Human vaccines · 2011
The immunogenicity and safety of vaccination with purified Vero cell rabies vaccine (PVRV) in China under a 2-1-1 regimen.
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Liu Huazhang, Huang Guihua, Tang Qing, Li Jia, Cao Shouchun, Fu Chuanxi, Cao Qing, Liu Beiyan, Pan Huai, Wang Ming
Аннотация
BACKGROUND: In China, rabies vaccine is only permitted to use under the Essen 5-dose regimen for the rabies post-exposure prophylaxis (PEP). However, Purified chick embryo cell vaccine made in India (Rabipur) has been approved in use under 2-1-1 immune program in 2010. Our objective is to confirm the immunogenicity and safety of PVRV manufactured in China (SPEEDA) under 2-1-1 program, compared with Rabipur and with the Essen 5-dose regimen.
METHODS: A total of 112 subjects were divided into three groups: 50 subjects in test group A, 32 subjects in control group B and 30 subjects in control group C. "Zagreb" 2-1-1 program was chosen for group A and B using SPEEDA and Rabipur, "Essen" 5-dose regimen was adopted for group C using SPEEDA, thus to observe the general and local reactions within 72 h post vaccination. Serum samples were also collected at D0, D7, D14 and D45 to determine the rabies serum neutralizing antibody by rapid fluorescent focus inhibition test (RFFIT).
RESULTS: All groups showed similar immunogenicity. The neutralizing antibody titers at D14 and D45 of all subjects showed more than 0.5 IU/ml. No moderate and severe adverse effects were observed, though mild adverse reactions may occur.
CONCLUSIONS: PVRV (SPEEDA), under 2-1-1 regimen, is equally safe and immunogenic as the PCECV (Rabipur) for post-exposure prophylaxis vaccination.
METHODS: A total of 112 subjects were divided into three groups: 50 subjects in test group A, 32 subjects in control group B and 30 subjects in control group C. "Zagreb" 2-1-1 program was chosen for group A and B using SPEEDA and Rabipur, "Essen" 5-dose regimen was adopted for group C using SPEEDA, thus to observe the general and local reactions within 72 h post vaccination. Serum samples were also collected at D0, D7, D14 and D45 to determine the rabies serum neutralizing antibody by rapid fluorescent focus inhibition test (RFFIT).
RESULTS: All groups showed similar immunogenicity. The neutralizing antibody titers at D14 and D45 of all subjects showed more than 0.5 IU/ml. No moderate and severe adverse effects were observed, though mild adverse reactions may occur.
CONCLUSIONS: PVRV (SPEEDA), under 2-1-1 regimen, is equally safe and immunogenic as the PCECV (Rabipur) for post-exposure prophylaxis vaccination.