Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial

Author:

Hassanzadeh Hamid1,Baber James2,Begier Elizabeth3ORCID,Noriega David C4,Konishi Hiroaki5,Yato Yoshiyuki6,Wang Michael Y7,Le Huec Jean Charles8,Patel Vikas9,Varga Peter10,Liljenqvist Ulf11,Conly John12,Sabharwal Charu3,Munjal Iona3,Cooper David3,Radley David3,Jaques Anna2,Patton Michael13,Gruber William C3,Jansen Kathrin U3,Anderson Annaliesa S3,Gurtman Alejandra3,Zenilman Jonathan,Salata Robert,Schaffner William,Blackwelder William,Leaper David,

Affiliation:

1. Department of Orthopaedic Surgery, Johns Hopkins University , Baltimore, Maryland , USA

2. Pfizer Inc, Vaccine Clinical Research , Sydney, New South Wales , Australia

3. Pfizer Inc, Vaccine Research , Pearl River, New York , USA

4. Department of Orthopaedics, Hospital Universitario de Valladolid , Valladolid , Spain

5. Department of Orthopaedic Surgery, Nagasaki Rosai Hospital , Nagasaki , Japan

6. National Hospital Organization Murayama Medical Center, Orthopedics and Sports Medicine Neurosciences & Neurology Surgery , Tokyo , Japan

7. Neurological Surgery, University of Miami , Miami, Florida , USA

8. Department of Orthopaedic and Traumatology, Polyclinique Bordeaux Nord Aquitaine, Bordeaux University , Bordeaux , France

9. Department of Orthopaedic Surgery, University of Colorado School of Medicine , Denver, Colorado , USA

10. National Center for Spinal Disorders, Buda Health Center, Spine Center , Budapest , Hungary

11. Department of Orthopaedic Surgery, St. Franziskus-Hospital Munster Orthopaedie II , Muenster , Germany

12. Department of Medicine, Foothills Medical Centre, Alberta Health Services and University of Calgary , Calgary, Alberta , Canada

13. Pfizer Ltd, Vaccine Clinical Research , Hurley , United Kingdom

Abstract

Abstract Background Staphylococcus aureus is a global pathogen that is frequently responsible for healthcare-associated infections, including surgical site infections (SSIs). Current infection prevention and control approaches may be limited, with S. aureus antibiotic resistance remaining problematic. Thus, a vaccine to prevent or reduce S. aureus infection is critically needed. We evaluated the efficacy and safety of an investigational 4-antigen S. aureus vaccine (SA4Ag) in adults undergoing elective open posterior spinal fusion procedures with multilevel instrumentation. Methods In this multicenter, site-level, randomized, double-blind trial, patients aged 18–85 years received a single dose of SA4Ag or placebo 10–60 days before surgery. SA4Ag efficacy in preventing postoperative S. aureus bloodstream infection and/or deep incisional or organ/space SSIs was the primary end point. Safety evaluations included local reactions, systemic events, and adverse events (AEs). Immunogenicity and colonization were assessed. Results Study enrollment was halted when a prespecified interim efficacy analysis met predefined futility criteria. SA4Ag showed no efficacy (0.0%) in preventing postoperative S. aureus infection (14 cases in each group through postoperative day 90), despite inducing robust functional immune responses to each antigen compared with placebo. Colonization rates across groups were similar through postoperative day 180. Local reactions and systemic events were mostly mild or moderate in severity, with AEs reported at similar frequencies across groups. Conclusions In patients undergoing elective spinal fusion surgical procedures, SA4Ag was safe and well tolerated but, despite eliciting substantial antibody responses that blocked key S. aureus virulence mechanisms, was not efficacious in preventing S. aureus infection. Clinical Trials Registration. NCT02388165.

Funder

Pfizer

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

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