Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Vaccine. 2010 Aug 16;28(36):5845-9. doi: 10.1016/j.vaccine.2010.06.063. Epub 2010 Jun 30.
A randomized, double-blind, controlled clinical trial was conducted to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, and to determine its minimum effective dose. The overall rates of cutaneous "take" reaction and humoral and cellular immunogenicity in CJ-50300 vaccinees were 100% (123/123), 99.2% (122/123), and 90.8% (109/120), respectively, and these rates did not differ significantly between the conventional-dose and the low-dose CJ-50300 (1.0x10(8) and 1.0x10(7) plaque-forming units/mL, respectively) (P>0.05 for each). No serious adverse reaction was observed. However, one case of possible generalized vaccinia occurred in the conventionally dosed group [ClinicalTrials.gov Identifier: NCT00607243].
一项随机、双盲、对照的临床试验评估了新型细胞培养痘苗疫苗 CJ-50300 的疗效和安全性，并确定了其最小有效剂量。CJ-50300 疫苗接种者的皮肤“接种”反应、体液和细胞免疫原性的总发生率分别为 100%（123/123）、99.2%（122/123）和 90.8%（109/120），而常规剂量和低剂量 CJ-50300 组（分别为 1.0x10(8)和 1.0x10(7)噬菌斑形成单位/mL）之间的这些比率无显著差异（各 P>0.05）。未观察到严重不良反应。然而，在常规剂量组中发生了 1 例可能的全身性牛痘病例[ClinicalTrials.gov 标识符：NCT00607243]。
