Pneumococcal Post-Vaccination Titers

National Jewish Health140 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

140

Conditions

Smokers, Elderly, Asthma, COPD, Recurrent Infections

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.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

National Jewish Health

Denver, Colorado, United States

RECRUITING

Outcomes

Primary Outcomes

Change from pre-to post-vaccination antibody titer

Evaluate the immune response in the 5 groups of subjects

Time frame: day one- day of vaccine and one month later

Central Contacts

Flavia Hoyte, MD

CONTACT

hoytef@njhealth.org

Data from ClinicalTrials.gov

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