A randomized trial of viral vector and adjuvanted protein HBV therapeutic vaccine in people with chronic hepatitis B on nucleos(t)ide analogs
Rattachement africain : tw, th, de, be, cn, hk, es, us. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
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.
Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.
Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- A randomized trial of viral vector and adjuvanted protein HBV therapeutic vaccine in people with chronic hepatitis B on nucleos(t)ide analogs
- Date Crossref
- 20/08/2026
- Éditeur
- Ovid Technologies (Wolters Kluwer Health)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
-
Chang Gung University pays non établi dans la noticeUniversité ou école supérieure
-
Linkou Chang Gung Memorial Hospital Department of Gastroenterology and Hepatology pays non établi dans la noticeÉtablissement de santé
-
National Yang Ming Chiao Tung University pays non établi dans la noticeUniversité ou école supérieure
-
Taipei Veterans General Hospital Department of Medicine pays non établi dans la noticeÉtablissement de santé
-
Chiang Mai University pays non établi dans la noticeUniversité ou école supérieure
-
HIV Netherlands Australia Thailand Research Collaboration pays non établi dans la noticeStructure de recherche
-
Goethe University Frankfurt pays non établi dans la noticeUniversité ou école supérieure
-
University Hospital Frankfurt Department of Medicine pays non établi dans la noticeÉtablissement de santé
-
Province of Antwerp pays non établi dans la noticeOrganisme public
-
Queen Mary Hospital pays non établi dans la noticeÉtablissement de santé
-
University of Hong Kong Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
-
Instituto de Biomedicina de Sevilla pays non établi dans la noticeStructure de recherche
Chang Gung University, Department of Gastroenterology and Hepatology — Linkou Chang Gung Memorial Hospital et National Yang Ming Chiao Tung University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.