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[Studies on clinical trials and immune effect of a new purified rabies vaccine prepared from Vero cells].

OBJECTIVE
To observe the safety and neutralizing antibody response of a new purified rabies vaccine prepared from Vero cells.


METHODS
The vaccine used was manufactured in Hainan Institute of Biologicals and licensed by the Ministry of Health for clinical trials. The vaccine was administrated in 30 and 318 volunteers during phase I and II clinical trials with preexposure (day 0, 7, and 28) or post exposure (day 0,3,7,14 and 28) vaccination schedules. The "Verorab (PVRV)", a rabies vaccine made in France was used as control.


RESULTS
The results showed that the new purified vaccine did not cause any severe and moderate side reactions, the slight side reaction rate was 12% including those complained by vaccines themselves. The immunological effect was determined by detecting neutralizing antibody with mouse neutralization test (NIH). The positive seroconversion rates of neutralizing antibody were 100% (n= 27, GMT 2.89 IU/ml) and 100% (n= 30, GMT 5.29 IU/ml) respectively by pre- exposure and post exposure schedules. No significant difference was found when compared with France "Verorab" vaccine by preexposure schedule (n= 24, GMT 2.13 IU/ml).


CONCLUSIONS
The clinical trials indicated that the purified rabies vaccine prepared from Vero cells only showed slight side reaction and had good neutralizing antibody response. Therefore this new vaccine is safe and protective for the prevention of rabies in human.