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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1 | Experimental |
| |
| Experimental 2 | Experimental |
| |
| Positive Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd) | Biological | Essen post-exposure immunization schedule at day 0,3,7,14,28. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate immunogenicity after the first dose | Percentage of participants with rabies virus neutralizing antibody concentration ≥0.5 IU/ml. | 14 days following the first dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days following the last dost |
| GMC of rabies virus neutralizing antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuemei Hu, Master | Jiangsu Provincial Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu | 210009 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40188565 | Derived | 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. |
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| Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd) | Biological | Zagreb post-exposure immunization schedule at day 0,7,21. |
|
| Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.) | Biological | Essen post-exposure immunization schedule at day 0,3,7,14,28. |
|
| 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 | from day 0 to day 28 post the last dose |
| Proportion of subjects with Serious Adverse Events occurring throughout the trial | Day 0 up to month 12 |
| ID | Term |
|---|---|
| D011819 | Rabies Vaccines |
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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