Inactivated Japanese Encephalitis Vaccine for Human Use (Vero cell) (IJEV)-Chengda biotechnology

中 / EN



中文 EN

Home page

Market-launched Products

Products in the Pipeline

Inactivated Japanese Encephalitis Vaccine for Human Use (Vero cell) (IJEV)

Classification:

Market-launched Products

Product Description

Inactivated Japanese Encephalitis Vaccine for Human Use (Vero cell) (IJEV)

IJEV, launched in 2008, will stimulate the body to generate immunity against Japanese encephalitis virus upon the vaccination, effectively preventing the epidemic of Japanese encephalitis. This product has been exported to Thailand, which is applicable to a broader range of populations, showing excellent immunogenicity, and offering the enhanced purity and safety.

Product Characteristics

1. Applicable to a Broader Population

IJEV, with no live virus, can eliminate the risk of virulence re-emergence, which avoids the vaccine-related cases and vaccine-derived virus. It is not only applicable to healthy children of the appropriate age, but also for special populations who are allergic to antibiotics, with immune deficiency, with immune dysfunction or undergoing immunosuppressive treatment, resulting a much broader population. IJEV is mainly approved and used in Europe, North America, and Japan, etc.

2. Excellent Immunogenicity

IJEV exhibits excellent immunogenicity with an average of over 90% seroconversion rate in the phase III clinical trial in China, and with 100% in Thai clinical trial.

3. Purity and Safety

IJEV eliminates the potential risks of allergies and other adverse reactions by removing ingredients including antibiotics, gelatin and others from its formulation. β-propiolactone is employed instead of formaldehyde in the production process, which not only enables more thorough virus inactivation for the vaccine, but also has β-propiolactone hydrolyzed into a common compound harmless to humans. Vero cells are utilized as the cell matrix, which can be cultured in a bioreactor without the need of animal slaughter. Consequently, the quality of cultured cells is easier to be controlled, and the likelihood of the potential contamination is lower during in the culture process.

Clinical Trial Data

1. Large-scale Safety Observation

  Responsible unit: National Immunization Program, Center of Disease Control and Prevention (CDC), China

  Sites: One or two districts (or counties) are selected in each of the provinces of Jiangsu, Zhejiang, Yunnan and Ningxia

  Subjects: 3608 healthy children aged from 8 months to 2 years old

  Conclusion:

(1) Subjects aged 8 months: Upon the vaccination with IJEV, the main symptoms are mild to moderate fever, and local reactions mainly characterized by redness and swelling with no serious adverse reaction. The incidence of adverse reaction of the second dose was lower than that of the first dose.

(2) Subjects aged 2: Upon the vaccination with IJEV or live attenuated Japanese encephalitis vaccine, there were no local adverse reaction except mild to moderate fever observed as systemic adverse reactions. There was no statistical significance between the two.

—Yin Zundong, et al. Chinese Journal of Vaccines and Immunization, 2011, 17 (3): 195-200.

2. Safety Assessment of Sequential Immunization with Two Japanese Encephalitis Vaccines

  Responsible unit: Center of Disease Control and Prevention (CDC), Tianjin City

  Subjects: 5019 healthy children aged from 9 months to 2 years old

  Conclusion: Sequential immunization with live-attenuated JE vaccine and inactivated JE vaccine shows good safety

—Li Yongcheng, et al. Chinese Journal of Vaccines and Immunization, 2011, 17 (2): 155-157.

Phase III clinical serological study of IJEV

IJEV exhibits excellent immunogenicity, which is significantly higher than that of similar domestic products

—Zhou Libao, et al. Chinese Journal of Biologicals, 2009, 22 (8): 809-811.