Molecular consistency monitoring of live viral vaccines ♦ 823

Massively parallel sequencing for monitoring genetic consistency and quality control of live viral vaccines.

Intrinsic genetic instability of RNA viruses may lead to the accumulation of revertants during manufacture of live viral vaccines, requiring rigorous quality control to ensure vaccine safety. Each lot of oral poliovirus vaccine (OPV) is tested for neurovirulence in animals and also for the presence of neurovirulent revertants. Mutant analysis by PCR and restriction enzyme cleavage (MAPREC) is u...

A comparative study of two live measles vaccines in Iran

SFB 823 Monitoring multivariate variance changes

We propose a model-independent multivariate sequential procedure to monitor changes in the vector of componentwise unconditional variances in a sequence of p-variate random vectors. The asymptotic behavior of the detector is derived and consistency of the procedure stated. A detailed simulation study illustrates the performance of the procedure confronted with different types of data generating...

Microarray Techniques for Evaluation of Genetic Stability of Live Viral Vaccines

Evolutionary reversion of live viral vaccines: Can genetic engineering subdue it?

Attenuated, live viral vaccines have been extraordinarily successful in protecting against many diseases. The main drawbacks in their development and use have been reliance on an unpredictable method of attenuation and the potential for evolutionary reversion to high virulence. Methods of genetic engineering now provide many safer alternatives to live vaccines, so if live vaccines are to compet...