NCT03971370

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

Immunogenicity and Safety of A Lyophilized Purified Human Diploid Cell Rabies Vaccine in Chinese Healthy People Aged 10-60 Years.: A Randomized, Blinded, Phase III Clinical Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 10 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Rabies is caused by rabies virus with a 100% mortality rate in humans. An estimated 59000 human deaths and over 3.7 million disability-adjusted life years lost every year. Most of cases occur in Africa and Asia, mainly in underserved populations, with approximately 40% of cases in children aged \<15 years. WHO and its partners have endorsed a target of Zero Human Rabies Deaths from dog-transmitted rabies by 2030 (Zero by 30). Fortunately, rabies is a vaccine-preventable disease in both humansand animals. At present, chicken embryo cell vaccine, Vero cell vaccine, hamster kidney cell vaccine, and human diploid cell (HDC) rabies vaccine (HDCV) have been approved. The WHO clearly states that HDCV is the "gold standard" rabies vaccine. Because HDCs are normal karyotype cells without carcinogenicity, the HDCV does not contain any foreign animal impurity or neurotoxicity factor. Furthermore, there are fewer injections required and mild adverse reactions and it is safe and efficacious; thus, it is recommended by the WHO as the "nearly ideal human vaccine." Although HDCV was primarily used in developed countries prior to 2015, China does not approve the import of foreign HDCV. Meanwhile, domestic diploid rabies vaccine for human use is insufficiency and in this regard, Minhai Biothechnology Co., Ltd in China has overcome technical difficulties for the large-scale developing of a lyophilized and purified HDCV. This clinic trial was to assess the immunogenicity and safety of HDCV in healthy population vaccinated according to the Essen and Zagreb post-exposure immunization schedule, exploring the appropriate immunization procedures.

Conditions

• Adverse Effect and Immunogenicity of Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)	Essen post-exposure immunization schedule at day 0,3,7,14,28.
BIOLOGICAL	Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)	Zagreb post-exposure immunization schedule at day 0,7,21.
BIOLOGICAL	Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.)	Essen post-exposure immunization schedule at day 0,3,7,14,28.

Timeline

• Start date: 2017-09-10
• Primary completion: 2018-09-29
• Completion: 2019-02-22
• First posted: 2019-06-03
• Last updated: 2019-06-03

Locations

1 site across 1 country: China