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 (1.0x10(8) and 1.0x10(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: NCT00607243].
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Hee-Chang
authors.initials: HC
authors.lastname: Jang
authors.forename: Choong Jong
authors.initials: CJ
authors.lastname: Kim
authors.forename: Kye Hyoung
authors.initials: KH
authors.lastname: Kim
authors.forename: Kwang-Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Young-Ho
authors.initials: YH
authors.lastname: Byun
authors.forename: Baik-Lin
authors.initials: BL
authors.lastname: Seong
authors.forename: Giulietta
authors.initials: G
authors.lastname: Saletti
authors.forename: Cecil
authors.initials: C
authors.lastname: Czerkinsky
authors.forename: Wan Beom
authors.initials: WB
authors.lastname: Park
authors.forename: Sang-Won
authors.initials: SW
authors.lastname: Park
authors.forename: Hong-Bin
authors.initials: HB
authors.lastname: Kim
authors.forename: Nam Joong
authors.initials: NJ
authors.lastname: Kim
authors.forename: Myoung-don
authors.initials: MD
authors.lastname: Oh
mesh_terms: D000328:Adult; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007111:Immunity, Cellular; D056724:Immunity, Humoral; D008297:Male; D009500:Neutralization Tests; D012899:Smallpox / Q000517:prevention & control*; D012900:Smallpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D055815:Young Adult
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D012900:Smallpox Vaccine