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

doi:10.1016/j.vaccine.2010.06.063

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

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

12 Scopus citations

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 language	English
Pages (from-to)	5845-5849
Number of pages	5
Journal	Vaccine
Volume	28
Issue number	36
DOIs	https://doi.org/10.1016/j.vaccine.2010.06.063
State	Published - Aug 2010

Bibliographical note

Funding Information:
This study was supported by CJ CheilJedang Corporation (Seoul, Republic of Korea).

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Efficacy
Immunity
Smallpox vaccine

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10.1016/j.vaccine.2010.06.063

Cite this

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

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title = "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",

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].",

keywords = "Efficacy, Immunity, Smallpox vaccine",

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

note = "Funding Information: This study was supported by CJ CheilJedang Corporation (Seoul, Republic of Korea). ",

year = "2010",

month = aug,

doi = "10.1016/j.vaccine.2010.06.063",

language = "English",

volume = "28",

pages = "5845--5849",

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issn = "0264-410X",

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Jang, HC, Kim, CJ, Kim, KH, Lee, KH, Byun, YH, Seong, BL, Saletti, G, Czerkinsky, C, Park, WB, Park, SW, Kim, HB, Kim, NJ & Oh, MD 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, vol. 28, no. 36, pp. 5845-5849. https://doi.org/10.1016/j.vaccine.2010.06.063

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T1 - 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

AU - Jang, Hee Chang

AU - Kim, Choong Jong

AU - Kim, Kye Hyoung

AU - Lee, Kwang Hee

AU - Byun, Young Ho

AU - Seong, Baik Lin

AU - Saletti, Giulietta

AU - Czerkinsky, Cecil

AU - Park, Wan Beom

AU - Park, Sang Won

AU - Kim, Hong Bin

AU - Kim, Nam Joong

AU - Oh, Myoung don

N1 - Funding Information: This study was supported by CJ CheilJedang Corporation (Seoul, Republic of Korea).

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AB - 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].

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KW - Smallpox vaccine

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ER -

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

Abstract

Bibliographical note

UN SDGs

Keywords

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