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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00103584
Other study ID # VAX012
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received February 10, 2005
Last updated January 11, 2007
Start date October 2004
Est. completion date July 2006

Study information

Verified date January 2007
Source VaxGen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is a Phase I/II study evaluating the safety and immunogenicity of LC16m8, a modified vaccinia vaccine. After consent and thorough screening (including safety labs, EKG, and medical history), healthy, previously unvaccinated volunteers between the ages of 18-34 will receive a single vaccination of either LC16m8 or the current US-licensed smallpox vaccine, Dryvax. Volunteers will be blindly randomized to a treatment group in a 4:1 ratio (4 LC16m8 to 1 Dryvax recipient). Follow-up clinical evaluations, laboratory testing, EKGs and cardiac assessments will be done at regularly scheduled follow-up visits for 1 year after vaccination.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
LC16m8 Smallpox Vaccine


Locations

Country Name City State
United States University of Kentucky, Kentucky Clinic Lexington Kentucky
United States Vanderbilt University Medical Center, General Clinical Research Center Nashville Tennessee
United States St. Louis University, Center for Vaccine Development St. Louis Missouri
United States Stanford University, General Clinical Research Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
VaxGen

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and immunogenicity
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