Investigational 4-Antigen Staphylococcus aureus vaccine fails to prevent infections in spinal surgery

Researchers explained the study background and said that Staphylococcus aureus is responsible for healthcare-associated infections. It is a global pathogen frequently associated with surgical site infections (SSIs).

The approaches to infection prevention and control approaches still need to be improved. Antibiotic resistance poses a serious challenge. There is an urgent need for a vaccine that can prevent or reduce S aureus infection.

Considering this background, researchers evaluated the efficacy and safety of an investigational 4-antigen S aureus vaccine (SA4Ag) in adults undergoing elective open posterior spinal fusion procedures requiring multilevel instrumentation. It was a site-level, randomized, double-blind trial including subjects aged 18-85 years single dose of SA4Ag or placebo 10-60 days before surgery. The primary endpoint was the SA4Ag efficacy in preventing postoperative S aureus bloodstream infection or deep incisional or organ/space SSI. Safety evaluations included local reactions, systemic events, and adverse events (AEs). Immunogenicity and colonization were assessed.

The summary of the research is as follows:

• The Study enrollment was halted when a prespecified interim efficacy analysis met predefined futility criteria.
• SA4Ag was not efficacious in preventing postoperative S aureus infection.
• There were similar Colonization rates across groups through postoperative Day 180.
• Mild to moderate Local reactions and systemic events were recorded.
• The frequencies of Adverse events were similar in the groups.

Concluding further, SA4Ag was safe and well tolerated. Though it elicited antibody responses that blocked key S aureus virulence mechanisms, it was ineffective in preventing S aureus infection in those undergoing spinal fusion procedures.

Further reading:

Hassanzadeh H, Baber J, Begier E, Noriega DC, Konishi H, Yato Y, Wang MY, Le Huec JC, Patel V, Varga P, Liljenqvist U, Conly J, Sabharwal C, Munjal I, Cooper D, Radley D, Jaques A, Patton M, Gruber WC, Jansen KU, Anderson AS, Gurtman A; STRIVE Investigator Team. Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STRIVE Randomized Clinical Trial. Clin Infect Dis. 2023 May 1:ciad218. doi: 10.1093/cid/ciad218.