Pneumococcal Adult-dose Ranging Immunization Study

October 11, 2017 updated by: Kaiser Permanente

Immunogenicity and Safety of Varying Doses of a 7-valent Conjugate Pneumococcal Vaccine in Adults 70-79 Years of Age Who Were Previously Vaccinated With the 23-valent Pneumococcal Polysaccharide Vaccine

The purpose of this study is to give seniors different doses of a new pneumococcal vaccine called PCV7 to evaluate the safety of the vaccine and compare the immune response to find out which amount gives the best immune response. The PCV7 vaccine is currently licensed by the FDA for use in infants and toddlers only.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this prospective randomized study is to assess the safety, post-vaccination antibody response, and memory response to a subsequent polysaccharide challenge of varying doses of PCV7 compared with the standard dose of PPV23 in immunocompetent adults 70-79 years of age who were previously vaccinated with PPV23 at age 65 years or above and at least 5 years previously. The study will be conducted among a total of 220 persons recruited from GHC and the Seattle VAMC. Participants will be randomized into one of 5 study groups with 44 participants per group. The antigen content of PCV7 will be varied by administration of different volumes of the licensed pediatric formulation of that vaccine. Four groups will receive one of four volumes (0.1 mL, 0.5 mL, 1.0 mL, 2.0 mL) of the licensed pediatric formulation of PCV7 followed 12 months later by administration of a challenge 0.1 mL dose of PPV23 to assess the induction of immunologic memory. The comparison group will receive the standard 0.5 mL dose of PPV23 following 12 months later by administration of a 0.1 mL dose of PPV23.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 2
  • Phase 1

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
    • Washington
      • Seattle, Washington, United States, 98101
        • Group Health Research Institute
      • Seattle, Washington, United States, 98108
        • VA Puget Sound Health Care System

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

66 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 70 through 79 years (up to the day prior to the 80th birthday)
  • Previously received exactly one dose of PPV23, and that dose was received on or after their 65th birthday and at least 5 years before the date of study enrollment
  • Expected to reside in the area for at least 13 months
  • Able to understand and give informed consent
  • Able to perform study procedures
  • Able to be contacted by telephone for follow-up on adverse events

Exclusion Criteria:

  • Received >=2 doses of PPV23 prior to study enrollment.
  • Living non-independently in an institutional setting, such as a nursing home. Persons living independently in adult residence communities will be eligible.
  • Use of any investigational vaccine within the past 30 days or planned use during the study period.
  • Current or planned participation in a research study of an investigational drug. Participation in research studies that involve use of licensed drugs, for either approved or investigational indications, will be permitted with the approval of the site PI, as will participation in research studies that do not involve medications.
  • Current use or previous chronic administration, defined as >=14 days during the previous six months, of immunosuppressants or other immune-modifying drugs. (For oral or injected corticosteroids, the immune-modifying dose is defined as prednisone or its equivalent >=10 mg/day). Topical steroids are allowed.
  • Current use of high doses of inhaled steroids, defined as per Table 3.
  • Use of cytotoxic therapy in the previous 5 years.
  • Plans to receive cytotoxic therapy during the study period.
  • Receipt of parenteral immunoglobulin or blood products within three months of study.
  • Plans to receive parenteral immunoglobulin or blood products within the study period.
  • Current ongoing use of warfarin or heparin or has a bleeding disorder, such as ITP.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • Anatomic or known functional asplenia.
  • History of a hematologic malignancy or a pre-malignant condition (i.e., leukemia, lymphoma, multiple myeloma, myelodysplasia).
  • Active neoplastic disease, excluding local skin cancer or other malignancies (e.g. prostate cancer) that are stable in the absence of immunosuppressive/cytotoxic or radiation therapy.
  • End-stage liver disease or hepatic failure (as diagnosed by a physician or evidenced by a history within the last 10 years of bleeding esophageal varices, ascites, or hepatic encephalopathy).
  • Renal failure, as evidenced by current or expected dialysis or known creatinine of >=2.5 ug/ml.
  • Known hypersensitivity to PPV23 or to any component of PPV23 or PCV7, including aluminum phosphate or diphtheria protein.
  • Presence of any other condition or impairment that in the opinion of the investigator is likely to compromise the participant's ability to complete the study procedures.

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: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.1mL Pneumococcal Conjugate Vaccine
Participants in this group were randomized at enrollment to receive 0.1mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later.
Biological: PCV7, Prevnar®
Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Biological: Pneumovax 23
Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Experimental: 0.5mL Pneumococcal Conjugate Vaccine
Participants in this group were randomized at enrollment to receive 0.5mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later.
Biological: PCV7, Prevnar®
Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Biological: Pneumovax 23
Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Experimental: 1.0mL Pneumococcal Conjugate Vaccine
Participants in this group were randomized at enrollment to receive 1.0mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later.
Biological: PCV7, Prevnar®
Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Biological: Pneumovax 23
Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Experimental: 2.0mL Pneumococcal Conjugate Vaccine
Participants in this group were randomized at enrollment to receive 2.0mL PCV7, Prevnar® at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later.
Biological: PCV7, Prevnar®
Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Biological: Pneumovax 23
Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Experimental: 0.5mL Pneumococcal Polysacc Vaccine
Participants in this group were randomized at enrollment to receive 0.5mL Pneumovax 23 at the enrollment visit and then 0.1mL Pneumococcal Polysaccharide Vaccine 12 months later.
Biological: Pneumovax 23
Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the immunologic response to varying doses of 7-valent pneumococcal conjugate vaccine (PCV7) among older adults.
Time Frame: Pre/post enrollment vaccination, and pre/post 1 year challenge vaccination
Pre/post enrollment vaccination, and pre/post 1 year challenge vaccination

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety to varying doses of 7-valent pneumococcal conjugate vaccine (PCV7) among older adults.
Time Frame: During the 13 month study period.
During the 13 month study period.

Collaborators and Investigators

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

Sponsor

Kaiser Permanente

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Lisa A Jackson, MD, MPH, Kaiser Permanente

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

May 1, 2003

Primary Completion (Actual)

February 1, 2005

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC Protocol 3848
  • CDC Task Order 0957-045 (Other Grant/Funding Number: Centers for Disease Control)

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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