Pneumococcal Post-Vaccination Titers

Not Applicable

• Conditions: Smokers, Elderly, Asthma, COPD, Recurrent Infections
• Interventions: Biological: PPV-23

• Registration Number: NCT02726347
• Lead Sponsor: National Jewish Health

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.

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-31
• Study Start: 2016-04
• Study First Posted: 2016-04-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-14
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COPD subjects	PPV-23	COPD subjects between the age of 19 and 80, without history of recurrent bacterial infections.
elderly individuals (over age 50)	PPV-23	elderly individuals, defined as subjects age 50 years or older, without a history of frequent infections, COPD, or asthma
Subjects with recurrent bacterial infections	PPV-23	Individuals between the age of 19 and 80 who have a history of frequent bacterial infections and are being evaluated for humoral immunodeficiency
Smokers between the ages of 19-80	PPV-23	current smokers between the ages of 19 and 80
Asthmatics subjects	PPV-23	Asthmatics between the ages of 19 and 80

Primary Outcome Measures

Name	Time	Method
Change from pre-to post-vaccination antibody titer	day one- day of vaccine and one month later	Evaluate the immune response in the 5 groups of subjects

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States