title: An open-label, single arm, phase III clinical study to evaluate the efficacy and safety of CJ smallpox vaccine in previously vaccinated healthy adults.
abstract: BACKGROUND
  The increased possibility of bioterrorism has led to reinitiation of smallpox vaccination. In Korea, more than 30 years have passed since the last smallpox vaccinations, and even people who were previously vaccinated are not regarded as adequately protected against smallpox. We evaluated the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy adults previously vaccinated against smallpox.
  
  
  METHODS
  We conducted an open label, single arm, phase III clinical trial to evaluate the efficacy and safety of CJ-50300. Healthy volunteers, previously vaccinated against smallpox, born between 1950 and 1978 were enrolled. CJ-50300 was administered with a bifurcated needle over the deltoid muscle according to the recommended method. The rate of the cutaneous take reaction, humoral immunogenicity, and safety of the vaccine was assessed.
  
  
  RESULTS
  Of 145 individuals enrolled for vaccination, 139 completed the study. The overall rates of cutaneous take reactions and humoral immunogenicity were 95.0% (132/139) and 88.5% (123/139), respectively. Although 95.9% (139/145) reported adverse events related to vaccination, no serious adverse reactions were observed.
  
  
  CONCLUSIONS
  CJ-50300 can be used safely and effectively in healthy adults previously vaccinated against smallpox.
authors.affiliation: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: Nak-Hyun
authors.initials: NH
authors.lastname: Kim
authors.forename: Yu Min
authors.initials: YM
authors.lastname: Kang
authors.forename: Gayeon
authors.initials: G
authors.lastname: Kim
authors.forename: Pyoeng Gyun
authors.initials: PG
authors.lastname: Choe
authors.forename: Jin Su
authors.initials: JS
authors.lastname: Song
authors.forename: Kwang-Hee
authors.initials: KH
authors.lastname: Lee
authors.forename: Baik-Lin
authors.initials: BL
authors.lastname: Seong
authors.forename: Wan Beom
authors.initials: WB
authors.lastname: Park
authors.forename: Nam Joong
authors.initials: NJ
authors.lastname: Kim
authors.forename: Myoung-don
authors.initials: MD
authors.lastname: Oh
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007117:Immunization, Secondary / Q000009:adverse effects* / Q000379:methods*; D007723:Korea; D008297:Male; D008875:Middle Aged; D012899:Smallpox / Q000276:immunology / Q000517:prevention & control*; D012900:Smallpox Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D012900:Smallpox Vaccine
keywords: Efficacy; Immunogenicity; Smallpox vaccine