Collaborative study on a Guinea pig serological method for the assay of acellular pertussis vaccines.

An international collaborative study (coded BSP083) was performed under the aegis of the Biological Standardisation Programme supported by the Council of Europe and the European Commission, with the aim of replacing the in vivo challenge assays for potency determination of combined acellular pertussis (aP) vaccines by a refined procedure also allowing reduction of animal use. This study investigates whether the immunogenicity of aP vaccine components could be assayed in a guinea pig (gp) serology model, using the same vaccine immunising doses as for D and T components potency testing, instead of using separate animals as is currently done. The BSP83 project is a follow up of 3 former collaborative studies (coded BSP019, BSP034 and BSP035) on serological methods for the potency testing of tetanus (T) and diphtheria (D) vaccines for human use.

Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccine (part 2).

The study is a contribution to the EDQM's efforts to meet some of the expectations of the 3 Rs: Replacement, Reduction and Refinement of animal assays as proposed by Russell and Burch in 1959 and adopted by the European Union in 1986, and specifically to validate alternative assays to replace, for batch-release purposes, the European Pharmacopoeia (Ph. Eur.) in vivo direct challenge procedures for the potency determination of diphtheria toxoid vaccines.

Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccines - extended study: correlation of serology with in vivo toxin neutralisation.

Phase I of BSP034 collaborative study was extended in two laboratories to include correlation of serology with in vivo toxin neutralisation test (TNT) using 2 separate sets of 20 serum pools, produced in-house. The study investigated the extent to which the in vitro methods for diphtheria antibodies, Vero cell assay and diphtheria enzyme-linked immunosorbent assay for diphtheria antitoxin (D-ELISA), can detect neutralising antibodies by comparison with TNT in guinea pigs. The study was also performed to compare the antibody neutralising potency obtained in relation to guinea pig (GP) or equine (DI) antitoxin standard.

Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccines-part 1.

A collaborative study on the evaluation of an alternative functional assay, the Vero cell method, to the Ph. Eur. in vivo challenge procedures for potency determination of diphtheria toxoid in 6 different combined vaccines was initiated in January 2001.

A Vero cell method for potency testing of diphtheria vaccines.

A collaborative study on the evaluation of an alternative functional assay to the Ph. Eur. in vivo challenge procedure for potency determination of diphtheria toxoid vaccines was initiated in January 2001.