Recruiting
Phase 2

Pneumococcal Vaccine

Sponsor:

UCLA

Code:

NCT02232191

Conditions

Asplenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Pneumovax-23

Study Details

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.

Conditions

Asplenia

Study ID

NCT02232191

Start date

Dec, 2014

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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  • Initial planned nonoperative management patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Nonoperative

Pneumococcal 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.

active comparator: Angioembolization

Pneumococcal 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.

active comparator: Splenectomy

Pneumococcal 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

Pneumovax-23

Primary outcome measure

  • Geometric mean increases in pneumococcal antibody titer [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

David V Shatz, MD

916-734-5535dvshatz@ucdavis.edu

Anthony Calabro, PhD

916-734-4365arcalabro@ucdavis.edu

Locations

University of California, Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

David V Shatz, MD

dvshatz@ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-08-18.