Investigating vaccine response in patients with spleen injuries
Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
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 |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT02232191 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult trauma patients aged 18 to 65 who have sustained a splenic injury.
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.
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 performed: Other studies have shown varying success in vaccine responses among asplenic patients, but this specific approach is novel.
Eligibility criteria
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65 * Initial planned nonoperative management patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study.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 this trial is running
Sacramento, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.