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001-es BibID:	BIBFORM101129
035-os BibID:	(cikkazonosító)340 (WoS)000762112800001 (Scopus)85125243628
Első szerző:	Girardi Petra
Cím:	Evaluation of the Safety, Tolerability and Immunogenicity of ShigETEC, an Oral Live Attenuated Shigella-ETEC Vaccine in Placebo-Controlled Randomized Phase 1 Trial / Petra Girardi, Shushan Harutyunyan, Irene Neuhauser, Katharina Glaninger, Orsolya Korda, Gábor Nagy, Eszter Nagy, Valéria Szijártó, Denes Pall, Krisztina Szarka, Gábor Kardos, Tamás Henics, Frank J. Malinoski
Dátum:	2022
ISSN:	2076-393X
Megjegyzések:	Shigella spp. and enterotoxigenic Escherichia coli (ETEC) cause high morbidity and mortality worldwide, yet no licensed vaccines are available to prevent corresponding infections. A live attenuated non-invasive Shigella vaccine strain lacking LPS O-antigen and expressing the ETEC toxoids, named ShigETEC was characterized previously in non-clinical studies. Methods: ShigETEC was evaluated in a two-staged, randomized, double-blind and placebo-controlled Phase I clinical trial. A single dose of increasing amounts of the vaccine was given to determine the maximum tolerated dose and increasing number of immunizations were administered with an interval based on the duration of shedding observed. Results: Oral immunization with ShigETEC was well tolerated and safe up to 4-time dosing with 5 ? 1010 colony forming units. ShigETEC induced robust systemic immune responses against the Shigella vaccine strain, with IgA serum antibody dominance, as well as mucosal antibody responses evidenced by specific IgA in stool samples and in ALS (Antibodies in Lymphocyte Supernatant). Anti- ETEC toxin responses were detected primarily in the 4-times immunized cohort and for the heat-labile toxin correlated with neutralizing capacity. Conclusion: ShigETEC is a promising vaccine candidate that is scheduled for further testing in controlled human challenge studies for efficacy as well as in children in endemic setting for safety and immunogenicity.
Tárgyszavak:	Orvostudományok Gyógyszerészeti tudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk Shigella enterotoxigenic E. coli vaccine oral Phase 1 clinical study ETEC toxins
Megjelenés:	Vaccines. - 10 : 2 (2022), p. 1-15. -
További szerzők:	Harutyunyan, Shushan Neuhauser, Irene Glaninger, Katharina Korda Orsolya Nagy Gábor Nagy Eszter (Arsanis Inc. Vienna, Austria) Szíjártó Valéria Páll Dénes (1967-) (belgyógyász, kardiológus) Szarka Krisztina (1971-) (molekuláris biológus, mikrobiológus) Kardos Gábor (1974-) (szakorvos, klinikai mikrobiológus) Henics Tamás Malinoski, Frank J.
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