NCT03260790

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
11 months until next milestone

Results Posted

Study results publicly available

November 5, 2021

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

3.2 years

First QC Date

July 31, 2017

Results QC Date

October 7, 2021

Last Update Submit

October 7, 2021

Conditions

Asthma

Keywords

VaccinePneumococcalPneumonia

Outcome Measures

Primary Outcomes (4)

  • Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and 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

    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

    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.

    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

Study Arms (2)

PCV13 and PPSV23

EXPERIMENTAL

Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23

Biological: PCV13Biological: PPSV23

PPSV23

ACTIVE COMPARATOR

Participants randomized to receive PPSV23 alone

Biological: PPSV23

Interventions

PCV13BIOLOGICAL

Single 0.5 ml dose of PCV13 administered via intramuscular injection

Also known as: Prevnar
PCV13 and PPSV23
PPSV23BIOLOGICAL

Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously

Also known as: Pneumovax
PCV13 and PPSV23PPSV23

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- Diagnosis of asthma

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

AsthmaPneumonia

Interventions

Heptavalent Pneumococcal Conjugate Vaccine23-valent pneumococcal capsular polysaccharide vaccinePneumococcal Vaccines

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfections

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex MixturesVaccines, Combined

Results Point of Contact

Title
Avni Y. Joshi, M.D., M.S.
Organization
Mayo Clinic
Joshi.Avni@mayo.edu
507-284-3165

Study Officials

  • Avni Y Joshi

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 24, 2017

Study Start

October 1, 2017

Primary Completion

December 21, 2020

Study Completion

December 25, 2020

Last Updated

November 5, 2021

Results First Posted

November 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)