Smallpox Clinical Trial
Official title:
A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of LC16m8, A Modified Vaccinia Vaccine, in Healthy Volunteers
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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