PIKA Rabies Vaccine Clinical Trails, Dosage, Indication, News, Side Effects
YS Biopharma Co., Ltd.'s PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried, utilizes YS Biopharma's proprietary PIKA adjuvant technology and is designed to produce a more robust immune response in an accelerated timespan compared to currently approved rabies vaccines. PIKA technology originated from research in a class of well-defined dsRNA molecules synthesized using our proprietary technology. In 2017, the U.S. Food and Drug Administration (FDA) granted the PIKA Rabies Vaccine Orphan Drug Designation to prevent rabies virus infection, including post-exposure prophylaxis (PEP) for rabies. This vaccine development project was named a "National Key Medicine Innovation" in 2013.
On April 9, 2024, the Company announced interim results indicating that the PIKA Rabies Vaccine has successfully met the primary endpoints of the Phase 3 Clinical Trial and has the potential to achieve best-in-class accelerated protection and meet the World Health Organization (WHO) goal of a one-week rabies vaccine regimen to replace the conventional three- or four-week regimens. The data, which comes from the first 900 participants enrolled in the Trial, revealed that the RVNA seroconversion rate of the PIKA Rabies Vaccine was twice that of the comparator by Day 7, showing the superiority of PIKA rabies vaccine to offer quick onset of protection against virus infection. This accelerated, and higher seroconversion rate came at no cost to safety, with the safety profile of the PIKA Rabies Vaccine remaining highly tolerable.
YS Biopharma Co., Ltd. is a global biopharmaceutical company located in Gaithersburg, MD., dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer.
PIKA Rabies Vaccine Clinical Trials
The Phase 3 Clinical Trial (NCT05667974) is a randomized, comparator-controlled, double-masked, multicenter trial with 4,500 participants from the Philippines and Pakistan. It is designed to assess the immunogenicity, safety, and lot-to-lot consistency of three lots of the PIKA Rabies Vaccine in healthy adults using a 7-day vaccine schedule versus a globally marketed comparator following the standard 28-day regimen. The primary immunogenicity endpoints of the study were geometric mean titers (GMTs) of rabies virus neutralizing antibodies (RVNA) and RVNA seroconversion rate at Day 14 in the first 900 participants. The secondary immunogenicity endpoints were RVNA seroconversion rate and GMTs of RVNA at Day 28, Day 42, Day 90, and Day 180 in the first 900 participants and RVNA seroconversion rate at Day 7 and Day 365 in all participants. Last Update Posted on January 24, 2024.
PIKA Rabies Vaccine News
April 9, 2024 - Dr. Zenaida Mojares, Chief Medical Officer of YS Biopharma, commented, "The interim results of the pivotal Phase 3 Trial provide compelling evidence of the robust immunogenicity and favorable safety profile of the PIKA Rabies. The PIKA Rabies Vaccine can potentially improve rabies treatment and compliance by providing a shortened treatment regimen without sacrificing safety or compliance. At present, the long and inconvenient regimen length for existing rabies vaccines represents a major barrier to treatment completion, and we are eager to see how the enhanced speed of the PIKA Rabies Vaccipositively impacts patients. We are proud of our team for the hard work and dedication that got us to this point, and we are excited to see how our advances will contribute to the ongoing global fight against rabies."
June 1, 2023 - YS Biopharma Co., Ltd. announced that its novel PIKA Rabies Vaccine was granted Phase 3 clinical trial approval from the Food and Drug Administration of the Philippines.
January 4, 2017 - Yisheng Biopharma announced that the U.S. FDA granted orphan drug designation for its lead vaccine candidate, PIKA rabies vaccine.
