Clinical Trials Logo
  1. Home
  2. Smallpox
  3. NCT01056770

Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers

Smallpox Clinical Trial

Official title:
An Open-label, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of CJ Smallpox Vaccine in Vaccinia-naive Healthy Volunteers

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01056770
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase Phase 3
Start date October 2009
Completion date January 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT05976100 - Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years Phase 1
Completed NCT01540929 - Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
Completed NCT00258947 - Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults Phase 2
Completed NCT00189969 - Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects Phase 1
Terminated NCT00053508 - Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination Phase 2
Completed NCT01317238 - Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers Phase 3
Withdrawn NCT00389103 - Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD) Phase 1
Completed NCT00998543 - A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain) Phase 2
Terminated NCT00282581 - Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive Phase 1
Completed NCT00133575 - ACAM 3000 MVA at Harvard Medical School Phase 1/Phase 2
Active, not recruiting NCT00103584 - Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers Phase 1/Phase 2
Completed NCT00050505 - Expanded Dryvax Dilution Study in Previously Vaccinated Adults Phase 2
Completed NCT05846243 - Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years Phase 2/Phase 3
Completed NCT05935917 - Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults Phase 1
Completed NCT00082446 - Combination Study With MVA BN and Dryvax Phase 1
Completed NCT00038987 - Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT Phase 1/Phase 2
Completed NCT05762523 - Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years Phase 1
Completed NCT04971109 - Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Day Phase 3
Completed NCT00646152 - Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study Phase 1
Completed NCT01668537 - A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects Phase 2