NCT00103584

Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers

A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of LC16m8, A Modified Vaccinia Vaccine, in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: VaxGen · Industry
• Sex: All
• Age: 18 Years – 34 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	LC16m8 Smallpox Vaccine

Timeline

• Start date: 2004-10-01
• Completion: 2006-07-01
• First posted: 2005-02-11
• Last updated: 2007-01-15

Locations

4 sites across 1 country: United States