VALIDATION OF THE POTENCY TESTING PROCEDURE FOR THE SHINGRIX VACCINE BY ELISA METHOD

Abstract

Shingrix is a recombinant, non-live subunit vaccine containing glycoprotein E of the Varicella–zoster virus, formulated with the AS01B adjuvant system. It is indicated for the prevention of herpes zoster and related complications in adults aged 50 years and older. In Vietnam, the vaccine has been registered and quality-controlled by the National Institute for Control of Vaccines and Biologicals. Potency testing is a critical parameter in vaccine quality assessment. This study aimed to validate an ELISA-based method for the quantification of gE antigen. The validation parameters included accuracy, precision, and linearity. The results demonstrated acceptable accuracy, with t = 0.14 < t_α = 4.303. Precision was confirmed with CV values of 5.48% (repeatability) and 4.90% (intermediate precision), both below 20%. Linearity was achieved with R² = 0.9519; 0.9824; 0.963, 0.95 ≤ R² ≤1 ,  bias (Δi) ranging from –3.95% to 6.78%, within ±15%. The validated ELISA method is suitable for routine quantification of gE antigen in the vaccine.