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The kickoff meeting for the Phase I clinical trial of freeze-dried human rabies vaccine (human diploid cells) was successfully held

Time of issue:2023-11-27
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[概述]Recently, the phase I clinical trial kickoff meeting of Ab&B Bio Tech CO., LTD. JS freeze-dried human rabies vaccine (human diploid cells) was successfully held at the research site in Hubei.

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The kickoff meeting for the Phase I clinical trial of freeze-dried human rabies vaccine (human diploid cells) was successfully held

[概述]Recently, the phase I clinical trial kickoff meeting of Ab&B Bio Tech CO., LTD. JS freeze-dried human rabies vaccine (human diploid cells) was successfully held at the research site in Hubei.

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Time of issue:2023-11-27
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Recently, the phase I clinical trial kickoff meeting of Ab&B Bio Tech CO., LTD. JS freeze-dried human rabies vaccine (human diploid cells) was successfully held at the research site in Hubei.

This clinical trial is a phase I randomized, single arm trial designed to evaluate the safety of freeze-dried human rabies vaccine (human diploid cells) administered to a population aged 10-60 using three different immunization programs: five needle method, 2+1+1, and simple four needle method.

Rabies is a serious natural zoonotic infectious disease. Approximately 59000 people worldwide die from rabies each year, with 99% of deaths occurring in Africa and Asia, resulting in estimated economic losses of $8.6 billion per year. China is one of the countries with severe outbreaks of rabies, with approximately 40 million people being bitten by animals each year. Vaccination against rabies is an important means of preventing rabies.

In the 1880s, Louis Pasteur invented the first generation of neural tissue vaccines, which were gradually phased out due to their high incidence of adverse reactions after vaccination, multiple doses of full immunization, and poor immune response protection. After the 1950s, avian embryo culture vaccines were developed, but compared to the previous generation, the adverse reaction rate was still relatively high, the immune protection effect was not ideal, and there was no superiority, which was not promoted. The human diploid cell vaccine, pioneered by the Wistar Research Institute in 1967, has high antibody titers, low incidence of adverse reactions, and high safety after vaccination with the WI-38 cell line. It has been recommended by the WHO as the gold standard for human rabies vaccines.

The human diploid cell rabies vaccine (HDCV) has been used in Europe and North America for over 40 years and has been proven to be safe and efficient. It is commonly used as a standard control vaccine for newly developed rabies vaccines. The overall incidence of adverse reactions in HDCV is significantly lower than that of purified chicken embryo cell vaccine (PCECV). Compared with purified Vero cell vaccines (PVRV), HDCV has a lower incidence of local pain, fever, and weakness. The incidence of local pain and fever caused by HDCV is lower than that of PCECV. Compared with the other two rabies vaccines, HDCV has shown advantages in terms of safety. HDCV has been observed to exhibit better immunogenicity on a large scale in the United States, Thailand, India, Iran, and other countries.

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Pre: Ab&B Bio Tech CO., LTD. JS invited to attend the China Ukraine Trade Cooperation Seminar

Next: Successfully selected as a national open topic!

Pre: Ab&B Bio Tech CO., LTD. JS invited to attend the China Ukraine Trade Cooperation Seminar

Next: Successfully selected as a national open topic!

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The kickoff meeting for the Phase I clinical trial of freeze-dried human rabies vaccine (human diploid cells) was successfully held

The kickoff meeting for the Phase I clinical trial of freeze-dried human rabies vaccine (human diploid cells) was successfully held