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.
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].
Jang
Hee-Chang
HC
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Kim
Choong Jong
CJ
Kim
Kye Hyoung
KH
Lee
Kwang-Hee
KH
Byun
Young-Ho
YH
Seong
Baik-Lin
BL
Saletti
Giulietta
G
Czerkinsky
Cecil
C
Park
Wan Beom
WB
Park
Sang-Won
SW
Kim
Hong-Bin
HB
Kim
Nam Joong
NJ
Oh
Myoung-don
MD
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
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D012900:Smallpox Vaccine