Safety and immunogenicity of SURE RAB™, an inactivated cell culture derived rabies vaccine: A comparative, phase III clinical trial

Abstract

IntroductionRabies is a viral zoonotic disease widespread across the world. In India, various cell culture vaccines are available for pre and post exposure prophylaxis (PEP) but are not sufficient to meet the rising demand. The present study evaluated the safety and immunogenicity of Rabies vaccine Human I.P. (Brand name: SURE RAB™) in PEP and demonstrated its non-inferiority to already approved rabies vaccine (Brand name: VERORAB). Material and methodsIt was a phase-III randomized, open label, comparative, single centre clinical trial in post exposure subjects. Safety and immunogenicity were evaluated at Day 0, 14 and 45 ± 7 post vaccination. Day 14 serum samples were analyzed by Enzyme Linked Immunesorbent assay (IgG ELISA, Bio-Rad) and Day 0, 14 and 45 ± 7 serum were tested by Rapid Fluorescent Focus Inhibition Test (RFFIT). Paired t-test was applied to compare the results of Rabies virus neutralizing antibody (RVNA). The severity of adverse reactions was measured on a scale of excellent, good, fair and bad; p-value (p < 0.05) was considered as statistically significant. ResultsAll the subjects achieved a protective titer value between 0.5 and 9.0 IU/ml by Day 14 tested by ELISA and significant rise in the antibody titer in all the groups when tested after 45 days. Statistically significant p-value (p < 0.001) observed with RFFIT test indicated biological potency of rabies vaccine. Adverse events and safety was comparable statistically between three groups (p ​= ​0.886) and Group I ​+ ​II combined versus Group III (p = 0.495). ConclusionThe study results conclusively demonstrate that SURE RAB™ is comparable to VERORAB in terms of safety and immunogenicity and can be used for PEP in rabies.