drugset / Trial / NCT03663998

Optimising DNA Vaccinations in Healthy Volunteers

NCT03663998 ↗

RandomizedSequentialOpen-labelPrevention

Summary

This is a two part study to evaluate the immunogenicity and tolerability of DNA-C CN54ENV plasmid DNA (CN54ENV) administered with electroporation (EP), with and without DNA encoding recombinant interleukin-12 (GENEVAX® IL-12). Part 1 is exploratory and designed to select conditions capable of promoting enhanced B cell responses in a limited number of volunteers. Part 2 is dependent upon Part 1 and is designed to study the fine specificity of the B-cell immune responses to CN54ENV DNA in an expanded number of subjects. Data from both stages will be combined for safety and immunological analysis.

Timeline

Start
2015-08-15
Primary completion
2017-05-10
Completion
2018-04-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator CN54ENV DNA Unknown 400 ug Intramuscular
Comparator CN54ENV DNA Unknown 600 ug Intramuscular
Comparator CN54ENV DNA Unknown 1000 ug Intramuscular
Comparator CN54ENV DNA Unknown 1200 ug Intramuscular
Comparator CN54ENV DNA Unknown 1800 ug Intramuscular
Comparator CN54ENV DNA Unknown 4000 ug Intramuscular
Comparator GENEVAX® IL-12 DNA Unknown 500 ug Intramuscular
Comparator GENEVAX® IL-12 DNA Unknown 1500 ug Intramuscular