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NCT01966224 · ClinicalTrials.gov registry record · Phase 1
A Safety and Immunogenicity Phase IB Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid Assessing the Long Term Safety of Previously Treated Subjects
A Phase 1 study, sponsored by Immunomic Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01966224 is a Phase 1 study that has completed, run by Immunomic Therapeutics. The registered enrollment target is 17 participants.
The verdict
NCT01966224, a Phase 1 study, has completed, sponsored by Immunomic Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This is a continuing research study of a vaccine for allergy to Japanese Red Cedar. The vaccine is called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the vaccine is tolerated and how previous Phase IA research participants respond to the vaccine in a booster dose. CryJ2-DNA-LAMP Plasmid vaccine is investigational, which means it is not approved for use by the United States Food and Drug Administration (FDA) but is available in research studies like this one. The study is a Phase IB, prospective, three cohort, open label study conducted on one cohorts of non-atopic subjects and two cohorts of subjects with a history of allergic rhinitis symptoms to Japanese red cedar CryJ 2 pollen allergen that participated in the previous Phase IA study (all the subjects participated in the previous study). The study will be conducted at 1 study center. Subjects are enrolled in the trial for a period of 80 days. The objectives of the statistical analyses are to establish the safety and to explore the immunogenicity of the LAMP-vax vaccine. All statistical analyses conducted on the data from this trial will be exploratory in nature. The primary objective of this Phase IB Study is to evaluate the safety and immunological responses of an additional dose of CryJ2-DNA-LAMP plasmid vaccine delivered intramuscularly (IM) to subjects who previously received 4 doses of CryJ2-DNA-LAMP vaccine delivered IM every 2 weeks in the previous Phase IA study.
Interventions
- BIOLOGICAL CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-09 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01966224
The ClinicalTrials.gov registry entry for NCT01966224 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immunomic Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection is the first listed.
NCT01966224 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01966224 about?
NCT01966224 is a clinical study titled "A Safety and Immunogenicity Phase IB Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid Assessing the Long Term Safety of Previously Treated Subjects". This is a continuing research study of a vaccine for allergy to Japanese Red Cedar. The vaccine is called CryJ2-DNA-LAMP Plasmid vaccine. This research study will determine how the vaccine is tolerated and how previous Phase IA research participants respond to the vaccine in a booster dose. CryJ2-DN...
What is the current status of trial NCT01966224?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2013-09. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01966224?
The interventions under investigation include: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT01966224?
This trial is sponsored by Immunomic Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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