Skip to main content
OpenTrials
Completed

NCT Number: NCT00336635

Safety and Immunogenicity of CJ-50300

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • HBsAg seropositive
  • HCV antibody seropositive
  • HIV seropositive
  • Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
  • Blood donation within 12 weeks in advance screening visit
  • Subject who are not suitable to participate in study according to invesigator's judgement

Treatment and study plan

cell-culture derived smallpox vaccine

Biological

Primary outcomes

  1. safety and immunogenicity

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • HK inno.N Corporation

Registry information

Official study title

Randomized, Double Blind, Placebo Control Study to Evaluate the Safety and Immunogenicity of CJ-50300 in Healthy Volunteers : Phase I

Important dates

Study start
2006
Study completion
2007
First posted
Jun 14, 2006
Registry last updated
Apr 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.