Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
2 other identifiers
interventional
75
1 country
1
Brief Summary
Persons without a spleen are susceptible to potentially lethal infections from certain bacteria, with pneumococcus being the most prevalent. Vaccines are provided to help protect against these infections, though they do not so with certainty. Trauma patients who sustain an injury to their spleen currently have three treatment options available for the treating surgeon - nonoperative management, embolization, or removal of the spleen. The purpose of this study is to investigate the antibody response to pneumococcal vaccine in patients undergoing these modes of therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2014
Longer than P75 for phase_2
1 active site
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
First Submitted
Initial submission to the registry
September 2, 2014
CompletedFirst Posted
Study publicly available on registry
September 5, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
December 5, 2025
December 1, 2025
11.6 years
September 2, 2014
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Geometric mean increases in pneumococcal antibody titer
measured by opsonophagocytosis assay
4 weeks
Study Arms (3)
Nonoperative
ACTIVE COMPARATORPneumococcal vaccine (Pneumovax-23) will be administered within 72 hours of injury. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.
Angioembolization
ACTIVE COMPARATORPneumococcal vaccine (Pneumovax-23) will be administered 14 days after embolization. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.
Splenectomy
ACTIVE COMPARATORPneumococcal vaccine (Pneumovax-23) will be administered 14 days after splenectomy. Baseline antibody levels will be drawn at the time of vaccine administration, with response levels being drawn 4 weeks later.
Interventions
Eligibility Criteria
You may qualify if:
- Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury.
You may not qualify if:
- Ages less than 18 and greater than 65
- Initial planned nonoperative management patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Davis Medical Center
Sacramento, California, 95817, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
David Shatz, MD
University of California, Davis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2014
First Posted
September 5, 2014
Study Start
December 1, 2014
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
December 5, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share