Leparc-Goffart Isabelle, Poirier Bertrand, El Zaouk Annie, Tissier Marie-Hélène, Fuchs Florence
Agence Française de Sécurité Sanitaire des Produits de Santé, 69007 Lyon, France.
J Clin Microbiol. 2003 Aug;41(8):3687-9. doi: 10.1128/JCM.41.8.3687-3689.2003.
The potency of smallpox vaccines produced in the 1970s was tested by titration onto chorioallantoic membranes of fertilized hen eggs (CAM assay). The potency specification commonly approved for these vaccines was a titer above 10(8) pock-forming units per milliliter. We developed and validated a cell culture titration assay to have a more reliable potency test. The cell titration assay and the CAM assay were tested in parallel on 34 first-generation smallpox vaccine lots. These allowed us to demonstrate that a correlation does exist between the two titration techniques and to determine a new in-house specification for the cell titration method. This in vitro potency assay will allow us to test first-generation smallpox vaccines produced on the skin of living animals but will also give a hint of the potency specification that should be assigned for new generations of cell-derived smallpox vaccines.
20世纪70年代生产的天花疫苗效力通过滴定接种到受精鸡蛋的绒毛尿囊膜上进行测试（鸡胚绒毛尿囊膜试验）。这些疫苗通常批准的效力规格是每毫升滴度高于10(8)个痘疱形成单位。我们开发并验证了一种细胞培养滴定试验，以进行更可靠的效力测试。细胞滴定试验和鸡胚绒毛尿囊膜试验在34批第一代天花疫苗上进行了平行测试。这使我们能够证明两种滴定技术之间确实存在相关性，并确定细胞滴定法的新内部规格。这种体外效力测定法将使我们能够测试在活体动物皮肤上生产的第一代天花疫苗，但也将为新一代细胞衍生天花疫苗应指定的效力规格提供线索。
