Bibliographic Details
| Title: |
A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 resultsResearch in context |
| Authors: |
Christian Schoergenhofer, Georg Gelbenegger, Dzenita Hasanacevic, Léa Schöner, Margarete M. Steiner, Christa Firbas, Nina Buchtele, Ulla Derhaschnig, Andreas Tanzmann, Nina Model, Julian Larcher-Senn, Manuel Drost, Martha M. Eibl, Andreas Roetzer, Bernd Jilma |
| Source: |
EClinicalMedicine, Vol 67, Iss , Pp 102404- (2024) |
| Publisher Information: |
Elsevier, 2024. |
| Publication Year: |
2024 |
| Collection: |
LCC:Medicine (General) |
| Subject Terms: |
Staphylococcus aureus, Toxic shock syndrome, Superantigen, TSST-1, Vaccine, Medicine (General), R5-920 |
| More Details: |
Summary: Background: Toxic shock syndrome toxin-1 (TSST-1) is a superantigen produced by Staphylococcus aureus that causes the life-threatening toxic shock syndrome. The development of a safe and immunogenic vaccine against TSST-1 remains an unmet medical need. We investigated the safety, tolerability and immunogenicity of a recombinant TSST-1 variant vaccine (rTSST-1v) after 1–3 injections in healthy volunteers. 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)3. The primary endpoint was safety and tolerability of rTSST-1v in the intention-to-treat population. The per-protocol population was used for the immunogenicity analysis. The trial is registered with EudraCT#: 2015-003714-24; ClinicalTrials.gov#: NCT02814708. 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. |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
2589-5370 |
| Relation: |
http://www.sciencedirect.com/science/article/pii/S2589537023005813; https://doaj.org/toc/2589-5370 |
| DOI: |
10.1016/j.eclinm.2023.102404 |
| Access URL: |
https://doaj.org/article/c5ad4265a94d4108997a1f30384cf6b2 |
| Accession Number: |
edsdoj.5ad4265a94d4108997a1f30384cf6b2 |
| Database: |
Directory of Open Access Journals |
