Last update 21 Nov 2024

Recombinant toxic shock syndrome toxin-1 variant vaccine (Biomedizinische Forschungsgesellschaft)

Last update 21 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

BioMed rTSST1 variant vaccine Biomedizinische Forschungsgesellschaft, rTSST1 variant vaccine Biomedizinische Forschungsgesellschaft

Target-

Mechanism

Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication-

Inactive Indication

Bacterial Infections

Originator Organization

Biomedizinische Forschungsgesellschaft mbH

Active Organization-

Inactive Organization

Biomedizinische Forschungsgesellschaft mbH

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

100 Clinical Results associated with Recombinant toxic shock syndrome toxin-1 variant vaccine (Biomedizinische Forschungsgesellschaft)

100 Translational Medicine associated with Recombinant toxic shock syndrome toxin-1 variant vaccine (Biomedizinische Forschungsgesellschaft)

100 Patents (Medical) associated with Recombinant toxic shock syndrome toxin-1 variant vaccine (Biomedizinische Forschungsgesellschaft)

Literatures (Medical) associated with Recombinant toxic shock syndrome toxin-1 variant vaccine (Biomedizinische Forschungsgesellschaft)

01 Sep 2016·The Lancet Infectious DiseasesQ1 · MEDICINE

Safety, tolerability, and immunogenicity of a recombinant toxic shock syndrome toxin (rTSST)-1 variant vaccine: a randomised, double-blind, adjuvant-controlled, dose escalation first-in-man trial

Q1 · MEDICINE

Article

Author: Eibl, Martha M ; Gruener, Corina S ; Schwameis, Michael ; Stich, Norbert ; Buchtele, Nina ; Roetzer, Andreas ; Model, Nina ; Jilma, Bernd ; Roppenser, Bernhard ; Firbas, Christa

BACKGROUNDStaphylococcal toxic shock syndrome is a superantigen-driven potentially life-threatening disease affecting mainly young and otherwise healthy individuals. Currently, no specific treatment or preventive measure is available. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant detoxified toxic shock syndrome toxin-1 variant (rTSST-1v) vaccine in adult volunteers.METHODSIn this randomised, double-blind, adjuvant-controlled, dose-escalation first-in-human trial, healthy adults aged 18-64 years were enrolled from the Medical University of Vienna, Austria. Participants were randomly assigned (2:1 and 3:1) by block randomisation (block sizes of three and 12) to receive increasing doses of rTSST-1v (100 ng to 30 μg) or the adjuvant comparator aluminium hydroxide (Al(OH)3) (200 μg, 600 μg, or 1 mg). Investigators and participants were masked to group allocation. The per-protocol population received a booster immunisation 42 days after the first vaccination. The primary endpoint was safety and tolerability of rTSST-1v. The per-protocol population included all participants who had adhered to the study protocol without any major protocol deviations. The per-protocol population was the primary analysis population for immunogenicity. The trial is registered with EudraCT, number 2013-003716-50, and ClinicalTrials.gov, number NCT02340338.FINDINGSBetween Aug 19, 2014, and April 14, 2015, 46 participants were enrolled (safety population), of whom three were assigned to cohort 1 (two to receive 100 ng rTSST-1v and one to receive 200 μg Al(OH)3), three to cohort 2 (two to receive 300 ng rTSST-1v and one to receive 600 μg Al(OH)3), four to cohort 3 (three to receive 1 μg rTSST-1v and one to receive 1 mg Al(OH)3), 12 to cohort 4 (nine to receive 3 μg rTSST-1v and three to receive 1 mg Al(OH)3), 12 to cohort 5 (nine to receive 10 μg rTSST-1v and three to receive 1 mg Al(OH)3), and 12 to cohort 6 (nine to receive 300 μg rTSST-1v and three to receive 1 mg Al(OH)3). 45 participants (98%) were included in the per-protocol population. rTSST-1v had a good safety profile, and no vaccination-related severe or serious adverse events occurred. Adverse event rates were similar between participants who received rTSST-1v and those who received placebo (26 [76%] vs 10 [83%]; p=0·62) independent of pre-existing TSST-1 immunity.INTERPRETATIONrTSST-1v was safe, well-tolerated, and immunogenic. This study represents an important step in vaccine development to prevent or treat a potentially lethal disease.FUNDINGBiomedizinische Forschungs GmbH.

PLoS ONEQ3 · CROSS-FIELD

Suppression of Starvation-Induced Autophagy by Recombinant Toxic Shock Syndrome Toxin-1 in Epithelial Cells

Q3 · CROSS-FIELD

ArticleOA

Author: Nakane, Akio ; Ono, Hisaya K ; Asano, Krisana ; Asano, Yoshiya

Toxic shock syndrome toxin-1 (TSST-1), a superantigen produced from Staphylococcus aureus, has been reported to bind directly to unknown receptor(s) and penetrate into non-immune cells but its function is unclear. In this study, we demonstrated that recombinant TSST-1 suppresses autophagosomal accumulation in the autophagic-induced HeLa 229 cells. This suppression is shared by a superantigenic-deficient mutant of TSST-1 but not by staphylococcal enterotoxins, suggesting that autophagic suppression of TSST-1 is superantigenic-independent. Furthermore, we showed that TSST-1-producing S. aureus suppresses autophagy in the response of infected cells. Our data provides a novel function of TSST-1 in autophagic suppression which may contribute in staphylococcal persistence in host cells.

ToxinsQ2 · MEDICINE

High Titer Persistent Neutralizing Antibodies Induced by TSST-1 Variant Vaccine Against Toxic Shock Cytokine Storm

Q2 · MEDICINE

ArticleOA

Author: Model, Nina ; Schwameis, Michael ; Eibl, Martha M. ; Firbas, Christa ; Jilma, Bernd ; Stich, Norbert ; Roetzer, Andreas

Staphylococcal superantigen toxins lead to a devastating cytokine storm resulting in shock and multi-organ failure. We have previously assessed the safety and immunogenicity of a recombinant toxic shock syndrome toxin 1 variant vaccine (rTSST-1v) in clinical trials (NCT02971670 and NCT02340338). The current study assessed neutralizing antibody titers after repeated vaccination with escalating doses of rTSST-1v. At study entry, 23 out of 34 subjects (67.6%) had neutralizing antibody titers inhibiting T cell activation as determined by 3H-thymidine incorporation at a serum dilution of ≤1:100 with similar figures for inhibition of IL-2 activation (19 of 34 subjects, 55.9%) as assessed by quantitative PCR. After the first vaccination, numbers of subjects with neutralization titers inhibiting T cell activation (61.7% ≥ 1:1000) and inhibiting IL-2 gene induction (88.2% ≥ 1:1000) increased. The immune response was augmented after the second vaccination (inhibiting T cell activation: 78.8% ≥ 1:1000; inhibiting IL-2 induction: 93.9% ≥ 1:1000) corroborated with a third immunization months later in a small subgroup of subjects. Assessment of IFNγ, TNFα and IL-6 inhibition revealed similar results, whereas neutralization titers did not change in placebo participants. Antibody titer studies show that vaccination with rTSST-1v in subjects with no/low neutralizing antibodies can rapidly induce high titer neutralizing antibodies persisting over months.

100 Deals associated with Recombinant toxic shock syndrome toxin-1 variant vaccine (Biomedizinische Forschungsgesellschaft)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Bacterial Infections	Phase 2	AT	Biomedizinische Forschungsgesellschaft mbH	28 Mar 2016

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Recombinant toxic shock syndrome toxin-1 variant vaccine (Biomedizinische Forschungsgesellschaft)

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