LakeShore Biopharma Co., Ltd has received approval from China's National Medical Products Administration (NMPA) to begin a Phase III clinical trial evaluating simplified four-dose regimens of its YSJA rabies vaccine. The trial, expected to commence in December 2024, will assess the immunogenicity and safety of the vaccine using two distinct four-dose schedules compared to the existing five-dose Essen regimen.
The study is designed as a single-center, randomized, double-blind, controlled trial. It will compare the Zagreb regimen (2-1-1), involving two doses in the first session followed by one dose in each of the next two sessions, and the Modified Essen regimen (1-1-1-1), consisting of a single dose across four sessions, against the conventional Essen regimen (1-1-1-1-1).
Rationale for Simplified Regimens
The primary goal of exploring these simplified immunization schedules is to offer greater flexibility for both healthcare providers and patients. A more convenient regimen could lead to improved patient adherence to the full course of vaccination, reduce the number of hospital visits required, and potentially lower the financial burden on patients. Ultimately, this could enhance the vaccine's utility and contribute to more effective rabies prevention efforts.
Management Perspective
"The approval of this Phase III clinical trial for our YSJA rabies vaccine marks a significant milestone in our efforts to expand the regimen profile of our product," said Mr. Xu Wang, Chief Executive Officer of LakeShore Biopharma. "By evaluating simplified immunization schedules, we aim to make our vaccine more competitive in the rapidly expanding rabies vaccine market. We believe that this trial will validate the clinical superiority of the YSJA rabies vaccine, and will help attract increased recognition and support from researchers, academics, and industry players around the world."
Impact of Rabies
Rabies remains a significant global health threat, with an almost 100% fatality rate once clinical symptoms manifest. The disease claims approximately 59,000 lives each year across more than 150 countries. Transmission primarily occurs through bites from infected animals, with dogs accounting for over 95% of human rabies fatalities. A disproportionate number of these deaths (40%) occur in children under the age of 15. Post-exposure prophylaxis, including vaccination, is highly effective in preventing rabies if administered promptly after exposure.
About YSJA Rabies Vaccine
The YSJA rabies vaccine is LakeShore Biopharma's flagship product, with over 100 million doses sold since its initial market approval. The company aims to solidify its position as a leading rabies vaccine supplier and innovator through this clinical trial and other ongoing development efforts.
