drugset / Trial / NCT00471133

Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation

NCT00471133 ↗

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine encoding a melanosomal antigen in melanoma patients at risk for disease progression or recurrence. In this study, the vaccine will be administered intramuscularly using a device that applies brief electrical fields to the tissue at the site of injection (a technique known as electroporation). It is expected that this device will improve the delivery of the vaccine. This study is being performed to determine if this procedure can be administered safely and if it is capable of inducing immune responses to the vaccine.

Timeline

Start
2007-04
Primary completion
2010-05
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject pINGmuTyr Vaccine 0.2 mg Intramuscular
Subject pINGmuTyr Vaccine 0.5 mg Intramuscular
Subject pINGmuTyr Vaccine 1.5 mg Intramuscular