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NCT02362464 · ClinicalTrials.gov registry record · Phase 2
Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT02362464: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02362464 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02362464, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Background: \- Few studies or literature are available about the long-term safety of repeated peptide vaccinations in people over a period of time. Long-term vaccination may be needed to control tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now they want to give those same men the new version of the vaccine. They want to see if it produces different types of immune responses and also ensure that repeated vaccinations are safe. Objectives: \- To find out the long-term safety of repeated T-cell receptor alternate reading frame protein (TARP) peptide vaccinations. Eligibility: \- Men who took part in National Cancer Institute (NCI) protocol 09-C-0139. Design: * Participants will be screened with blood tests, scans, physical exam, medical history, and an evaluation of how well they perform everyday activities. * Participants will have apheresis. Blood will be removed with a needle from one arm. A machine will separate the white blood cells. The blood, minus the white cells, will be returned through a needle in the other arm. * Participants will have 14 visits. At each visit, they will have a physical exam and blood tests. They will discuss any side effects. * Participants will get vaccine injections at weeks 3, 6, 9, 12, 15, and 24. The vaccine will be made from the participants own cells. * Participants will get a Vaccine Report Card to complete after receiving vaccine. * The study lasts 96 weeks.
Primary Outcome
The number of Grade 3 adverse events probably related to the vaccine treatment. Adverse events were measured using the Common Terminology Criteria for Adverse Events (CTCAE v.4.0). Grade 3 is severe.
Interventions
- BIOLOGICAL Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-05-12 |
| Est. Completion | 2022-03-25 |
| Phase | Phase 2 |
What the finished NCT02362464 record still lists
NCT02362464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine is the first listed.
NCT02362464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02362464 about?
NCT02362464 is a clinical study titled "Long-Term TARP Vaccination Using a Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Previously Vaccinated Men on NCI 09-C-0139". Background: \- Few studies or literature are available about the long-term safety of repeated peptide vaccinations in people over a period of time. Long-term vaccination may be needed to control tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now they want to gi...
What is the current status of trial NCT02362464?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2015-05-12. Estimated completion is 2022-03-25.
What interventions are being tested in trial NCT02362464?
The interventions under investigation include: Multi-epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02362464?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02362464's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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