PPV: Pneumococcal Polysaccharide Vaccine in Older Adults

July 14, 2015 updated by: National Institute on Aging (NIA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • National Institute on Aging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Previously vaccinated
Biological: Pneumococcal Vaccine
One time preventative vaccine
Other Names:
  • Pneumovax
EXPERIMENTAL: 2
Never vaccinated
Biological: Pneumococcal Vaccine
One time preventative vaccine
Other Names:
  • Pneumovax
Biological: Meningococcal Vaccine
One time preventative vaccine
Other Names:
  • Menomune

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 0, day 28, and 6 months following vaccination and days on each BLSA site visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Dan L. Longo, MD, Scientific Director, National Insitute on Aging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

October 13, 2005

First Submitted That Met QC Criteria

October 13, 2005

First Posted (ESTIMATE)

October 17, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2015

Last Update Submitted That Met QC Criteria

July 14, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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