DENDRITIC cells (DCs) are recognised as the most potent antigen-presenting cells in immune therapies for chronic hepatitis B (CHB). A clinical trial was conducted to evaluate the efficacy and safety of autologous HBV vaccine-pulsed dendritic cells and their induced T cells (HPDCT) in CHB patients. This randomised, prospective, open-label, multicentre study included 309 treatment-naïve CHB patients divided into four groups: HPDCT combined with nucleos(t)ide analogues (NAs) (n=84), NAs monotherapy (n=82), HPDCT combined with Peg-interferon (Peg-IFN) (n=69), and Peg-IFN monotherapy (n=74).
Participants received 12 intravenous HPDCT vaccinations over 72 weeks, during which 1,836 HPDCT infusions were administered. The therapy was well tolerated, with no significant toxicity or side effects, except for a few cases of mild, self-limiting fever. Patients receiving HPDCT therapy demonstrated higher rates of HBsAg loss, highlighting its potential efficacy.
Among patients treated with HPDCT combined with Peg-IFN, those with baseline HBV DNA levels below 1×10⁷ IU/mL experienced earlier, stronger, and longer-lasting viral responses compared to Peg-IFN monotherapy. This included a notable reduction in HBV DNA to below 20 IU/mL, observed from week 24 through week 72 (p<0.05). However, the efficacy of HPDCT combined with NAs was comparable to that of NAs monotherapy.
HPDCT combined with antiviral therapies significantly enhanced T cell immunity, as evidenced by increased levels of CD25 on CD8+ T cells and HBV-specific CD8+ T cells. This suggests an immune-stimulating effect that complements antiviral treatments.
In conclusion, HPDCT combined with antiviral drugs was found to be safe, effective, and capable of boosting T cell responses. When paired with Peg-IFN, it provided incremental benefits for patients with lower baseline HBV DNA levels, offering a promising therapeutic option for managing CHB.
Katie Wright, EMJ
Reference
Gu Y et al. Immunotherapy using HBV vaccine pulsed DCs and induced T-cells combined antiviral drugs in treatment naive CHB patients-a multi-centre Phase II study. J Viral Hepat. 2025;32(2):e14045.
