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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 is a Phase 1 study that has completed, run by Rockefeller University. The registered enrollment target is 24 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01012700
The ClinicalTrials.gov registry entry for NCT01012700 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hiltonol (poly ICLC) is the first listed.
NCT01012700 reports 0 study locations.
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.
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