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PPV: Pneumococcal Polysaccharide Vaccine in Older Adults
This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), May 2009
First Received: October 13, 2005   Last Updated: May 28, 2009   History of Changes
Sponsored by: National Institute on Aging (NIA)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00239694
  Purpose

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

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Pre and post vaccination (groups I and II) serum samples [ Time Frame: Day 0, day 28, and 6 months following vaccination and days on each BLSA site visit ] [ Designated as safety issue: No ]

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

Detailed Description:

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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239694

Contacts
Contact: Pat Knighton, RN 410-350-3927 knightonp@grc.nia.nih.gov

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: Dan L. Longo, MD Scientific Director, National Insitute on Aging
  More Information

Publications:
Responsible Party: National Institute on Aging ( Dan L. Longo, MD )
Study ID Numbers: AG0055
Study First Received: October 13, 2005
Last Updated: May 28, 2009
ClinicalTrials.gov Identifier: NCT00239694     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Immune response
Antibody response

Study placed in the following topic categories:
Antibodies
Immunoglobulins

ClinicalTrials.gov processed this record on September 11, 2009