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PubMed · 42623526

A randomized trial of viral vector and adjuvanted protein HBV therapeutic vaccine in people with chronic hepatitis B on nucleos(t)ide analogs.

Wen-Juei Jeng·Chi-Jen Chu·Apinya Leerapun·Anchalee Avihingsanon·Stefan Zeuzem·Stefan Bourgeois·Man-Fung Yuen·Manuel Romero-Gomez·Sheng-Shun Yang·Cristina Cravcenco·Bruno Salaun·Meng Shi·Ventzislav Vassilev·Joon Hyung Kim·Kristien Swinnen·and the TH HBV VV-001 Study Group
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Abstract

BACKGROUND: This study assessed the safety, efficacy, and immunogenicity of a therapeutic immunization strategy aimed at reaching a functional cure for chronic hepatitis B (CHB), relying on a heterologous prime-boost with viral vectors ChAd155-hIi-HBV and MVA-HBV, combined with sequential or concomitant administration of adjuvanted recombinant HBV proteins (HBc-HBs/AS01B). METHODS: This single-blind, randomized, controlled, first-in-human, phase 1/2 trial enrolled adults aged 18-65 years with HBeAg-negative CHB, virally suppressed on nucleos(t)ide analogs (NAs), with HBsAg >50 IU/mL. Participants received NAs and the following regimens of 4 doses (8-week intervals): sequential administration of ChAd155-hIi-HBV, MVA-HBV, and 2 HBc-HBs/AS01B doses; co-administration of ChAd155-hIi-HBV+HBc-HBs/AS01B, followed by 3 co-administered MVA-HBV+HBc-HBs/AS01B doses; 4 HBc-HBs/AS01B doses; 2 placebo doses followed by ChAd155-hIi-HBV and MVA-HBV administered alone or with HBc-HBs/AS01B; or 4 placebo doses. Safety, efficacy (≥1-log decrease in quantitative (q)HBsAg or HBsAg loss 24 weeks post-dose 4 [day (D)337]), antibody, and T-cell responses were evaluated. RESULTS: In all, 134 participants were vaccinated. Grade 3 solicited adverse events (AEs) (median duration: 2-3 days) were more frequent after co-administration (systemic: 59.3%; administration-site: 33.3%) than sequential administration (systemic: 10.3%; administration-site: 12.8%) of high-dose viral vectors and proteins. No vaccine-related or fatal serious AEs were reported. After 4 doses, no participant had HBsAg loss or ≥1-log decrease in qHBsAg (D337 vs. D1). Co-administration induced the strongest anti-HBs response (73.7% achieved anti-HBs ≥10 mIU/mL 2 weeks post-dose 4 vs. 40.0% after sequential administration). Both sequential and co-administration induced HBc-specific CD4+ and CD8+ T-cell responses, with a prime-boost effect of the viral vectors. CONCLUSIONS: Heterologous prime-boost with ChAd155-hIi-HBV and MVA-HBV, combined with sequential or co-administration of HBc-HBs/AS01B, had an acceptable safety profile, were moderately immunogenic, but no participants showed the expected efficacy outcome.

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HumansAdultFemaleMiddle AgedMaleHepatitis B, ChronicHepatitis B VaccinesSingle-Blind MethodYoung AdultAdjuvants, ImmunologicAdolescentGenetic VectorsAntiviral AgentsHepatitis B Surface AntigensHepatitis B virusAgedHepatitis B AntibodiesTreatment Outcomefunctional cure“Hepatitis B Core Antigens”“Hepatitis B Surface Antigens”“Immunity, Cellular”“Immunity, Humoral”“Immunotherapy”Journal ArticleRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase I

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Wen-Juei Jeng, Chi-Jen Chu, Apinya Leerapun, Anchalee Avihingsanon, Stefan Zeuzem, Stefan Bourgeois, Man-Fung Yuen, Manuel Romero-Gomez, Sheng-Shun Yang, Cristina Cravcenco, Bruno Salaun, Meng Shi, Ventzislav Vassilev, Joon Hyung Kim, Kristien Swinnen, and the TH HBV VV-001 Study Group. 2026-08-20. A randomized trial of viral vector and adjuvanted protein HBV therapeutic vaccine in people with chronic hepatitis B on nucleos(t)ide analogs.. https://doi.org/10.1097/hc9.0000000000001025

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Adolescent subjectAdult subjectAged subjectClinical Trial, Phase I subjectClinical Trial, Phase II subjectFemale subjectHepatitis B Antibodies subjectHepatitis B Surface Antigens subjectHepatitis B Vaccines subjectHumans subjectJournal Article subjectJournal Article; Randomized Controlled Trial; Clinical Trial, Phase II; Clinical Trial, Phase I resourceMale subjectMiddle Aged subjectRandomized controlled trials study

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