Intranasal therapeutic vaccine containing HBsAg and HBcAg for patients with chronic hepatitis B; 18 months follow‐up results of phase IIa clinical study
| العنوان: | Intranasal therapeutic vaccine containing HBsAg and HBcAg for patients with chronic hepatitis B; 18 months follow‐up results of phase IIa clinical study |
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| المؤلفون: | Osamu Yoshida, Sheikh Mohammad Fazle Akbar, Yusuke Imai, Takahiro Sanada, Kyoko Tsukiyama‐Kohara, Takashi Miyazaki, Taizou Kamishita, Teruki Miyake, Yoshio Tokumoto, Hayato Hikita, Masataka Tsuge, Masahito Shimizu, Mamun Al Mahtab, Julio Cesar Aguilar, Gerardo Guillen, Michinori Kohara, Yoichi Hiasa |
| المصدر: | Hepatology Research. 53:196-207 |
| بيانات النشر: | Wiley, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Infectious Diseases, Hepatology |
| الوصف: | HBsAg loss with anti-HBs acquisition is considered a functional cure and ideal treatment goal for patients with CHB. Our group have reported the efficacy of therapeutic vaccine with HBsAg and HBcAg (NASVAC) by intranasal and subcutaneous injection. In this study, we investigated the safety and efficacy of newly developed CVP-NASVAC, which contained NASVAC with mucoadhesive carboxyl vinyl polymer (CVP) in the dedicated device.A single dose, open-label, phase IIa clinical trial of CVP-NASVAC was conducted. Patients with CHB treated with nucleoside/nucleotide analogs (NAs) and HBV carriers not undergoing anti-HBV treatment were enrolled. CVP-NASVAC was injected through the nose for, in total, 10 times. Participants were followed-up for 18 months, and their HBsAg reduction and anti-HBs induction assessed as endpoints.Among the patients with CHB treated with NAs (n = 27) and HBV carriers without NAs (n = 36), 74.1% and 75.0% exhibited reductions in their baseline HBsAg, and the mean reductions were -0.1454 logAnti-HBs induction and HBsAg reduction was observed after CVP-NASVAC treatment in some patients with CHB. The CVP-NASVAC is a safe treatment, which might expect to achieve functional cure for patients with CHB. |
| تدمد: | 1872-034X 1386-6346 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4585b2221a2b92dcfd7a3959b81669bb https://doi.org/10.1111/hepr.13851 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....4585b2221a2b92dcfd7a3959b81669bb |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1872034X 13866346 |
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