drugset / Trial / NCT02589795

Safety and Immunogenicity of HIV DNA-C CN54ENV and Recombinant HIV CN54gp140 Vaccines in Healthy Volunteers

NCT02589795

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

EvaluationDrugModalityDoseRoute
Subject CN54gp140 Vaccine 50 ug Intramuscular
Subject DNA-C CN54ENV Vaccine 0.6 mg Intramuscular
Subject DNA-C CN54ENV Vaccine 2 mg Intramuscular