Monitoring of HBV-specific CD4 and CD8 T cells following therapeutic vaccination in a phase 1a clinical trial

Le résumé fourni par la source

Chronic hepatitis B (CHB) is the most common chronic viral infection, with more than 250 million people affected worldwide, resulting in 1 million deaths per year. CHB patients are characterised by a scarce and impaired antiviral T-cell response, prompting efforts to develop immunotherapies to restore protective T-cell immunity in the liver and achieve functional cure. TherVacB, a heterologous prime-boost vaccination scheme, has been shown to elicit a robust CD4 and CD8 T-cell response in preclinical models, resulting in infection resolution. Within the scope of a ‘first-in-human’-phase-1a clinical trial assessing the safety and efficacy of TherVacB in healthy volunteers, the following workflow allowed for the detailed analysis of the magnitude, phenotype, and functionality of the vaccine-induced de novo HBV-specific CD4 and CD8 T cells: Blood was sampled from healthy volunteers on day 0, 35, 70, and 224 following vaccination. After isolation of PBMCs, cells were re-stimulated with HBV surface, core and polymerase peptide pools, and subsequently analysed by multi-parameter spectral flow cytometry. HBV-specific CD4 and CD8 T cells were identified by the production of IL-2, IFNg, IL-4, IL-21, and the degranulation protein LAMP1 in response to peptide stimulation. The expression profile of these cytokine-positive T cells indicates their activation versus memory status and liver-residency or lymphoid tissue-associated phenotype. The characterisation of vaccine-induced HBV-specific CD4 and CD8 T cells in healthy volunteers will serve as a critical baseline from which to compare the response of chronic HepatitisB patients prior to and following therapeutic vaccination with TherVacB in an ongoing phase-1b/2a clinical study. Publication History Article published online: 26 January 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.