NCT00336635

Brief Summary

The currently available stock of smallpox vaccine would be insufficient in the face of an incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine is urgently needed because previous manufacturing methods using calf lymph are no longer acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by infecting MRC-5 cells. The aim of this phase 1 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

June 13, 2006

Last Update Submit

April 17, 2007

Conditions

Smallpox

Keywords

smallpox, vaccine, immunity

Outcome Measures

Primary Outcomes (1)

  • safety and immunogenicity

Interventions

cell-culture derived smallpox vaccineBIOLOGICAL

Eligibility Criteria

Age20 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Korean male and female subjects between 20 and 28 years of age at the time of screening visit.
  • Willing to participate and have signed the informed consent form
  • In good general health, without clinically skin diseases history, physical examination or laboratory test results
  • Hematocrit \>33% for women; \>38% for men
  • White cell count 3,300-12,000/mm3
  • Total lymphocyte count \> 800 cells/mm3

You may not qualify if:

  • Diseases or conditions that cause immunodeficiency (For examples; HIV AIDS, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, history of transplantation, therapy with alkylating agents, antimetabolites, radiation, or oral or parenteral corticosteroids).
  • In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency
  • history or present of eczema or atopic dermatitis
  • Allergy or sensitivity to any known components of vaccine or other medicines
  • In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis
  • Subjects with inflammatory ophthalmic disease requiring steroid therapy
  • Subjects who are planning for blood donations
  • Autoimmune disease such as lupus erythematosus
  • Subjects who work in medical institution
  • Household contacts with women who are pregnant or breast-feeding
  • Female Subjects who are pregnant or breast-feeding and have positive result by serum pregnancy test or urine pregnancy test, or do not using approved contraceptives such as sterilization, contraceptive ring injectable, combined oral contraceptive pills and barrier contraceptive, combined hormone-based therapy, contraceptive cream, contraceptive jelly, diaphragm or condoms
  • Subjects household member \<1 year old or work with children \<1 year old
  • Subjects with a known history of Cardiac disease or have three or more of the following risk factors: hyperpiesia, obesity, hyperlipidemia, glucosuria, sclerosis, cerebral arteriosclerosis
  • Receipt of immunoglobulin and steroid within 14 days of vaccination
  • Receipt of investigational research agents within 120 days of vaccination
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Kim SH, Choi SJ, Park WB, Kim HB, Kim NJ, Oh MD, Choe KW. Detailed kinetics of immune responses to a new cell culture-derived smallpox vaccine in vaccinia-naive adults. Vaccine. 2007 Aug 14;25(33):6287-91. doi: 10.1016/j.vaccine.2007.05.044. Epub 2007 Jun 11.

    PMID: 17597266DERIVED

MeSH Terms

Conditions

Smallpox

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Myoung-don Oh, MD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 13, 2006

First Posted

June 14, 2006

Study Start

June 1, 2006

Study Completion

February 1, 2007

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations

KR(1)