Investigating vaccine response in patients with spleen injuries
Official title: Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
Run by University of California, Davis · NCT02232191 · Data updated 2026-11-12
This study is testing how well a pneumonia vaccine works in adults with spleen injuries who are treated in different ways to see if their treatment affects their immune response.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Status | Recruiting |
| Started | December 2014 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT02232191 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult trauma patients aged 18 to 65 who have sustained a splenic injury.
✕Probably not a fit
Patients outside the age range of 18 to 65 or those who undergo splenectomy or embolization after initial nonoperative management will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines the immune response to the pneumococcal polysaccharide vaccine in adult trauma patients who have sustained splenic injuries. It is a multi-institutional, prospective trial primarily conducted at the University of California, Davis Medical Center, involving three treatment arms: nonoperative management, angioembolization, and splenectomy. A total of 75 subjects will be enrolled, with 25 participants in each arm, to assess how different management strategies affect vaccine efficacy. Blood samples will be collected to analyze antibody levels following vaccination.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies and improve infection prevention in patients without a spleen.
How similar studies have gone: Other studies have shown varying success in vaccine responses among asplenic patients, but this specific approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury. Exclusion Criteria: * 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.
Where it's running
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University of California, Davis Medical Center
Sacramento, California, United States Recruiting
Study contacts
- Principal investigator: David Shatz, MD — University of California, Davis
- Study coordinator: David V Shatz, MD
- Email: dvshatz@ucdavis.edu
- Phone: 916-734-5535
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Italian questionnaire to measure knowledge and vaccination attitudes in people without a spleen
This project will test a new Italian questionnaire to measure how much people without a spleen know about infection prevention and vaccination.
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Education to prevent infections after spleen removal
See if a targeted educational program for adults who had their spleen removed improves vaccination uptake, awareness of infection risk, and continuity of care.
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Assessing risks in patients without a spleen in France
This study looks at patients without a spleen to see what health risks they face and how to better manage their care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.