Pneumococcal Post-Vaccination Titers

NCT ID: NCT02726347

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-04-30

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.

Detailed Description

One hundred forty subjects will have pre-vaccination titers checked for the 23 serotypes in the PPV-23 vaccine. They will then receive the vaccine. All subjects will be given the vaccination as standard of care. Approximately 4 weeks following immunization, the subjects will have post-vaccination titers checked to the same serotypes checked prior to vaccination.

Conditions

Smokers, Elderly, Asthma, COPD, Recurrent Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Smokers between the ages of 19-80

current smokers between the ages of 19 and 80

Group Type: ACTIVE_COMPARATOR

PPV-23

Intervention Type: BIOLOGICAL

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.

elderly individuals (over age 50)

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

Group Type: ACTIVE_COMPARATOR

PPV-23

Intervention Type: BIOLOGICAL

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.

COPD subjects

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

Group Type: ACTIVE_COMPARATOR

PPV-23

Intervention Type: BIOLOGICAL

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.

Asthmatics subjects

Asthmatics between the ages of 19 and 80

Group Type: ACTIVE_COMPARATOR

PPV-23

Intervention Type: BIOLOGICAL

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.

Subjects with 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

Group Type: ACTIVE_COMPARATOR

PPV-23

Intervention Type: BIOLOGICAL

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.

Interventions

PPV-23

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

polysaccharide pneumococcal vaccine

Eligibility Criteria

Inclusion Criteria

Informed consent will be administered to individuals from 5 cohorts each with 28 subjects for a total of 140 subjects. The cohorts will be:

1. smokers between the ages of 19-80.

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

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

4. Asthmatics between the ages of 19 and 80, without a history of recurrent bacterial infections.

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

Exclusion Criteria

The following groups will be excluded:

1. Subjects who are currently receiving or have ever received immunoglobulin replacement therapy.

2. subjects who are on immune suppressive agents.

3. 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.

4. subjects on antiepileptic agents.

5. Subjects who have received the pneumococcal polysaccharide vaccine, PPV-23 6) Pregnant women

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Jewish Health

OTHER

Sponsor Role: lead

Responsible Party

Flavia Hoyte

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Jewish Health

Denver, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Flavia Hoyte, MD

Role: CONTACT

hoytef@njhealth.org

Facility Contacts

NJH CTRC Program Administrator

Role: primary

303-398-1409

Other Identifiers

HS-2953

Identifier Type: -

Identifier Source: org_study_id