Development and validation of an egg-based potency assay for a trivalent live attenuated influenza vaccine

作者：Yeolekar Leena R; Dhere Rajeev M^*

来源：Biologicals, 2012, 40(2): 146-150.

DOI：10.1016/j.biologicals.2011.10.002

• Live attenuated influenza vaccine
• Potency
• Egg infectious dose

Live attenuated influenza vaccines (LAIVs) targeting seasonal influenza are produced in embryonated eggs and formulated as a trivalent preparation of three live attenuated vaccine strains, one A(H1N1) strain, one A(H3N2) strain and one type B strain. In this study, we describe an egg-based potency assay for estimating the 50% Egg infectious dose (EID50) of individual strains in the trivalent preparation by selective neutralisation of two strains and then estimating the infective titres of the non-neutralised strain. The test is highly specific, and no cross interference of heterologous antisera is observed in the estimation of individual titres. Individual strains with titres in the range of 6.5-7.0 log EID50 per 0.5 ml show intra-assay and inter-assay coefficients of variance ranging from 1.25% to 2.95%. This assay was developed to establish a simple, reliable and inexpensive egg-based assay for estimating the potency of individual strains in a trivalent preparation.

• 出版日期2012-3