A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 results.
Staphylococcus aureus
Superantigen
TSST-1
Toxic shock syndrome
Vaccine
Journal
EClinicalMedicine
ISSN: 2589-5370
Titre abrégé: EClinicalMedicine
Pays: England
ID NLM: 101733727
Informations de publication
Date de publication:
Jan 2024
Jan 2024
Historique:
received:
31
10
2023
revised:
14
12
2023
accepted:
14
12
2023
medline:
26
1
2024
pubmed:
26
1
2024
entrez:
26
1
2024
Statut:
epublish
Résumé
Toxic shock syndrome toxin-1 (TSST-1) is a superantigen produced by 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) 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. 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. Biomedizinische Forschung & Bio-Produkte AG funded this study.
Sections du résumé
Background
UNASSIGNED
Toxic shock syndrome toxin-1 (TSST-1) is a superantigen produced by
Methods
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
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
UNASSIGNED
Biomedizinische Forschung & Bio-Produkte AG funded this study.
Identifiants
pubmed: 38274114
doi: 10.1016/j.eclinm.2023.102404
pii: S2589-5370(23)00581-3
pmc: PMC10808908
doi:
Banques de données
ClinicalTrials.gov
['NCT02814708']
Types de publication
Journal Article
Langues
eng
Pagination
102404Informations de copyright
© 2024 Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
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.