic:
Study Protocol and Statistical Analysis Plan  [PDF] June 7, 2018

More Information
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Additional Information:

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Responsible Party: Avni Joshi, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03260790    
Other Study ID Numbers: 16-007731
First Posted: August 24, 2017    Key Record Dates
Results First Posted: November 5, 2021
Last Update Posted: November 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Avni Joshi, Mayo Clinic:
Vaccine
Pneumococcal
Pneumonia
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs