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Kickoff Meeting for Phase I Clinical Trial of Freeze-Dried Human Rabies Vaccine (Human Diploid Cells) Successfully Held
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- Time of issue:2023-11-27
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(Summary description)Recently, the Phase I clinical trial kickoff meeting for Ab&B Bio Tech Co., Ltd. JS's freeze-dried human rabies vaccine (human diploid cells) was successfully held at the research site in Hubei Province. This cli
Kickoff Meeting for Phase I Clinical Trial of Freeze-Dried Human Rabies Vaccine (Human Diploid Cells) Successfully Held
(Summary description)Recently, the Phase I clinical trial kickoff meeting for Ab&B Bio Tech Co., Ltd. JS's freeze-dried human rabies vaccine (human diploid cells) was successfully held at the research site in Hubei Province.
This cli
- Categories:Company news
- Author:
- Origin:
- Time of issue:2023-11-27 15:19
- Views:
Recently, the Phase I clinical trial kickoff meeting for Ab&B Bio Tech Co., Ltd. JS's freeze-dried human rabies vaccine (human diploid cells) was successfully held at the research site in Hubei Province.
This clinical trial is a Phase I, randomized, single-arm study designed to evaluate the safety of the freeze-dried human rabies vaccine (human diploid cells) in participants aged 10–60 years using three immunization schedules: the five-dose Essen regimen, the 2-1-1 Zagreb regimen, and the simplified four-dose regimen.
Rabies is a severe zoonotic infectious disease. Approximately 59,000 people worldwide die from rabies each year, with 99% of cases occurring in Africa and Asia, resulting in estimated economic losses of $8.6 billion annually. China is one of the countries most affected by rabies, with approximately 40 million people exposed to animal bites each year. Vaccination remains the most effective means of rabies prevention.
In the 1880s, Louis Pasteur developed the first-generation neural tissue vaccine, which was gradually phased out due to its high rate of adverse reactions, multiple-dose immunization requirements, and suboptimal immune protection. After the 1950s, avian embryo culture vaccines were introduced, but they still exhibited relatively high adverse reaction rates and inferior immunogenicity, limiting their widespread adoption.
In 1967, the Wistar Institute pioneered the human diploid cell vaccine (HDCV) using the WI-38 cell line, which demonstrated high antibody titers, low adverse reaction rates, and excellent safety. The World Health Organization (WHO) subsequently recommended HDCV as the gold standard for human rabies vaccines.
HDCV has been used in Europe and North America for over 40 years, proving its safety and efficacy. It is commonly used as a reference vaccine in clinical trials for new rabies vaccines. The overall adverse reaction rate of HDCV is significantly lower than that of purified chick embryo cell vaccine (PCECV). Compared with purified Vero cell rabies vaccine (PVRV), HDCV shows lower rates of local pain, fever, and fatigue. Additionally, HDCV causes less local pain and fever than PCECV, demonstrating superior safety over both alternatives.
Large-scale studies in the United States, Thailand, India, Iran, and other countries have confirmed HDCV's strong immunogenicity.
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