PF-06290510 / Pfizer - LARVOL DELTA

Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STRIVE Randomized Clinical Trial. (PubMed, Clin Infect Dis) - P2b | "In patients undergoing elective spinal fusion surgical procedures, SA4Ag was safe, well tolerated, but despite eliciting substantial antibody responses that blocked key S aureus virulence mechanisms, was not efficacious in preventing S aureus infection. ClinicalTrials.gov: NCT02388165."

Clinical • Journal • Surgery • Infectious Disease

Performance of a Four-Antigen Staphylococcus aureus Vaccine in Preclinical Models of Invasive S. aureus Disease. (PubMed, Microorganisms) - "Complete prevention of infection was demonstrated in a clinically relevant endocarditis model. Unfortunately, these positive preclinical findings with SA4Ag did not prove the clinical utility of SA4Ag in the prevention of surgery-associated invasive S. aureus infection."

Journal • Preclinical • Cardiovascular • Infectious Disease • Nephrology • Septic Shock

STRIVE: Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation (clinicaltrials.gov) - P2b; N=3450; Terminated; Sponsor: Pfizer; Completed ➔ Terminated; Study terminated by sponsor

Clinical • Trial termination

Evaluation of a Single Vaccination With a 4-Antigen Staphylococcus Aureus Vaccine (SA4Ag) in Healthy Adults Aged 18 to <65 Years (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Pfizer

New P1 trial • Biosimilar • Immunology

The development of a staphylococcus aureus four antigen vaccine for use prior to elective orthopedic surgery. (PubMed, Hum Vaccin Immunother) - "In this review we discuss the design of SA4Ag, as well as the proposed clinical development plan supporting licensure of SA4Ag for the prevention of invasive disease caused by S. aureus in elective orthopedic surgical populations. We also explore the rationale for the generalizability of the results of the STRIVE efficacy study (patients undergoing elective open posterior multilevel instrumented spinal fusion surgery) to a broad elective orthopedic surgery population due to the common pathophysiology of invasive S. aureus disease and commonalties of patient and procedural risk factors for developing postoperative S. aureus surgical site infections."

Journal

Persistence of Immune Responses Through 36 Months in Healthy Adults After Vaccination With a Novel Staphylococcus aureus 4-Antigen Vaccine (SA4Ag). (PubMed, Open Forum Infect Dis) - P1/2; "Persistent functional immune responses to S. aureus antigens were observed through 36 months in healthy adults. NCT01643941 and NCT01364571."

Clinical • Journal

STRIVE: Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation (clinicaltrials.gov) - P2b; N=3447; Completed; Sponsor: Pfizer; Active, not recruiting ➔ Completed

Clinical • Trial completion

STRIVE: Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation (clinicaltrials.gov) - P2b; N=3447; Active, not recruiting; Sponsor: Pfizer; Recruiting ➔ Active, not recruiting; N=6000 ➔ 3447

Enrollment change • Enrollment closed