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

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Staphylococcal Vaccine	Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine; Other: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	6000 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	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
Actual Study Start Date :	July 2, 2015
Estimated Primary Completion Date :	August 16, 2019
Estimated Study Completion Date :	August 16, 2019

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: SA4Ag; Staphylococcus aureus 4-antigen Vaccine	Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine; SA4Ag vaccine reconstituted in 0.5mL water for injection. Administered via IM injection, once 10 to 60 days prior to surgery; Other Name: Vaccine
Placebo Comparator: Placebo; Diluent (sterile water) for Placebo	Other: Placebo; Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery

Outcome Measures

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Primary Outcome Measures :

1. Subjects in each vaccine group with postoperative S aureus BSI and/or deep incisional or organ/space SSI occurring within 90 days of elective open posterior spinal fusion procedures with multilevel instrumentation [ Time Frame: 90 DAYS after surgery ]
2. Safety and tolerability of a single vaccination of SA4Ag in adults aged 18 to <86 years undergoing elective open posterior spinal fusion procedures with multilevel instrumentation, by measuring local reactions, systemic events, and AEs. [ Time Frame: Up to 8 months after vaccination ]

Secondary Outcome Measures :

1. Subjects in each vaccine group with postoperative S. aureus BSI and/or deep incisional or organ/space surgical site infections occurring within 180 days of elective open posterior spinal fusion procedures with multilevel instrumentation [ Time Frame: 180 days after surgery ]
2. Subjects in each vaccine group with postoperative S. aureus surgical site infections occurring within 90 days of elective open posterior spinal fusion procedures with multilevel instrumentation. [ Time Frame: 90 days after surgery ]
3. Subjects in each vaccine group with postoperative S. aureus surgical site infections occurring within 180 days of elective open posterior spinal fusion procedures with multilevel instrumentation. [ Time Frame: 180 days after surgery ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Pfizer CT.gov Call Center	1-800-718-1021	ClinicalTrials.gov_Inquiries@pfizer.com

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Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT02388165 History of Changes
Other Study ID Numbers:	B3451002; 2014-002644-40 ( EudraCT Number ); 6123K1-2001 ( Other Identifier: Alias Study Number ); STRIVE ( Other Identifier: Alias Study Number )
First Posted:	March 13, 2015
Last Update Posted:	April 17, 2018
Last Verified:	April 2018

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Pfizer:

Staphylococcal Vaccine; Post-operative Surgical Site Infection; Spinal Surgery; MRSA; Staphylococcus aureus

Additional relevant MeSH terms:

Vaccines; Immunologic Factors; Physiological Effects of Drugs