Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
ConditionAsplenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult trauma patients (aged 18 to 65 years old) sustaining a splenic injury.
Disqualifiers
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Initial planned nonoperative management patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study.
Trial design
Design model
Parallel
Treatments tested in this trial
Pneumovax-23
Biological/Vaccine
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: NonoperativeActive comparator 1 intervention
Group B: AngioembolizationActive comparator 1 intervention
Group C: SplenectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Geometric mean increases in pneumococcal antibody titer
measured by opsonophagocytosis assay
Time frame
4 weeksSponsors and contacts
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Source ClinicalTrials.gov