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DCVax Plus Poly ICLC in Healthy Volunteers

NCT01127464 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2014-05-08

No results posted yet for this study

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.

Conditions

  • HIV-1 Infection
  • HIV Infection
  • Healthy Volunteers

Interventions

DRUG

DCVax-001

Comparison of 3 different doses of DCVax-001 administered with poly-ICLC, the administration of poly-ICLC alone, or a placebo control

DRUG

Poly-ICLC

Comparison of 3 different doses of DCVax-001 administered with poly-ICLC, the administration of poly-ICLC alone, or a placebo control

DRUG

Placebo

Comparison of 3 different doses of DCVax-001 administered with poly-ICLC, the administration of poly-ICLC alone, or a placebo control

Sponsors & Collaborators

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Sarah Schlesinger, MD · The Rockefeller University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01127464 on ClinicalTrials.gov