[Clinical trial of YU BHK Rabivak vaccine against rabies in volunteers].
The BHK (baby hamster kidney) continual cell line has been used for years in the production of rabies vaccine for animals. Becouse of the rich harvesting of rabies virus from this cell substrate, there is no need of the an additional virus concentration, so that the vaccine production can be organised in small local Pasteur Institutes as well. Although its long-range use in the veterinary medicine has proved that the BHK line is safe and that the vaccine is immunogenic, its use in the human medicine has been only recently studied. According to the latest recommendations of the Expert Committee for the Biological Standardisation of the WHO from 1998, residual cellular DNA in the vaccine is not a potential risk because the inactivation of the vaccine by the beta-propiolactone completely inactivates its possible biologic activity. In the work, the authors report the results of the third phase of the clinical trail of the YU BHK Rabivak vaccine on volunteers. The rabies vaccine studied, named YU BHK Rabivak, produced by Novi Sad Pasteur Institute, caused the generation of protective titre of virus-neutralising antibodies in all examinees: in 96.4% after 2 doses, in 99% after 3 doses, and in 100% after 4 and 5 doses of the vaccine. The registered side effects were expected, mild, did not need medical treatment, and were not more frequent than in the case of other vaccines from cell culture.
Lalosević
V
V
Lazarević-Ivanc
L
L
Lalosević
D
D
D000328:Adult; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002460:Cell Line; D006224:Cricetinae; D005260:Female; D006801:Humans; D007668:Kidney; D008297:Male; D008875:Middle Aged; D011818:Rabies / Q000517:prevention & control; D011819:Rabies Vaccines / Q000009:adverse effects / Q000276:immunology*; D011820:Rabies virus / Q000276:immunology
D000914:Antibodies, Viral; D011819:Rabies Vaccines