The D-antigen of Poliovirus particles is the protective antigen in humans and vaccination with either oral Polio vaccine (OPV)or inactivated (IPV) will induce protective antibodies against this antigen containing Polio Virus infection. The potency of IPV is the amount of D-antigen present in a given vaccine preparation and is determined by either a monkey serological test or anELISA assay using type-specific monoclonal or polyclonal antisera. Monkey serological tests are very expensive to perform on a routine basis and are not very accurately quantitative. On the other hand, type-specific ELISA tests are easily performed and give accurate, quantitative potency values. However, the success of this ELISA procedure depends on the reference antigen and antisera used in the test and hence needs standardization. Previous studies with monoclonal antibodies warranted further improvement or the evaluation and standardization of alternative ELISA protocols. The goal of this research project is to develop a suitable ELISA method using polyclonal antisera for IPV potency determinations that is acceptable to CBER and various manufacturers of IPV. Inactivated Polio Virus vaccine (IPV) is approved by FDA and is becoming more popular as a childhood vaccine, in addition to Oral Polio Vaccine (OPV). CBER of FDA has the responsibility of testing the potency of different lots of IPV produced by various manufacturers to strictly regulate the lot-to-lot variability of different IPV vaccines to make a safe and effective dose of the vaccine available to genneral public. In this project, research is being pursued in order to develop an improved potency assay for IPV. Development of a standardized ELISA that is broadly applicable for IPV from different manufacturers and that would improve quantitative analysis of IPV potency determination is very important to carry out the goals of the mission. An improved and standardized ELISA method for IPV potency helps in eliminating the batches of subpotent vaccines and provide the general public with a better vaccine.
