A novel site-II directed glycoprotein estimation ELISA to aid rabies vaccine manufacture for veterinary and human use

作者：Abhinay Gontu; Dessain Scott; Srikanth Adabala; Senthilkumar R L; Vidyasagar Pitta; Praveen Alagangula; Reddy R V Chandrasekhar; Reddy Erri Swapna; Rajendra Lingala^*

来源：Vaccine, 2014, 32(2): 209-213.

DOI：10.1016/j.vaccine.2013.11.026

• Rabies vaccines
• Avidin-biotin complex ELISA
• Glycoprotein
• Antigenic site-ll
• Mouse potency

Although the World Health Organization recommends the use of in vitro techniques to qualify rabies vaccine lot release, very limited proposals have been made to arrive at a harmonized approach for wide scale usage. The present study proposed and evaluated the use of a novel avidin biotin ELISA as an alternative to these in vivo tests in rabies vaccine manufacture. This assay utilized a neutralizing pan reactive monoclonal antibody (mAb) reactive with the conserved site-II of the natively folded rabies glycoprotein. Linear regression analysis of the in vitro glycoprotein estimates with the in vivo potency values, showed a good correlation (r(2) = 0.8) with veterinary vaccines, but a poor correlation (r(2) = 0.2) with human vaccines. However, we could qualitatively arrive at cut-off glycoprotein estimates from the ELISA, above which all the vaccines were declared to be protective by mouse challenge studies (>2.5 IU/dose).

• 出版日期2014-1-3
• 单位河北医科大学