Intranasal therapeutic vaccine containing HBsAg and HBcAg for patients with chronic hepatitis B; 18 months follow‐up results of phase IIa clinical study

Aims 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. Methods 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. Results 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 log10 IU/ml (p