We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pneumococcal Adult-dose Ranging Immunization Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00169234
First Posted: September 15, 2005
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Kaiser Permanente
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
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 Kaiser Permanente:

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 ]

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. ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years to 79 Years   (Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169234


Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Kaiser Permanente
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Lisa A Jackson, MD, MPH Kaiser Permanente
  More Information

Publications:
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00169234     History of Changes
Other Study ID Numbers: CDC Protocol 3848
CDC Task Order 0957-045 ( Other Grant/Funding Number: Centers for Disease Control )
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Kaiser Permanente:
Pneumococcal disease
Vaccination
Immunization
PPV23
PCV7

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs