A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 results.
| Autor: | Schoergenhofer C; Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria., Gelbenegger G; Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria., Hasanacevic D; Biomedizinische Forschung & Bio-Produkte AG, Vienna, Austria., Schöner L; Biomedizinische Forschung & Bio-Produkte AG, Vienna, Austria., Steiner MM; Division of General Anesthesia and Intensive Care Medicine, Department of Anesthesia, Critical Care and Pain Medicine, Medical University of Vienna, Vienna, Austria., Firbas C; Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria., Buchtele N; Division of Medicine I, Intensive Care Unit 13i2, Medical University of Vienna, Vienna, Austria., Derhaschnig U; Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria., Tanzmann A; Department of Blood Group Serology and Transfusion Medicine, Medical University of Vienna, Vienna, Austria., Model N; Biomedizinische Forschung & Bio-Produkte AG, Vienna, Austria., Larcher-Senn J; Assign Data Management and Biostatistics GmbH, Innsbruck, Austria., Drost M; Assign Data Management and Biostatistics GmbH, Innsbruck, Austria., Eibl MM; Biomedizinische Forschung & Bio-Produkte AG, Vienna, Austria., Roetzer A; Biomedizinische Forschung & Bio-Produkte AG, Vienna, Austria., Jilma B; Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria. |
|---|---|
| Jazyk: | angličtina |
| Zdroj: | EClinicalMedicine [EClinicalMedicine] 2024 Jan 05; Vol. 67, pp. 102404. Date of Electronic Publication: 2024 Jan 05 (Print Publication: 2024). |
| DOI: | 10.1016/j.eclinm.2023.102404 |
| Abstrakt: | 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) 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. Competing Interests: GG, CS, CF, MMS, NB, UD, AT, and BJ declare no competing interests. Martha M. Eibl was the owner of Biomedizinische Forschung & Bio-Produkte AG. DH, LS, NM, and AR are employees of the study funder Biomedizinische Forschung & Bio-Produkte AG, a biotechnology company engaged in the development of BioMed rTSST-1v. (© 2024 Published by Elsevier Ltd.) |
| Databáze: | MEDLINE |
| Externí odkaz: |
|