title: Expert examination of the immunogenic activity and toxicity of the pertussis component of adsorbed and non-adsorbed diphtheria-tetanus-pertussis vaccines. Results of interlaboratory investigations under the WHO project "Reactogenicity and Toxicity of DPT Vaccines".
abstract: Since the DPT vaccine is broadly used for the prevention of diphtheria, tetanus and pertussis' its preparations should meet special quality requirements. The present study was aimed at evaluating the reproducibility of laboratory methods utilized to assess the protective activity and toxicity of the pertussis component as well as at examining the feasibility of expert estimations of product quality to enhance the validity of findings. The results of interlaboratory comparative examination of quality parameters of the tested preparations revealed that the routine laboratory quality control methods were not sufficiently standardized as their application in different laboratories did not always produce identical results. The WHO criteria to evaluate the toxicity of pertussis vaccines are far from perfect since vaccines with pronounced toxicity can only be distinguished from those with moderate to mild toxicity after the administration to tested mice of vaccines at a single infant dose of 0.5 ml. To enhance the reproducibility of methods employed in the laboratory, appropriate standard specimens of the preparation should be used serving as a measure of different quality parameters; all test conditions should be also standardized as far as possible. To enable objective quality evaluation of medical biological preparations, the degree of experiment reproducibility should be regularly verified in interlaboratory tests on an international scale as well as inside those countries which have several manufacturers of a given preparation. It appears expedient to set up an international system of expert evaluation of quality of biological preparations by appointing several regional and national centres which meet the requirements for expert laboratories.
authors.affiliation: L.A. Tarasevich State Research Institute for the Standardization and Control of Medical Biological Preparations, Moscow, USSR.
authors.forename: B D
authors.initials: BD
authors.lastname: Bytchenko
authors.forename: R P
authors.initials: RP
authors.lastname: Chuprinina
authors.forename: N S
authors.initials: NS
authors.lastname: Zakharova
mesh_terms: D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000276:immunology / Q000633:toxicity; D006632:Histamine / Q000276:immunology; D011786:Quality Control; D015203:Reproducibility of Results; D014944:World Health Organization
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D006632:Histamine