Immunogenicity and Safety of A Lyophilized Purified Human Diploid Cell Rabies Vaccine .
Condition: Adverse Effect and Immunogenicity of Vaccine
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd); Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd); Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Essen post-exposure immunization schedule at day 0,3,7,14,28.; Zagreb post-exposure immunization schedule at day 0,7,21.; Essen post-exposure immunization schedule at day 0,3,7,14,28.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention