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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,800
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.
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
To evaluate immunogenicity after the first dose
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml.
Time frame: 14 days following the first dose
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml after the last dose.
Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml after the last dose.
Time frame: 14 days following the last dost
GMC of rabies virus neutralizing antibody
Time frame: day 7 and 14 post the first dose and day 14 post the last dose
Proportion of subjects reporting of adverse reaction and unsolicited adverse events
Time frame: from day 0 to day 28 post the last dose
Proportion of subjects with Serious Adverse Events occurring throughout the trial
Time frame: Day 0 up to month 12
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