Pneumococcal Post-Vaccination Titers

National Jewish Health

Status: Unknown

Conditions: Smokers, Elderly, Asthma, COPD, Recurrent Infections

Treatments: Biological: PPV-23

Study type: Interventional

Funder types: Other

Identifiers

NCT02726347

HS-2953

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 5 patient groups

Smokers between the ages of 19-80

Active Comparator group

Description:

current smokers between the ages of 19 and 80

Treatment:

Biological: PPV-23

elderly individuals (over age 50)

Active Comparator group

Description:

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

Treatment:

Biological: PPV-23

COPD subjects

Active Comparator group

Description:

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

Treatment:

Biological: PPV-23

Asthmatics subjects

Active Comparator group

Description:

Asthmatics between the ages of 19 and 80

Treatment:

Biological: PPV-23

Subjects with recurrent bacterial infections

Active Comparator group

Description:

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

Treatment:

Biological: PPV-23