Safety and immunogenicity of the therapeutic vaccine TG1050 in chronic hepatitis B patients: a phase 1b placebo-controlled trial.

Human Vaccines & Immunotherapeutics
Fabien ZoulimGenevieve Inchauspe

Abstract

Treatment of chronic hepatitis B (CHB) typically requires life-long administration of drugs. Cohort and pre-clinical studies have established the link between a functional T-cell-mounted immunity and resolution of infection. TG1050 is an adenovirus 5-based vaccine that expresses HBV polymerase and domains of core and surface antigen and has shown immunogenicity and antiviral effects in mice. We performed a phase 1 clinical trial to assess safety and explore immunogenicity and early efficacy of TG1050 in CHB patients. This randomized, double blind, placebo-controlled study included two sequential phases: one single dose cohort (SD, n = 12) and one multiple (3) doses cohort (MD, n = 36). Patients, virally suppressed under nucleoside(d)tide analog NUC therapy, were randomized 1:1:1 across 3 dose levels (DL) and assigned to receive 109, 1010, 1011 virus particles (vp) of TG1050 and then randomized within each DL to placebo (3:1 and 9:3 vaccines/placebo in each DL, respectively, for the SD and MD cohorts). Cellular (ELISPOT) and antibody responses (anti-Adenovirus), as well as evolution of circulating HBsAg and HBcrAg, were monitored. All doses were well tolerated in both cohorts, without severe adverse event. TG1050 was capable to ...Continue Reading

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Citations

Mar 21, 2020·Frontiers in Immunology·Ruben C Hoogeveen, André Boonstra
Oct 7, 2020·Journal of Clinical Medicine·Alexandra AlexopoulouPeter Karayiannis
May 11, 2021·Clinical and Experimental Immunology·Tamsin Cargill, Eleanor Barnes
Jun 23, 2021·Liver International : Official Journal of the International Association for the Study of the Liver·Armando Andres Roca SuarezFabien Zoulim
Jun 18, 2021·World Journal of Gastroenterology : WJG·Efthymios P TsounisChristos Triantos

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Methods Mentioned

BETA
FCS
PCR
ELISA

Clinical Trials Mentioned

NCT02428400

Software Mentioned

SAS®

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