Actively Recruiting
Immunologic Response to Pneumococcal Polysaccharide Vaccine in Patients with Splenic Injury
Led by University of California, Davis · Updated on 2025-12-05
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the immune system responds to pneumococcal vaccination in adults who have suffered injuries to their spleen. These patients are vulnerable to serious infections, especially from pneumococcus bacteria. The study aims to compare antibody responses following different treatments for splenic injury, including nonoperative management, splenic artery embolization, and removal of the spleen (splenectomy). Participants receive the Pneumovax-23 vaccine at different times depending on their treatment group: within 72 hours after injury for nonoperative cases, and 14 days after either embolization or splenectomy. Blood samples are taken at vaccination and again four weeks later to measure levels of antibodies against pneumococcal bacteria. Imaging and other evaluations are used to assess the spleen's condition after embolization. During the study, participants have blood drawn to analyze antibody levels using specific laboratory tests. Those treated with embolization undergo a CT scan three to five days after the procedure to assess spleen viability. Researchers measure changes in antibody levels and compare them with factors like treatment type and spleen condition. The study expects to last until July 2026, with careful monitoring throughout the process.
CONDITIONS
Brief Title
Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult trauma patients aged 18 to 65 years
- Sustained a splenic injury
- Planned for nonoperative management, embolization, or splenectomy
You will not qualify if you...
- Younger than 18 or older than 65 years
- Patients initially planned for nonoperative management who later undergo embolization or splenectomy will be withdrawn from the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants receive the Pneumococcal polysaccharide vaccine (Pneumovax-23) according to their treatment arm and have baseline antibody levels drawn at the time of vaccination.
1 vaccination visit with baseline blood draw
Duration - 4 weeks after vaccination
Participants return for a follow-up blood draw 4 weeks after vaccination to measure antibody response to the vaccine.
1 follow-up visit with blood draw
Trial Site Locations
Total: 1 location
1
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
D
David V Shatz, MD
A
Anthony Calabro, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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