SAFETY AND IMMUNOGENICITY OF RABIES VACCINE SURE RAB TM (BIOMED) AND VERORAB TM (SANOFI PASTEUR).

Rabies is the most dreaded zoonotic disease. Modern cell culture derived vaccines have been used for pre bite and post bite immunization. SURE RAB TM has been manufactured by BIOMED (P) Ltd. in Vero cells using Pitman Moore strain of Rabies virus. The clinical study was done to test the safety and immunogenicity of SURE RAB TM in pre and simulated post bite vaccination schedules for intramuscular (I/M) and intradermal (I/D) vaccination. VERO RAB manufactured by Aventis Pasteur was used for comparison. One hundred ninety four healthy volunteers who gave informed consents participated in the study at three centers: Meerut (U.P.), Aligarh (U.P.) and Bhavnagar (Gujarat). The volunteers were divided in seven groups who were vaccinated with either vaccine as per pre bite (I/M & I/D) or post bite (I/M & I/D - 2 Nos.) schedules. The reactogenicity was noted and immunogenicity was evaluated at 0, 7 &/or 14, 28-30 & 45 days of vaccination by ELISA test (BIO RAD) and RIFFIT tests. Both the vaccines were found to be minimally reactogenic and conferred equally good immune responses which far exceeded the WHO's requirements of ≥ 0.5 I.U. per ml. SURE RAB TM and VERO RAB proved equally safe and immunogenic when used as I/M or I/D schedules of vaccination. Statistically insignificant differences (95% C.I.) in immune response induced by three consecutive batches of SURE RAB TM validated the