Pneumococcal Adult-dose Ranging Immunization Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00169234
First received: September 9, 2005
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Pneumonia
Biological: PCV7, Prevnar®
Biological: Pneumovax 23
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 220
Study Start Date: May 2003
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   70 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00169234

Locations
United States, Washington
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Lisa A Jackson, MD, MPH Group Health Cooperative
  More Information

Publications:
Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00169234     History of Changes
Other Study ID Numbers: CDC Protocol 3848, CDC Task Order 0957-045
Study First Received: September 9, 2005
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Group Health Cooperative:
Pneumococcal disease
Vaccination
Immunization
PPV23
PCV7

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 20, 2014