Pneumococcal Adult-dose Ranging Immunization Study
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
2 other identifiers
interventional
220
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2003
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedOctober 13, 2017
October 1, 2017
1.8 years
September 9, 2005
October 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the immunologic response to varying doses of 7-valent pneumococcal conjugate vaccine (PCV7) among older adults.
Pre/post enrollment vaccination, and pre/post 1 year challenge vaccination
Secondary Outcomes (1)
To evaluate the safety to varying doses of 7-valent pneumococcal conjugate vaccine (PCV7) among older adults.
During the 13 month study period.
Study Arms (5)
0.1mL Pneumococcal Conjugate Vaccine
EXPERIMENTALParticipants 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.
0.5mL Pneumococcal Conjugate Vaccine
EXPERIMENTALParticipants 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.
1.0mL Pneumococcal Conjugate Vaccine
EXPERIMENTALParticipants 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.
2.0mL Pneumococcal Conjugate Vaccine
EXPERIMENTALParticipants 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.
0.5mL Pneumococcal Polysacc Vaccine
EXPERIMENTALParticipants 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.
Interventions
Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaiser Permanentelead
- Centers for Disease Control and Preventioncollaborator
Study Sites (2)
Group Health Research Institute
Seattle, Washington, 98101, United States
VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
Related Publications (2)
Jackson LA, Neuzil KM, Nahm MH, Whitney CG, Yu O, Nelson JC, Starkovich PT, Dunstan M, Carste B, Shay DK, Baggs J, Carlone GM. Immunogenicity of varying dosages of 7-valent pneumococcal polysaccharide-protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2007 May 16;25(20):4029-37. doi: 10.1016/j.vaccine.2007.02.062. Epub 2007 Mar 12.
PMID: 17391816RESULTJackson LA, Neuzil KM, Whitney CG, Starkovich P, Dunstan M, Yu O, Nelson JC, Feikin DR, Shay DK, Baggs J, Carste B, Nahm MH, Carlone G. Safety of varying dosages of 7-valent pneumococcal protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2005 May 25;23(28):3697-703. doi: 10.1016/j.vaccine.2005.02.017.
PMID: 15882530RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lisa A Jackson, MD, MPH
Kaiser Permanente
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
May 1, 2003
Primary Completion
February 1, 2005
Study Completion
February 1, 2005
Last Updated
October 13, 2017
Record last verified: 2017-10