A randomized, double-blind, controlled clinical trial to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy volunteers

作者：Jang Hee Chang; Kim Choong Jong; Kim Kye Hyoung; Lee Kwang Hee; Byun Young Ho; Seong Baik Lin; Saletti Giulietta; Czerkinsky Cecil; Park Wan Beom; Park Sang Won; Kim Hong Bin; Kim Nam Joong; Oh Myoung don^*

来源：Vaccine, 2010, 28(36): 5845-5849.

DOI：10.1016/j.vaccine.2010.06.063

• Smallpox vaccine
• Efficacy
• Immunity

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 (1.0 x 10(8) and 1.0 x 10(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: NCT006072431].

• 出版日期2010-8-16