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

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

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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 (1.0×108 and 1.0×107 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].

Original languageEnglish
Pages (from-to)5845-5849
Number of pages5
JournalVaccine
Volume28
Issue number36
DOIs
Publication statusPublished - 2010 Aug

All Science Journal Classification (ASJC) codes

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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    Jang, H. C., Kim, C. J., Kim, K. H., Lee, K. H., Byun, Y. H., Seong, B. L., Saletti, G., Czerkinsky, C., Park, W. B., Park, S. W., Kim, H. B., Kim, N. J., & Oh, M. D. (2010). 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. Vaccine, 28(36), 5845-5849. https://doi.org/10.1016/j.vaccine.2010.06.063