Studies on the Potency Test of Hb Vaccine by the Parallel Line Assay Method in Guinea Pigs

Abstract

SUMMARY:The parallel line assay method was applied on the potency test of HB vaccine in guinea pigs. The applicability of the method was investigated to obtain information on the possible effect of inactivation process of HBs antigen, on the magnitude of adjuvant effect of aluminum compound and so on. The precision of the method was found to be comparable to those of diphtheria and tetanus toxoids.

Studies on the in Vitro Antigenicity Test of the Hepatitis B Surface Antigen Preparation and Its Relationship to the in Vivo Potency Estimate

“…No deviation from linearity was observed for the six regression lines and the heteroscedasticity of the variances for the six preparations was not significant (addendum to Table I). The relative antigenicities with their confidence limits of the five inactivated antigens to that of HBAgII are summarized in Table II together with the relative potencies obtained in in vivo experiments by Takahashi et al (1982). The results of in vitro test appear to reflect fairly well those in vivo ones.…”

“…No significant deviations from the linearity and parallelism of the regression lines were demonstrated. The antigenicity of A-7 relative to that of TV-1 is presented in Table V together with its relative potency obtained by in vivo experiments (Takahashi et al, 1982). Though the relative antigenicity and the relative potency were 2.398 and 2.842, respectively, the corrected relative values based on the ratio of the protein content of TV-1 to that of A-7 …”

“…The Project Team decided to employ a combined treatment for inactivation to secure the safety of the vaccine to be used by the Team (Takahashi et al, 1982). The in vivo tests suggested that the combined treatment might have affected the potency to a certain extent (Takahashi et al, 1982).…”

“…The in vivo tests suggested that the combined treatment might have affected the potency to a certain extent (Takahashi et al, 1982). Therefore, the effect of the combined treatment on the in vitro antigenicity was assessed.…”

“…We established a method for potency test of HB vaccine in guinea pigs, and the potency of each vaccine preparation can be estimated as a relative value to that of a reference vaccine (Takahashi et al, 1982) by applying the parallel line assay method (Finney, 1964). The use of a stable and standardized reference preparation is profitable to minimize possible between-assay variation.…”