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Pneumococcal Vaccines in Patients With Asthma

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Mayo Clinic

Status and phase

Completed
Phase 4

Conditions

Asthma

Treatments

Biological: PCV13
Biological: PPSV23

Study type

Interventional

Funder types

Other

Identifiers

NCT03260790
16-007731

Details and patient eligibility

About

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

Full 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.

Enrollment

17 patients

Sex

All

Ages

19 to 64 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

17 participants in 2 patient groups

PCV13 and PPSV23
Experimental group
Description:
Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23
Treatment:
Biological: PPSV23
Biological: PCV13
PPSV23
Active Comparator group
Description:
Participants randomized to receive PPSV23 alone
Treatment:
Biological: PPSV23

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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