Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial Article Swipe
Hamid Hassanzadeh
,
James Baber
,
Elizabeth Begier
,
David C. Noriega
,
Hiroaki Konishi
,
Yoshiyuki Yato
,
Michael Y. Wang
,
Jean Charles Le Huec
,
Vikas V. Patel
,
Péter Varga
,
Ulf Liljenqvist
,
John Conly
,
Charu Sabharwal
,
Iona Munjal
,
David Cooper
,
David Radley
,
Anna Jaques
,
Michael A. Patton
,
William C. Gruber
,
Kathrin U. Jansen
,
Annaliesa S. Anderson
,
Alejandra Gurtman
,
Jonathan M. Zenilman
,
Robert A. Salata
,
William Schaffner
,
William C. Blackwelder
,
David Leaper
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1093/cid/ciad218
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1093/cid/ciad218
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.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1093/cid/ciad218
- https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciad218/50149648/ciad218.pdf
- OA Status
- hybrid
- Cited By
- 26
- References
- 38
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4367601222
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4367601222Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1093/cid/ciad218Digital Object Identifier
- Title
-
Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical TrialWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2023Year of publication
- Publication date
-
2023-05-01Full publication date if available
- Authors
-
Hamid Hassanzadeh, James Baber, Elizabeth Begier, David C. Noriega, Hiroaki Konishi, Yoshiyuki Yato, Michael Y. Wang, Jean Charles Le Huec, Vikas V. Patel, Péter Varga, Ulf Liljenqvist, John Conly, Charu Sabharwal, Iona Munjal, David Cooper, David Radley, Anna Jaques, Michael A. Patton, William C. Gruber, Kathrin U. Jansen, Annaliesa S. Anderson, Alejandra Gurtman, Jonathan M. Zenilman, Robert A. Salata, William Schaffner, William C. Blackwelder, David LeaperList of authors in order
- Landing page
-
https://doi.org/10.1093/cid/ciad218Publisher landing page
- PDF URL
-
https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciad218/50149648/ciad218.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
hybridOpen access status per OpenAlex
- OA URL
-
https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciad218/50149648/ciad218.pdfDirect OA link when available
- Concepts
-
Medicine, Staphylococcus aureus, Adverse effect, Randomized controlled trial, Placebo, Internal medicine, Clinical trial, Surgery, Pathology, Biology, Bacteria, Alternative medicine, GeneticsTop concepts (fields/topics) attached by OpenAlex
- Cited by
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26Total citation count in OpenAlex
- Citations by year (recent)
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2025: 14, 2024: 11, 2023: 1Per-year citation counts (last 5 years)
- References (count)
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38Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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