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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

Cited 5 time in Web of Science Cited 5 time in Scopus
Authors
Jang, Hee-Chang; Kim, Choong Jong; Kim, Kye Hyoung; Lee, Kwang-Hee; Seong, Baik-Lin; Czerkinsky, Cecil; Park, Sang-Won; Kim, Nam Joong; Oh, Myoung-don; Kim, Hong-Bin; Park, Wan Beom; Saletti, Giulietta; Byun, Young-Ho
Issue Date
2010-08-16
Publisher
ELSEVIER SCI LTD
Citation
VACCINE; Vol.28 36; 5845-5849
Keywords
Smallpox vaccineEfficacyImmunity
Abstract
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.
ISSN
0264-410X
Language
English
URI
https://hdl.handle.net/10371/76457
DOI
https://doi.org/10.1016/j.vaccine.2010.06.063
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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