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].

journal_name

Vaccine

journal_title

Vaccine

authors

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

doi

10.1016/j.vaccine.2010.06.063

subject

Has Abstract

pub_date

2010-08-16 00:00:00

pages

5845-9

issue

36

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(10)00885-6

journal_volume

28

pub_type

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