DCVax Plus Poly ICLC in Healthy Volunteers
| Status: | Archived |
|---|---|
| Conditions: | Healthy Studies, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | May 2010 |
| End Date: | May 2013 |
A Randomized, Placebo-controlled, Dose-escalating, Double-blinded Phase I Study to Evaluate the Safety and Immunogenicity of Anti-DEC-205 Monoclonal Antibody (Mab) Targeted HIV Gag p24 Vaccine (DCVax-001) With Poly ICLC (Hiltonol) as Adjuvant in HIV-uninfected Healthy Volunteers
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.
This trial will investigate whether delivery of HIV antigens via immunization with
anti-DEC-205 p24 monoclonal antibody plus poly ICLC, as an adjuvant, is safe and induces
either cellular or humoral immunogenicity in healthy volunteers. We propose to assess the
quality of immunity elicited by DEC targeted vaccines in humans. Immunogenicity after HIV
antigen delivery directly to dendritic cells could provide the proof-of-concept that
dendritic cell targeted protein vaccines may serve as a stand-alone vaccine strategy or in
combination with other vaccine modalities against HIV or other diseases.
The main hypothesis of this study is to assess the delivery of HIV antigens via immunization
with anti-DEC-205 p24 monoclonal antibody (DCVax-001) plus poly ICLC (Hiltonol) is safe and
induces either cellular or humoral immunogenicity in HIV-uninfected, healthy volunteers.
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