A Paper on Phase II Clinical Trial Results of Innovative Therapeutic Hepatitis B Vaccine (Mimogen-based) (ɛPA-44 or Ipa in Chinese) developed by the team led by Prof. Wu Yuzhang from the Army Medical University was published on August 15 in Hepatology (https:doi.org/10.1002/hep.32109), the best journal on liver disease. This study was completed by 15 top clinical sites in China, including the Peking University People's Hospital. The corresponding author of the Paper was Prof. Wu Yuzhang from the Army Medical University, and the first authors were Prof. Wei Lai from Peking University People's Hospital, Prof. Zhao Tingting, Medical Director of Novel Peptide Bioscience Co., Ltd. and Dr. Zhang Ji from the Army Medical University. Based on Phase II clinical trial results, National Medical Products Administration gave the approval for Phase III Clinical Trial of Ipa, marking the start of the multi-center Phase III clinical trial of Project NHT210118 (ChiCTR2100043708).

The Phase II clinical trial of Project NHT210118 was a randomized, double-blind, multicenter, placebo-controlled trial in a large sample size up to 360 subjects, which was jointly completed by 15 clinical sites in China, including the Peking University People's Hospital. The trial results showed that the seroconversion rate of e antigens (HBeAg/HBsAb) in patients with chronic hepatitis B subcutaneously injected with 6 injections of 900 μg of Ipa was significantly improved, reaching 38.8% at Week 76 and 44% at Week 144 in the follow-up without rebound of the parameters after drug discontinuation, showing significantly better efficacy than that of the placebo (blank liposome) group (20.2%) and much better than that of the current interferon and antiviral drug therapy.

Following the online publication of the Paper on Phase II Clinical Trial Results of Project NHT210118 in Hepatology, Science and Technology Daily and Chongqing International Institute for Immunology also released such report.

Prophylactic vaccines, as traditional immunological techniques, have controlled and eliminated some serious infectious diseases, changed the human disease spectrum, and extended the average life span of human beings. However, therapeutic vaccines are considered as technologies with much-needed breakthroughs in the international community, and the Ipa design strategy provides important insights into the development of therapeutic vaccines for other chronic infectious diseases and tumors.