Evidence map›Paper›PMID 38274114›Full record

ArticleEClinicalMedicine2024

A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 results.

Christian Schoergenhofer, Georg Gelbenegger, Dzenita Hasanacevic, Léa Schöner, Margarete M Steiner, Christa Firbas, Nina Buchtele, Ulla Derhaschnig, Andreas Tanzmann, Nina Model and 5 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in EClinicalMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06719219 (A Phase I, Randomized, Double-Blinded and Controlled Trial to Evaluate Safety and Immunogenicity of an Investigational Multicomponent Staphylococcus Aureus Toxoid Vaccine), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.1field-weighted citation impact, top 9% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT06719219 phase1completednot on this mapstarted 2025, after this paper: background citation

A Phase I, Randomized, Double-Blinded and Controlled Trial to Evaluate Safety and Immunogenicity of an Investigational Multicomponent Staphylococcus Aureus Toxoid Vaccine (LTB-SA7) in Healthy Adults.

TypeinterventionalSponsorLimmaTech Biologics AGRan2025 to 2026Enrolled129ConditionsStaphylococcus (S.) Aureus InfectionArmsLTB-SA7, Placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Tracking Canada's 2015 vaccine research and development priorities: Where are we a decade later?Canada communicable disease report = Releve des maladies transmissibles au Canada · 2026
    Article
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 2 institutions in 1 country.

Christian SchoergenhoferDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Georg GelbeneggerDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Dzenita HasanacevicBiomedizinische Forschung & Bio-Produkte AG, Vienna, Austria.
Léa SchönerBiomedizinische Forschung & Bio-Produkte AG, Vienna, Austria.
Margarete M SteinerDivision of General Anesthesia and Intensive Care Medicine, Department of Anesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.
Christa FirbasDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Nina BuchteleDivision of Medicine I, Intensive Care Unit 13i2, Medical University of Vienna, Vienna, Austria.
Ulla DerhaschnigDepartment of Emergency Medicine, Medical University of Vienna, Vienna, Austria.
Andreas TanzmannDepartment of Blood Group Serology and Transfusion Medicine, Medical University of Vienna, Vienna, Austria.
Nina ModelBiomedizinische Forschung & Bio-Produkte AG, Vienna, Austria.
Julian Larcher-SennAssign Data Management and Biostatistics GmbH, Innsbruck, Austria.
Manuel DrostAssign Data Management and Biostatistics GmbH, Innsbruck, Austria.
Martha M EiblBiomedizinische Forschung & Bio-Produkte AG, Vienna, Austria.
Andreas RoetzerBiomedizinische Forschung & Bio-Produkte AG, Vienna, Austria.
Bernd JilmaDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Medical University of Vienna · ATBioforschung Austria · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Toxic shock syndrome toxin-1 (TSST-1) is a superantigen produced by Methods: In this randomised, double-blind, adjuvant-controlled, parallel-group, phase 2 trial, healthy adults aged 18-64 were randomly allocated to undergo 1-3 injections of either 10 or 100 μg rTSST-1v or Al(OH) Findings: Between April and November 2017,140 subjects were enrolled and 126 completed the trial. rTSST-1v showed a good safety and tolerability profile. A total of 855 systemic adverse events occurred, 280 of which were suspected related adverse events, without dose dependency. Two participants were discontinued early because of allergic reactions. Seroconversion occurred in >81% of subjects within 3 months of the first immunisation which was sustained until 18 months after the third immunisation in over 70% of subjects in the pooled low-dose group and in over 85% in the pooled high-dose group. Interpretation: rTSST-1v in cumulative doses of up to 300 μg was safe, well-tolerated and highly immunogenic. Two immunisations with 100 μg rTSST-1v provided the most persistent immune response and may be evaluated in future trials. Funding: Biomedizinische Forschung & Bio-Produkte AG funded this study.

Indexed as

Staphylococcus aureusSuperantigenToxic shock syndromeTSST-1Vaccine

Identifiers

PMID38274114
PMCPMC10808908
OpenAlexW4390605616

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.