STRIVE
Trial question
What is the effect of a four-antigen S. aureus vaccine in patients undergoing elective spinal fusion surgical procedures?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 3450
3450 patients (1907 female, 1543 male).
Inclusion criteria: patients aged 18-85 years scheduled to undergo elective spinal fusion surgical procedures.
Key exclusion criteria: surgical indication of malignancy; infection, or acute or emergency trauma; major surgery within 3 months prior to enrollment; spinal surgery performed within 6 months prior to study enrollment; congenital or acquired immunodeficiency disorder.
Interventions
N=1726 S. aureus four-antigen vaccine (four-antigen S. aureus vaccine 10-60 days before surgery).
N=1724 placebo (sterile water injection 10-60 days before surgery).
Primary outcome
Rate of postoperative Staphylococcus aureus bloodstream infection and/or deep incisional or organ/space surgical site infection within day 90
0.9%
0.9%
0.9 %
0.7 %
0.5 %
0.2 %
0.0 %
Staphylococcus aureus four-antigen
vaccine
Placebo
No significant
difference ↔
No significant difference in the rate of postoperative S. aureus bloodstream infection and/or deep incisional or organ/space surgical site infection within day 90 (0.9% vs. 0.9%).
Secondary outcomes
No significant difference in S. aureus blood stream infection (0.5% vs. 0.7%; VE 36.4, 95% CI -79.8 to 79.1).
No significant difference in S. aureus deep incisional or organ/space surgical site infection (0.8% vs. 0.8%).
No significant difference in S. aureus surgical site infection (1.6% vs. 1.4%; VE -9.1, 95% CI -104.1 to 41.4).
Safety outcomes
No significant differences in adverse events, systemic events.
Conclusion
In patients aged 18-85 years scheduled to undergo elective spinal fusion surgical procedures, S. aureus four-antigen vaccine was not superior to placebo with respect to the rate of postoperative S. aureus bloodstream infection and/or deep incisional or organ/space surgical site infection within day 90.
Reference
Hamid Hassanzadeh, James Baber, Elizabeth Begier et al. Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STRIVE Randomized Clinical Trial. Clin Infect Dis. 2023 Jul 26;77(2):312-320.
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