Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00239694
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2005-10-13
Brief Title:
PPV Pneumococcal Polysaccharide Vaccine in Older Adults
Sponsor:
National Institute on Aging NIA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Immunogenicity of Pneumococcal Vaccination and Revaccination in Older Adults
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Streptococcus pneumonia is the leading cause of pneumonia the United States estimated to cause at least 500000 cases annually and 40000 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
1 Specific antipneumococcal antibody will remain above prevaccination level in the serum of healthy older people for up to ten years after PPV
2 Healthy older people will have a prompt and robust vaccine response to primary vaccination with PPV
3 The existence of antipneumococcal antibody in healthy older people who had been vaccinated with PPV 5 years previously will not be associated with more pronounced or frequent adverse events or a reduced vaccine response rate
4 The effect of advanced age will account for a reduced vaccine response
Volunteers in the Baltimore Longitudinal Study of Aging BLSA will be asked to participate in this retrospectiveprospective 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
All volunteers Groups I and II will receive the same vaccines In one arm they will receive PPV for group I this will be revaccination and for group II this will be primary vaccination In the other arm they will receive Meningococcal Polysaccharide Vaccine MPV primary vaccination for both groups I and II
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
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
1 Specific antipneumococcal antibody will remain above prevaccination level in the serum of healthy older people for up to ten years after PPV
2 Healthy older people will have a prompt and robust vaccine response to primary vaccination with PPV
3 The existence of antipneumococcal antibody in healthy older people who had been vaccinated with PPV 5 years previously will not be associated with more pronounced or frequent adverse events or a reduced vaccine response rate
4 The effect of advanced age will account for a reduced vaccine response
Volunteers in the Baltimore Longitudinal Study of Aging BLSA will be asked to participate in this retrospectiveprospective 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
All volunteers Groups I and II will receive the same vaccines In one arm they will receive PPV for group I this will be revaccination and for group II this will be primary vaccination In the other arm they will receive Meningococcal Polysaccharide Vaccine MPV primary vaccination for both groups I and II
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None