1. The immunogenicity and safety of vaccination with purified vero cell rabies vaccine (PVRV) in China under a 2-1-1 regimen
來源：本站 日期：2015-07-14
廣州CDC臨床研究顯示，成大速達5針法和“2-1-1”程序均有良好的免疫原性和安全性?！?-1-1”程序比5針法早期抗體產生更快，滴度更高。
Hum Vaccin. 2011 Feb;7(2):220-4. Epub
2011 Feb 1.
Liu H1, Huang G, Tang Q, Li J, Cao S, Fu C, Cao Q, Liu B, Pan H, Wang M.
· 1 Guangzhou Center for Disease Control and Prevention,
Guangzhou, Guangdong Province, China.
Abstract
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.
