MAPREC for control of the consistency of production of type-3 poliovirus vaccine live oral (OPV) was completed in FY 98, and results were presented to the WHO Expert Committee on Biological Standardization in October FY 99 to consider as a recommended preliminary test preceding neurovirulence tests in monkeys and as an acceptable alternative to monkey testing for type-3 OPV. Reference materials (standard cDNA and reference type-2 poliovirus) were prepared at CBER and validated by the WHO Collaborative Study. The results of the Study were discussed and approved in 1999 at a meeting of its participants. Reference preparations of cDNA and poliovirus for MAPREC test for type-1 OPV were prepared and validated by internal CBER study. The samples were sent to NIBSC for ampouling. Now the ampouled materials are being tested at CBER before they will be sent to WHO Study participants for tests. After the Study is completed, its results will be submitted to ECBS for approval (fall 2001). The project will be continued in FY 01.

Agency
National Institute of Health (NIH)
Institute
Center for Biologics Evaluation and Resarch - Viral Products (CBERVP)
Type
Intramural Research (Z01)
Project #
1Z01BK008001-11
Application #
6436165
Study Section
(LAMD)
Project Start
Project End
Budget Start
Budget End
Support Year
11
Fiscal Year
2000
Total Cost
Indirect Cost