PPV: Pneumococcal Polysaccharide Vaccine in Older Adults
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 10/14/2017 |
| Start Date: | April 2001 |
| End Date: | August 2012 |
Immunogenicity of Pneumococcal Vaccination and Revaccination in Older Adults
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.
in older people after they have been vaccinated, and to examine the immune response in older
people who get vaccinated a second time.
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:
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 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.
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.
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:
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 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.
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.
Inclusion Criteria:
- Enrolled in the BLSA with at least 2 stored blood samples post vaccination
- 65 years old or older
- Previously vaccinated with Pneumovax at least 5 years ago or never vaccinated
- Willing to receive vaccination with pneumococcal and meningococcal injection
- Able to provide informed consent
- Has never received a meningococcal vaccine
Exclusion Criteria:
- Hypersensitivity to the pneumococcal or meningococcal vaccine
- Ever received the Meningococcal vaccine
- History of non-skin cancer
- History of myeloproliferative disorder
- History of HIV
- Received a Bone Marrow Transplant
- Taking prednisone (more than 5 mg/day) or other immunosuppressive medication
- Evidence of severe liver or renal disease (serum creatine >2.0 mg/dL or Total
Bilirubin >2.0
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