Safety and Efficacy of CJ-50300 in Healthy Volunteers

NCT00607243 | Completed Phase 2 Results DMC

• 2 other identifiers: CJ_SPX_301CJ corporation
• Study Type: interventional
• Target: 123
• 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)

• Cutaneous Take Reaction

  The "take reaction"was defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6-8. The vaccination site was photographed, and measures were taken.

  7-9 day

• Adverse Reactions

  0-28 days

Secondary Outcomes (2)

• Antibody Response

  14 or 28 days

• Cell-mediate Immunity

  14 or 28 days

Study Arms (2)

Conventional dose group

EXPERIMENTAL

Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination

Biological: smallpox vaccine CJ-50300

Low dose group

EXPERIMENTAL

Diluted CJ-50300 2.5 x 10000pfu/dose vaccination

Biological: smallpox vaccine CJ-50300

Interventions

smallpox vaccine CJ-50300 BIOLOGICAL

Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose

Also known as: CJ-53300

Conventional dose group; Low dose group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Korean male and female subjects between 20 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
• Subjects who have never been vaccinated with smallpox vaccines

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 requiring steroid therapy
• Subjects who 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
• Receipt of immunoglobulin and steroid within 14 days of vaccination

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

Related Publications (1)

• 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. 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. Vaccine. 2010 Aug 16;28(36):5845-9. doi: 10.1016/j.vaccine.2010.06.063. Epub 2010 Jun 30.

  PMID: 20600480 DERIVED

MeSH Terms

Conditions

Smallpox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

the study was limited to vaccinia-naïve adults, thus yielding no data concerning the efficacy of CJ-50300 in non-naïve adults or in children.

Results Point of Contact

• Title: Myoung-don Oh, M.D.
• Organization: Seoul National University Hospital

mdohmd@snu.ac.kr

+82-2-2072-2945

Study Officials

• Myoung-don Oh, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Infectious Diseases, Department of Internal Medicine

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 5, 2008
• Study Start: January 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 9, 2013
• Results First Posted: July 9, 2013

Record last verified: 2013-07

Locations

KR (1)