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Trial Results: Immunology/Infectious Disease

Tuesday, October 7, 2008 11:02 AM

Crucell and Sanofi Pasteur reported positive preliminary results from a phase II trial of CL-184, a vaccine for the treatment of rabies. This randomized, single-blind, controlled study enrolled 140 healthy subjects in the United States. The subjects received CL-184, a currently marketed human rabies immune globulin (HRIG) or placebo plus rabies vaccine.

The neutralizing activity against the rabies virus was comparable to that provided by the HRIG. By Day 14, all subjects administered the monoclonal antibodies combination together with the rabies vaccine reached the level of 0.5 IU/ml, a neutralizing activity level thought to provide protection. The development of the immune response to the rabies vaccine was comparable in the monoclonal antibody combination and the human rabies immune globulin groups.

The vaccine was well-tolerated. There were no serious adverse events reported and most adverse events were mild or moderate in severity.

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