Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients

Part of paid clinical trials in Sacramento, California.

Sponsor: University of California, Davis
Study ID: NCT02232191
Phase: PHASE2
Status: Recruiting

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Conditions

Asplenia

Eligibility Criteria

Sex: ALL
Age: 18 Years - 65 Years
Healthy Volunteers: Not accepted

Interventions

Pneumovax-23 — BIOLOGICAL

Study Details

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.

Key Dates

Start date: Dec 31, 2014
Status verified: Dec 2025
Primary completion: Jul 31, 2026
Completion: Jul 31, 2026

Study Design

Enrollment: 75 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

David V Shatz, MD
916-734-5535
[email protected]
Anthony Calabro, PhD
916-734-4365
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
University of California, Davis Medical Center	Sacramento	California	95817	David V Shatz, MD [email protected]

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By research site

University of California, Davis Medical Center· Sacramento, CA