drugset / Trial / NCT03663998
Optimising DNA Vaccinations in Healthy Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |