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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00239694 |
The purpose of this study is to measure how long the improvement in the immune system lasts in older people after they have been vaccinated, and to examine the immune response in older people who get vaccinated a second time.
Condition | Intervention | Phase |
---|---|---|
Aging |
Biological: Pneumococcal Vaccine Biological: Meningococcal Vaccine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety Study |
Official Title: | Immunogenicity of Pneumococcal Vaccination and Revaccination in Older Adults |
Estimated Enrollment: | 100 |
Study Start Date: | April 2001 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Previously vaccinated
|
Biological: Pneumococcal Vaccine
One time preventative vaccine
|
2: Experimental
Never vaccinated
|
Biological: Pneumococcal Vaccine
One time preventative vaccine
Biological: Meningococcal Vaccine
One time preventative vaccine
|
Streptococcus pneumonia is the leading cause of pneumonia the United States, estimated to cause at least 500,000 cases annually and 40,000 deaths.
Interest in expanding pneumococcal vaccine administration has arisen with the increased prevalence of antibiotic-resistant S. pneumoniae, increasing numbers of people living with chronic medical conditions, and the aging population.
Extensive studies on vaccine response in older persons have been performed over the past 25 years. However, a number of issues hindered the assessment of vaccine response in older people. Recent studies indicate most healthy older people develop an initial antibody response to vaccination similar to younger cohorts, although antibody response to some serotypes may be less. Limited data suggest functional antibody will develop at least initially after vaccination in older recipients. There are no published reports describing the duration of antibody response or antibody function after revaccination in older patients.
It is difficult to predict the revaccination response and, for those with elevated pre-revaccination antibody, there may be no response to revaccination, or even a lowering of absolute antibody level. Accordingly, a well-controlled revaccination protocol in which older patients with defined vaccine history and known pre-revaccination antibody level are studied for quantitative and qualitative antibody response to revaccination is sorely needed.
The hypotheses for this study are:
Volunteers in the Baltimore Longitudinal Study of Aging (BLSA) will be asked to participate in this retrospective/prospective analysis. Two pools of participants will be recruited. The first group (Group I) will be 65 years and older who had received PPV five or more years earlier, and the second (Group II) will be decade and gender matched individuals with no prior exposure to PPV. These groups will be matched as closely as possible.
Blood samples will be drawn before and after vaccination on day 0 (the day of vaccination), on day 28, and at 6 months following vaccination.
Approximately six months after the last vaccination participants will be asked to complete a brief medical history update, either by telephone, by mail, or during their regularly scheduled BLSA visit. This update will continue to be performed every six months for the duration of the study.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pat Knighton, RN | 410-350-3927 | knightonp@grc.nia.nih.gov |
United States, Maryland | |
National Institute on Aging | Recruiting |
Baltimore, Maryland, United States, 21225 | |
Contact: Pat Knighton, RN 410-350-3927 knightonp@grc.nia.nih.gov | |
Principal Investigator: Dan L. Longo, MD |
Principal Investigator: | Dan L. Longo, MD | Scientific Director, National Insitute on Aging |
Responsible Party: | National Institute on Aging ( Dan L. Longo, MD ) |
Study ID Numbers: | AG0055 |
Study First Received: | October 13, 2005 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00239694 History of Changes |
Health Authority: | United States: Federal Government |
Immune response Antibody response |
Antibodies Immunoglobulins |