Pneumococcal Vaccines in Patients With Asthma

October 7, 2021 updated by: Avni Joshi, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Prevnar
Biological: PPSV23
Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
Other Names:
  • 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 Names:
  • Pneumovax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 0, week 8, week 16
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.
Baseline, week 0, week 8, week 16
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.
Baseline, week 0, week 8, week 16
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.
Baseline, week 0, week 8, week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Avni Y Joshi, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

December 21, 2020

Study Completion (ACTUAL)

December 25, 2020

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (ACTUAL)

August 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-007731

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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