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NCT01012700 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers
A Phase 1 study, sponsored by Rockefeller University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01012700: Completed Phase 1 study, sponsored by Rockefeller University.
NCT01012700 is a Phase 1 study that has completed, run by Rockefeller University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01012700, a Phase 1 study, has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Vaccines induce protective immunity against numerous infectious diseases. However, current vaccines have limited efficacy against challenging infections like tuberculosis, malaria and HIV. Protein vaccines are safe but, typically, they induce weak T cell immunity when administered alone. Therefore, special attention is being given to adjuvants, which are enhancers of immunity, that mature antigen presenting immunostimulatory dendritic cells (DCs). Our goal is to study in humans the mechanism whereby synthetic adjuvants, acting on defined pattern recognition receptors (PRR), enhance T and B cell immunity. In preclinical studies, the investigators' laboratory has found in mice that poly IC and its analog poly ICLC are superior adjuvants for T cell mediated immunity relative to other agonists for PRR. In this study the investigators propose to study the safety and the innate immune responses to poly ICLC in multiple blood cell types, including three different subsets of DCs when administered subcutaneously or intranasally to healthy volunteers. Poly ICLC is a stabilized double stranded RNA which has been extensively studied in humans with a favorable safety profile.
Interventions
- DRUG Hiltonol (poly ICLC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
What the finished NCT01012700 record still lists
NCT01012700 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Hiltonol (poly ICLC) is the first listed.
NCT01012700 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01012700 about?
NCT01012700 is a clinical study titled "Study to Evaluate the Safety and Immunogenicity of Poly ICLC (Hiltonol) in Healthy Volunteers". Vaccines induce protective immunity against numerous infectious diseases. However, current vaccines have limited efficacy against challenging infections like tuberculosis, malaria and HIV. Protein vaccines are safe but, typically, they induce weak T cell immunity when administered alone. Therefore, ...
What is the current status of trial NCT01012700?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-11. Estimated completion is 2010-04.
What interventions are being tested in trial NCT01012700?
The interventions under investigation include: Hiltonol (poly ICLC) (DRUG).
Who is sponsoring clinical trial NCT01012700?
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 NCT01012700's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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