drugset / Trial / NCT01127464

DCVax Plus Poly ICLC in Healthy Volunteers

NCT01127464

Phase 1 Completed 43 enrolled Rockefeller University
RandomizedParallel-groupDouble-blindBasic science

Summary

DCVax-001 is a recombinant protein vaccine designed to prevent and potentially treat human immunodeficiency virus (HIV) infection. The vaccine is composed of a fusion protein containing a human monoclonal antibody specific for the dendritic cell receptor, DEC-205 (CD205), and the HIV gag p24 protein. The vaccine is designed to target HIV antigens directly to endocytic pathways in dendritic cells (DCs) that allow for efficient processing and presentation of multiple HIV peptides on both MHC class I and II products, which will induce HIV-specific CD8+ and CD4+ T cells. This vaccine candidate must be combined with appropriate immunostimulants (adjuvants) to induce immunity to the antigen. In the proposed clinical trial we will use poly ICLC (Hiltonol) from Oncovir, Inc as the adjuvant.

Timeline

Start
2010-05
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject DCVax-001 Vaccine 0.3 unknown
Subject DCVax-001 Vaccine 1 mg
Subject DCVax-001 Vaccine 3 mg
Subject Hiltonol Other / unclassified 1.6 ml
Subject Hiltonol Other / unclassified 1.6 mg