Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2023
Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02388165 (A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF STAPHYLOCOCCUS AUREUS 4 ANTIGEN VACCINE), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A phase 2b, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of staphylococcus aureus 4 antigen vaccine (sa4ag) in adults undergoing elective open posterior spinal fusion procedures with multilevel instrumentation
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.
- The evolving landscape ofFrontiers in immunology · 2026Pooled it
- Safety, Efficacy, and Immunogenicity of a Multivalent Adjuvanted Staphylococcus aureus Vaccine in Adults With Recent Skin and Soft Tissue Infections: An Observer-Blind, Randomized, Placebo-Controlled, Multinational Phase 1/2 Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026Trial
- Emerging therapies and diagnostic innovations for multidrug-resistant infections in kidney allograft recipients: Challenges and future directions.World journal of nephrology · 2026Review
- Design of a multi-epitope Staphylococcus aureus vaccine integrating a protein A variant, α-hemolysin, and fibronectin-binding protein A through reverse vaccinology.Scientific reports · 2026Article
- Multivalent nanobodies for potent and broad neutralization of Staphylococcus aureus toxins.Nature communications · 2026Article
- Conserved CD4Nature microbiology · 2026Article
- Managing Bone Infections Beyond Systemic Antibiotics: A Scoping Review.Pathogens (Basel, Switzerland) · 2026Review
- Methicillin-resistant and susceptible Staphylococcus aureus: tolerance, immune evasion and treatment.Nature reviews. Microbiology · 2026Review
- Taming Superbugs: Current Progress and Challenges in Combating ESKAPE Pathogens.Pathogens (Basel, Switzerland) · 2025Review
- Scaffold vaccination for prevention of orthopedic device infection.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Overcoming Immune Evasion inACS infectious diseases · 2025Review
- The Influence of Maternal Staphylococcus aureus Anti-Hla Neutralizing Antibody on Infant Skin and Soft Tissue Development in the First Year of Life.Journal of the Pediatric Infectious Diseases Society · 2025Article
- The Central Importance of Vaccines to Mitigate the Threat of Antibiotic-Resistant Bacterial Pathogens.Vaccines · 2025Review
- TheJournal of clinical microbiology · 2025Review
- Healthcare-Associated Infections: The Role of Microbial and Environmental Factors in Infection Control-A Narrative Review.Infectious diseases and therapy · 2025Review
- A SpA+LukAB vaccine targeting Staphylococcus aureus evasion factors restricts infection in two minipig infection models.NPJ vaccines · 2025Article
- The lack of a biorepository during vaccine trials: A lost opportunity to understand staphylococcal immunity.Vaccine · 2025Article
- An integrated subtractive genomics and immunoinformatic approach for designing a multi-epitope peptide vaccine against methicillin-resistantFrontiers in bioinformatics · 2025Article
- Potential Therapeutic Targets for Combination Antibody Therapy AgainstAntibiotics (Basel, Switzerland) · 2024Review
- Vaccines and monoclonal antibodies to prevent healthcare-associated bacterial infections.Clinical microbiology reviews · 2024Review
Corrections and comments
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Authors and funding
23 authors at 12 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundStaphylococcus 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.
methodsIn 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.
resultsStudy 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.
conclusionsIn 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.