NCT02726347

Brief Summary

The study is looking at the pneumonia vaccine and the immune system response to this vaccine. The information gathered from this study may be important for your doctor to take care of patients with smoking histories, immune deficiency, asthma, Chronic Obstructive Pulmonary Disease (COPD), or elderly patients. It is important that your immune system builds a strong defense to the vaccine so that you are better able to fight a bacterium that can cause pneumonia. Some disease prevent the immune system from building a strong defense and these patients will not benefit from the vaccine.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

March 29, 2016

Last Update Submit

September 12, 2017

Conditions

Smokers, Elderly, Asthma, COPD, Recurrent Infections

Outcome Measures

Primary Outcomes (1)

  • Change from pre-to post-vaccination antibody titer

    Evaluate the immune response in the 5 groups of subjects

    day one- day of vaccine and one month later

Study Arms (5)

Smokers between the ages of 19-80

ACTIVE COMPARATOR

current smokers between the ages of 19 and 80

Biological: PPV-23

elderly individuals (over age 50)

ACTIVE COMPARATOR

elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD, or asthma

Biological: PPV-23

COPD subjects

ACTIVE COMPARATOR

COPD subjects between the age of 19 and 80, without history of recurrent bacterial infections.

Biological: PPV-23

Asthmatics subjects

ACTIVE COMPARATOR

Asthmatics between the ages of 19 and 80

Biological: PPV-23

Subjects with recurrent bacterial infections

ACTIVE COMPARATOR

Individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency

Biological: PPV-23

Interventions

PPV-23BIOLOGICAL

one hundred forty subjects will have pre-vaccination titers checked. All will be given vaccination as standard of care. Approximately 4 weeks later subjects will have post-vaccination titers checked for the same serotypes.

Also known as: polysaccharide pneumococcal vaccine
Asthmatics subjectsCOPD subjectsSmokers between the ages of 19-80Subjects with recurrent bacterial infectionselderly individuals (over age 50)

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent will be administered to individuals from 5 cohorts each with 28 subjects for a total of 140 subjects. The cohorts will be:
  • smokers between the ages of 19-80.
  • elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD or asthma.
  • COPD subjects between the age of 19 and 80, without a history of recurrent bacterial infections.
  • Asthmatics between the ages of 19 and 80, without a history of recurrent bacterial infections.
  • individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency.

You may not qualify if:

  • The following groups will be excluded:
  • Subjects who are currently receiving or have ever received immunoglobulin replacement therapy.
  • subjects who are on immune suppressive agents.
  • Subjects who are on chronic steroids or have received an intramuscular injection of steroids in the three months prior to enrollment or oral/intravenous steroids within a month of enrollment or two or more prednisone bursts in the past year.
  • subjects on antiepileptic agents.
  • Subjects who have received the pneumococcal polysaccharide vaccine, PPV-23 6) Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic ObstructiveReinfection

Interventions

Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRecurrence

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Central Study Contacts

Flavia Hoyte, MD

CONTACT

hoytef@njhealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 1, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

US(1)