Immunogenicity and Safety of A Lyophilized Purified Human Diploid Cell Rabies Vaccine .

Summary

Rabies is caused by rabies virus with a 100% mortality rate in humans. Most of cases occur in Africa and Asia, mainly in underserved populations. Rabies is a vaccine-preventable disease in both humans and animals. The WHO clearly states that human diploid cell rabies vaccine is the "gold standard" rabies vaccine, because of no carcinogenicity and any foreign animal impurity or neurotoxicity factor. China does not approve the import of foreign HDCV and has insufficiency domestic HDCV, so this clinic trial was to assess the immunogenicity and safety of HDCV in healthy population for the large-scale developing of a lyophilized and purified HDCV.

Timeline

Start

2017-09-10

Primary completion

2018-09-29

Completion

2019-02-22

Publications

• Li G, Cao S, Xu B, Hu J, Zhang L, Shi L, Zhao D, Li Y, Liu Y, Liang Q, Wu X. Safety, immunogenicity and immune persistence of a lyophilized purified human diploid cells rabies vaccine following rabies PEP regimen Essen and Zagreb: A randomized, blinded controlled phase 3 trial in healthy participants aged 10-60 years old. Vaccine. 2025 Apr 19;53:127082. doi: 10.1016/j.vaccine.2025.127082. Epub 2025 Apr 5.

Drugs

Indications

No indication recorded.