drugset / Trial / NCT02589795
Safety and Immunogenicity of HIV DNA-C CN54ENV and Recombinant HIV CN54gp140 Vaccines in Healthy Volunteers
RandomizedParallel-groupOpen-labelOther
Summary
CUTHIVAC002 is a randomised Phase I study aimed at exploring the safety and immunogenicity of two different modes of delivery of a deoxyribonucleic acid (DNA) vaccine (DNA-C CN54ENV) via combined intramuscular and intradermal methods with and without electroporation, and boosted with recombinant HIV CN54gp140 administered by intradermal injection in healthy volunteers. The aim of this study is to identify optimal DNA delivery conditions for promoting enhanced antibody responses to boosting with recombinant protein by the intradermal method.
Timeline
- Start
- 2016-08-11
- Primary completion
- 2017-12-22
- Completion
- 2017-12-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CN54gp140 | Vaccine | 50 ug | Intramuscular |
| Subject | DNA-C CN54ENV | Vaccine | 0.6 mg | Intramuscular |
| Subject | DNA-C CN54ENV | Vaccine | 2 mg | Intramuscular |