The immunogenicity and safety of vaccination with purified Vero cell rabies vaccine (PVRV) in China under a 2-1-1 regimen.

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.