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NCT01127464 · ClinicalTrials.gov registry record · Phase 1
DCVax Plus Poly ICLC in Healthy Volunteers
A Phase 1 study, sponsored by Rockefeller University.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01127464: Completed Phase 1 study, sponsored by Rockefeller University.
NCT01127464 is a Phase 1 study that has completed, run by Rockefeller University. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01127464, a Phase 1 study, has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
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.
Primary Outcome
The proportion of volunteers with moderate local reactogenicity events; Proportion of volunteers with moderate systemic reactogenicity events; Proportion of volunteers with other moderate adverse events; Proportion of volunteers with serious adverse events; Proportion of volunteers with severe and moderate local and systemic reactogenicity events and adverse events.
Interventions
- DRUG Placebo
- DRUG Poly-ICLC
- DRUG DCVax-001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
What the finished NCT01127464 record still lists
NCT01127464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01127464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01127464 about?
NCT01127464 is a clinical study titled "DCVax Plus Poly ICLC in 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...
What is the current status of trial NCT01127464?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2010-05. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01127464?
The interventions under investigation include: Placebo (DRUG), Poly-ICLC (DRUG), DCVax-001 (DRUG).
Who is sponsoring clinical trial NCT01127464?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01127464's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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