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OpenTrials
Completed

NCT Number: NCT03260790

Pneumococcal Vaccines in Patients With Asthma

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Obstructive Pneumonia Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PCV13

Biological

Single 0.5 ml dose of PCV13 administered via intramuscular injection

Other names: Prevnar

PPSV23

Biological

Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously

Other names: Pneumovax

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 24, 2017
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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