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Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02232191
Recruitment Status : Recruiting
First Posted : September 5, 2014
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE September 2, 2014
First Posted Date  ICMJE September 5, 2014
Last Update Posted Date October 18, 2019
Study Start Date  ICMJE December 2014
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
Geometric mean increases in pneumococcal antibody titer [ Time Frame: 4 weeks ]
measured by opsonophagocytosis assay
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
Official Title  ICMJE Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
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.
Detailed Description

The study is a multi-institutional, prospective trial, conducted primarily at the University of California, Davis Medical Center (UCDMC) by the Department of Surgery, Division of Trauma and Acute Care Surgery. The angioembolization arm will be multicenter while the nonoperative group will be enrolled only at UCDMC. There will be a total of 90 subjects, with 30 in each of the three arms (nonoperative, angioembolization, splenectomy).

Adult trauma patients (defined as those aged 18 to 65 years old) sustaining a splenic injury and planned nonoperative management, are eligible for enrollment in the nonoperative arm. The management decision for the splenic injury is entirely at the discretion of the attending trauma surgeon. Any patient who subsequently undergoes embolization or splenectomy will be withdrawn from the study.

Adult trauma patients sustaining a splenic injury and undergoing splenic artery embolization are eligible for enrollment in this arm of the study. The management decision for the splenic injury is entirely at the discretion of the attending trauma surgeon and radiologist. All patients undergoing successful splenic artery embolization (no subsequent splenectomy or splenorrhaphy, i.e., no cross-over) are eligible.

Patients managed nonoperatively will be vaccinated within three days of their diagnosis, per standard operating protocol at UCDMC. At the time of vaccination, 7cc of venous blood will be collected for baseline antibody analysis. Patients will return four weeks later for a follow-up phlebotomy of another 7cc of blood for analysis of functional antipneumococcal antibody generated in response to vaccine antigen challenge. Blood samples will be centrifuged and stored, and stored sera will be sent in batches on dry ice to Flow Applications, Inc. in McDonough, Georgia for antibody analysis. All samples will be assigned unique patient identifiers.

Responses to the 23-valent pneumococcal polysaccharide vaccine will be measured by ELISA to determine the geometric mean increase in immunoglobulin G (IgG) antibody titer to pneumococcal polysaccharide (Pnc Ps) serotypes. Functional antibody, measured by percent kill of a known pneumococcal concentration, will be determined by opsonophagocytosis assay (OPA). Titers for serogroup 4 and serotypes 6B, 19F, and 23F will be measured, and geometric mean rises in antibody concentrations will be determined to measure response to vaccination.

For those treated with nonoperative management, degree of antibody response and grade of splenic injury will be analyzed against normal controls.

Patients treated via splenic artery embolization will undergo a standard post-embolization computed tomographic exam of the abdomen three to five days postinjury to evaluate the effectiveness of the embolization procedure. The percent of viable, perfused spleen will be calculated from this CT. Antibody response will be compared against the location of the intravascular coils (i.e., proximal versus distal embolization) and the percent of viable spleen as calculated on the follow-up CT scan.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Asplenia
Intervention  ICMJE Biological: Pneumovax-23
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Pneumovax-23
  • 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.
    Intervention: Biological: Pneumovax-23
  • 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.
    Intervention: Biological: Pneumovax-23
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 4, 2014)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David V Shatz, MD 916-734-5535 dvshatz@ucdavis.edu
Contact: Chancey Sweeney, MPA,MHA 916-734-4771 cassweeney@ucdavis.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02232191
Other Study ID Numbers  ICMJE 1036320
51847 ( Other Grant/Funding Number: Merck Investigators Study Program )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Shatz, MD University of California, Davis
PRS Account University of California, Davis
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP