Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers

NCT01056770 | Completed Phase 3 DMC

• 2 other identifiers: CJ_SPX_302CJ corporation
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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 are 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 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.

Conditions

Smallpox

Keywords

Smallpox vaccine efficacy

Outcome Measures

Primary Outcomes (2)

• Pocket formation

  7-9 day

• Adverse reactions

  0-28 days

Secondary Outcomes (1)

• Antibody response

  14 or 28 days

Study Arms (1)

Vaccinia-naive group

EXPERIMENTAL

2.5 \* 10\^5 pfu/dose

Drug: smallpox vaccine CJ-50300

Interventions

smallpox vaccine CJ-50300 DRUG

Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination

Also known as: CJ-53300

Vaccinia-naive group

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Korean male and female subjects between 19 and 60 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:

• Subjects who have been vaccinated with smallpox vaccines
• 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, basal cell carcinoma, liver cirrhosis or advanced liver disease).
• 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 who have taken corticosteroid within 3 months of vaccination or who are taking oral or parenteral corticosteroid.
• Subjects who have been taken immunosuppressive therapy including interferon within 3 months of vaccination or are taking immunosuppressive 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• HK inno.N Corporation: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Smallpox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Myoung-don Oh, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2010
• First Posted: January 26, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

KR (1)