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NCT02348320 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT02348320: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT02348320 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02348320, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a phase 1 open-label study to evaluate the safety and immunogenicity of a personalized polyepitope DNA vaccine strategy. The personalized polyepitope DNA vaccines will be formulated as naked plasmid DNA vaccines. The hypothesis of this study is that personalized polyepitope DNA vaccines will be safe for human administration and capable of generating measurable CD8 T cell responses to mutant tumor-specific antigens.
Primary Outcome
Assessment of plasmid DNA safety will include both clinical observation and laboratory evaluation. Safety will be closely monitored after injection with eight or more clinical and laboratory assessments in the first 24 weeks of the trial. The following parameters will be assessed following vaccination: 1. Local signs and symptoms 2. Systemic signs and symptoms 3. Laboratory evaluations, including blood counts and serum chemistries 4. Adverse, and serious adverse events
Interventions
- BIOLOGICAL Personalized polyepitope DNA vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-06-17 |
| Est. Completion | 2020-03-12 |
| Phase | Phase 1 |
What the finished NCT02348320 record still lists
NCT02348320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which Personalized polyepitope DNA vaccine is the first listed.
NCT02348320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02348320 about?
NCT02348320 is a clinical study titled "Safety and Immunogenicity of a Personalized Polyepitope DNA Vaccine Strategy in Breast Cancer Patients With Persistent Triple-Negative Disease Following Neoadjuvant Chemotherapy". This is a phase 1 open-label study to evaluate the safety and immunogenicity of a personalized polyepitope DNA vaccine strategy. The personalized polyepitope DNA vaccines will be formulated as naked plasmid DNA vaccines. The hypothesis of this study is that personalized polyepitope DNA vaccines will...
What is the current status of trial NCT02348320?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-06-17. Estimated completion is 2020-03-12.
What interventions are being tested in trial NCT02348320?
The interventions under investigation include: Personalized polyepitope DNA vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02348320?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02348320's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 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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