Safety and immunogenicity of Lyssavac Berna human diploid cell rabies vaccine in healthy adults.

A clinical trial testing the safety and immunogenicity of a newly developed human diploid cell rabies vaccine (Lyssavac-HDC) was conducted on subjects at three colleges of veterinary medicine in the United States. Lyssavac-HDC is a sterile lyophilized vaccine containing no antibiotics or preservatives and is administered intramuscularly as a 0.5 ml dose of vaccine containing at least 2.5 i.u. of rabies inactivated antigen per dose. Subjects were given either a three dose pre-exposure series (days 0, 7, and 28), followed by one booster dose of vaccine (day 360); or a five dose simulated post-exposure series of injections (days 0, 3, 7, 14, and 28). All subjects in the post-exposure and pre-exposure groups possessed adequate levels of rabies neutralizing antibody (> or = 5) when tested on day 14 and day 28, respectively. Subjects in the pre-exposure group demonstrated a vigorous anamnestic response after the administration of one booster dose of vaccine on day 360. The type and severity of local and systemic reactions observed were comparable to other primary cell culture rabies vaccines. Significantly, there were no type III hypersensitivity reactions reported in subjects previously immunized with Lyssavac-HDC after the administration of a booster dose of vaccine on day 360.