4.5 Article

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

期刊

VACCINE
卷 28, 期 36, 页码 5845-5849

出版社

ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2010.06.063

关键词

Smallpox vaccine; Efficacy; Immunity

资金

  1. CJ CheilJedang Corporation (Seoul, Republic of Korea)

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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]. (C) 2010 Elsevier Ltd. All rights reserved.

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