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PPV: Pneumococcal Polysaccharide Vaccine in Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Aging (NIA) )
ClinicalTrials.gov Identifier:
NCT00239694
First received: October 13, 2005
Last updated: August 2, 2012
Last verified: August 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunogenicity of Pneumococcal Vaccination and Revaccination in Older Adults

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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 ]

Enrollment: 100
Study Start Date: April 2001
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Previously vaccinated
Biological: Pneumococcal Vaccine
One time preventative vaccine
Other Name: Pneumovax
Experimental: 2
Never vaccinated
Biological: Pneumococcal Vaccine
One time preventative vaccine
Other Name: Pneumovax
Biological: Meningococcal Vaccine
One time preventative vaccine
Other Name: Menomune

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
National Institute on Aging
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Investigators
Principal Investigator: Dan L. Longo, MD Scientific Director, National Insitute on Aging