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Pneumococcal Vaccines in Patients With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03260790
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Avni Joshi, Mayo Clinic

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: PCV13 and PPSV23
Participants randomized to receive PPSV23 primed with PCV13
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




Primary Outcome Measures :
  1. Change in Immune response at week 8 [ Time Frame: Baseline, week 8 ]
    5 ml blood draw for assessment of pneumococcal specific titers, IgG, IgM and IgA. These are all measured as mg/dL.

  2. Immune response [ Time Frame: week 8 ]
    5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. These are all measured as mcg/mL.

  3. Immune response [ Time Frame: week 16 ]
    5 ml blood draw for assessment of IgG specific Antibody titers to all 23 serotypes. These are all measured as mcg/mL.



Information from the National Library of Medicine

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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)

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


Contacts
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Contact: Kay A Bachman 507-284-5689 bachman.kay@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Avni Y Joshi Mayo Clinic
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
Last Update Posted: January 7, 2020
Last Verified: January 2020
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