An immunogenicity and efficacy study of purified chick embryo cell culture rabies vaccine manufactured in Japan.

Purified chick embryo cell rabies vaccine manufactured by the Chemo-Sero-Therapeutic Institute(Kaketsuken) at Kumamoto, Japan (Kaketsuken) was submitted to an immunogenicity and efficacy study. 52 severely rabies exposed patients were treated with the conventional five doses intramuscular WHO approved ('Essen') postexposure schedule. This included the administration of 40 IU kg-1 of equine rabies immune globulin on Day 0. A control group of equally severely exposed subjects were treated with human diploid cell rabies vaccine manufactured by the Swiss Serum and Vaccine Institute as well as human rabies immune globulin. There were no deaths in either group in the more than 2 years follow-up period. Subjects treated with the chick embryo vaccine showed greater suppression of the neutralizing antibody response by the equine rabies immune globulin than those given the human diploid cell vaccine and human rabies immune globulin. A group of 20 less severely rabies exposed patients who received only the chick embryo vaccine without immune globulin all had antibody titers greater than the WHO minimal acceptable level on Day 14, 30, 90 and 180. Fourteen subjects among the severely exposed vaccine and immune globulin study group were given vaccine boosters on Day 180 because of low antibody titers. It is concluded that chick embryo rabies vaccine manufactured by Kaketsuken is an immunogenic and effective rabies vaccine, but that the potency of future batches must be increased to provide a greater safety margin.

Value of skin testing for predicting reactions to equine rabies immune globulin.

The high cost of postexposure prophylaxis for rabies is one reason that treatment is inadequate in developing countries. This problem has kindled interest in the use of equine rabies immune globulin, which is a less expensive, yet effective, substitute for human rabies immune globulin. Fatal anaphylaxis is a feared complication of the administration of heterologous serum; therefore, authoritative sources recommend prior skin testing. However, recommendations for methods of administering such a skin test and for its interpretation vary greatly. We embarked on a long-term study to develop guidelines for administration and interpretation of skin test results and to eventually determine a cost-benefit ratio. The skin test is not predictive of serum sickness. Anaphylaxis is rare with modern purified and pepsin-digested equine rabies immune globulins. We consider a skin test to be positive only if a wheal of > 10 mm in diameter, with or without flare, or a wheal of 5-10 mm in diameter with a flare of > 20 mm develops. Long-term studies will be required to answer the remaining questions regarding test criteria and cost benefits.