Trial reportHuman vaccines & immunotherapeutics2015
Efficacy profile of a bivalent Staphylococcus aureus glycoconjugated vaccine in adults on hemodialysis: Phase III randomized study.
Trial report in Human vaccines & immunotherapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00071214 (A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis), which is not on this map. Cited by 79 papers.
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 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis
Who cites it
79 citing papers in PubMed, 132 citations in OpenAlex.
- 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
- Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Trial
- High Titer Persistent Neutralizing Antibodies Induced by TSST-1 Variant Vaccine Against Toxic Shock Cytokine Storm.Toxins · 2020Trial
- Role and plasticity of Th1 and Th17 responses in immunity toHuman vaccines & immunotherapeutics · 2019Trial
- Safety and immunogenicity of an investigational 4-component Staphylococcus aureus vaccine with or without AS03B adjuvant: Results of a randomized phase I trial.Human vaccines & immunotherapeutics · 2015Trial
- Chemical Synthesis of Pseudomonas aeruginosa, Staphylococcus aureus, and Acinetobacter baumannii Capsular Polysaccharide Fragments as Leads for Cross-Protection.Angewandte Chemie (International ed. in English) · 2026Article
- Structure of ClfA002 in Complex With Neutralizing Antibody AZD7745 Provides Insight into Its Broad Neutralization Mechanism in Staphylococcus aureus Infection.The Journal of infectious diseases · 2025Article
- The Central Importance of Vaccines to Mitigate the Threat of Antibiotic-Resistant Bacterial Pathogens.Vaccines · 2025Review
- A promisingClinical and experimental vaccine research · 2025Review
- Healthcare-Associated Infections: The Role of Microbial and Environmental Factors in Infection Control-A Narrative Review.Infectious diseases and therapy · 2025Review
- Protection of Mice Vaccinated with a New B Cell and T Cell Epitopes Cocktail from Staphylococcus aureus Challenge in Skin Infection Model.Current microbiology · 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
- A rationally designed antigen elicits protective antibodies against multiple nosocomial Gram-positive pathogens.NPJ vaccines · 2024Article
- Use of Transcriptional Signatures to Differentiate Pathogen-Specific and Treatment-Specific Host Responses in Patients With Bacterial Bloodstream Infections.The Journal of infectious diseases · 2024Article
- Distinct T cell signatures are associated with Staphylococcus aureus skin infection in pediatric atopic dermatitis.JCI insight · 2024Article
- Reverse development of vaccines against antimicrobial-resistant pathogens.NPJ vaccines · 2024Review
- Molecular Aspects of the Functioning of Pathogenic Bacteria Biofilm Based onInternational journal of molecular sciences · 2024Review
- Toxin-neutralizing Abs are associated with improved T cell function following recovery from Staphylococcus aureus infection.JCI insight · 2024Article
- Dry and liquid formulations of IBT-V02, a novel multi-component toxoid vaccine, are effective againstFrontiers in immunology · 2024Article
19 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In a previous study in end-stage renal disease (ESRD) hemodialysis patients, a single dose of Staphylococcus aureus type 5 and 8 capsular polysaccharides (T5/T8) conjugated to nontoxic recombinant Pseudomonas aeruginosa exotoxin A investigational vaccine showed no efficacy against S. aureus bacteremia 1 year post-vaccination, but a trend for efficacy was observed over the first 40 weeks post-vaccination. Vaccine efficacy (VE) of 2 vaccine doses was therefore evaluated. In a double-blind trial 3359 ESRD patients were randomized (1:1) to receive vaccine or placebo at week 0 and 35. VE in preventing S. aureus bacteremia was assessed between 3-35 weeks and 3-60 weeks post-dose-1. Anti-T5 and anti-T8 antibodies were measured. Serious adverse events (SAEs) were recorded for 42 days post-vaccination and deaths until study end. No significant difference in the incidence of S. aureus bacteremia was observed between vaccine and placebo groups between weeks 3-35 weeks post-dose 1 (VE -23%, 95%CI: -98;23, p = 0.39) or at 3-60 weeks post-dose-1 (VE -8%, 95%CI: -57;26, p = 0.70). Day 42 geometric mean antibody concentrations were 272.4 μg/ml and 242.0 μg/ml (T5 and T8, respectively) in vaccinees. SAEs were reported by 24%/25.3% of vaccinees/placebo recipients. These data do not show a protective effect of either 1 or 2 vaccine doses against S. aureus bacteremia in ESRD patients. The vaccine induced a robust immune response and had an acceptable safety profile. Further investigation suggested possible suboptimal vaccine quality (manufacturing) and a need to expand the antigen composition of the vaccine. This study is registered at www.clinicaltrials.gov NCT00071214.
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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.