Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation



Status:Active, not recruiting
Healthy:No
Age Range:18 - 85
Updated:2/28/2019
Start Date:July 2, 2015
End Date:June 26, 2019

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A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF STAPHYLOCOCCUS AUREUS 4 ANTIGEN VACCINE (SA4AG) IN ADULTS UNDERGOING ELECTIVE OPEN POSTERIOR SPINAL FUSION PROCEDURES WITH MULTILEVEL INSTRUMENTATION

The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent
postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal
fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective
spinal surgery.


Inclusion Criteria:

- Subject must be scheduled to undergo an elective open posterior spinal fusion
procedures with multilevel instrumentation, 10 to 60 days after study vaccination.

- Subject must be available for the entire duration of the study, and able to comply
with scheduled visits, treatment plan, laboratory tests, and other study procedures
including completion of the electronic diary for 10 days after study vaccination.

- Aged 18 to <86 years old

Exclusion Criteria:

- Planned spinal fusion procedure requiring separate operations performed on separate
days (ie, staged procedure).

- Surgical indication of malignancy, infection or acute or emergency trauma.

- History of major surgery within 3 months prior to enrollment, or anticipated major
surgery other than the Index Surgical Procedure between study enrollment and
completion of study participation.

- History of any spinal surgery performed within 6 months prior to study enrollment.

- History of any previous spinal surgery resulting in postoperative BSI or SSI.

- Congenital or acquired immunodeficiency disorder, rheumatologic disorder or other
illness requiring chronic treatment with known immunosuppressant medications,
including monoclonal antibodies within a year of enrollment or the use of systemic
corticosteroids for > 14 days within 30 days prior to enrollment.

- History of leukemia, lymphoma, underlying bone marrow disorder or history of bone
marrow transplant.
We found this trial at
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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185 Cambridge Street
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75 Francis street
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3300 Gallows Road
Falls Church, Virginia 22042
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1200 Moursund Street
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524 South Park Street
Kalamazoo, Michigan 49007
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1800 West Charleston Boulevard
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8700 Beverly Blvd # 8211
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300 Community Drive
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205 East NASA Boulevard #200
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12605 East 16th Avenue
Aurora, Colorado 80045
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Austin, Texas 78705
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Austin, Texas 78758
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4940 Eastern Ave
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1800 Orleans St.
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1215 Lee St
Charlottesville, Virginia 22903
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1653 W. Congress Parkway
Chicago, Illinois 60612
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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2139 Auburn Ave
Cincinnati, Ohio 45219
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200 Hawkins Dr,
Iowa City, Iowa 52242
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46 Harrison Street
Johnson City, New York 13790
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