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NCT02146781 · ClinicalTrials.gov registry record · Phase 1
A Safety and Immunogenicity Phase IC Study of CryJ2 -DNA-LAMP Plasmid Vaccine for Assessment of Intradermal (ID) Route of Administration Using the Biojector 2000 Device
A Phase 1 study of Allergic Rhinitis, sponsored by Immunomic Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT02146781 is a Phase 1 study of Allergic Rhinitis that has completed, run by Immunomic Therapeutics. The registered enrollment target is 22 participants, below the 104-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02146781, a Phase 1 study of Allergic Rhinitis, has completed, sponsored by Immunomic Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a 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 research participants respond to the vaccine using a different route of administration, the Intradermal (ID) route. 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 IC study to assess and evaluate the safety and immunological responses to therapeutic doses of a dosing regimen of 1.08 mg and 2.16 mg of CryJ2-DNA-LAMP plasmid vaccine delivered intradermally (ID) using the Biojector 2000 device, to be administered every 14 days in subjects with atopic sensitivity to Japanese Red Cedar pollen, identified by skin test reactivity to this pollen. The protocol has three subject cohorts: a Cohort 1: composed of atopic and non-atopic subjects (half atopic and half non-atopic), who will only receive saline control administered using the Biojector 2000 device; a Cohort 2: atopic subjects, who will receive 2.16 mg per dose in a four (4) dose regimen using a Biojector 2000 device; and a Cohort 3: atopic subjects, who will receive 1.08 mg per dose in a four (4) dose regimen vaccinated using a Biojector 2000 device.The study will be conducted at 1 study center. Subjects are enrolled in the trial for a period of 132 days. The objectives of the statistical analyses are to establish the safety and to explore the immunogenicity of the LAMP-vax vaccine using a different route of administration, the Intradermal (ID) route. All statistical analyses conducted on the data from this trial will be exploratory in nature. The primary objective of this Phase IC Study is to evaluate the safety and immunological responses of therapeutic doses and the dosing regimen of CryJ2-DNA-LAMP plasmid vaccine delivered intradermally (ID) using
Conditions Studied
Interventions
- OTHER Saline Control
- BIOLOGICAL CryJ2-DNA-LAMP plasmid vaccine by intradermal injection
Study Locations (1)
Hawaii
- East West Medical Research Institute - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02146781
The ClinicalTrials.gov registry entry for NCT02146781 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 23 other Allergic Rhinitis trials with a reported enrollment target (79% lower). The listed sponsor is Immunomic Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Allergic Rhinitis appearing as the primary indexed condition, and to 2 interventions - of which Saline Control is the first listed.
NCT02146781 reports 1 study location spanning 1 distinct geographic area - top geographies include Hawaii.
Frequently Asked Questions
What is clinical trial NCT02146781 about?
NCT02146781 is a clinical study titled "A Safety and Immunogenicity Phase IC Study of CryJ2 -DNA-LAMP Plasmid Vaccine for Assessment of Intradermal (ID) Route of Administration Using the Biojector 2000 Device". This is a 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 research participants respond to the vaccine using a different route of administration, the Intraderm...
What is the current status of trial NCT02146781?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2014-06. Estimated completion is 2015-03.
What conditions does trial NCT02146781 study?
This clinical trial studies the following conditions: Allergic Rhinitis.
What interventions are being tested in trial NCT02146781?
The interventions under investigation include: Saline Control (OTHER), CryJ2-DNA-LAMP plasmid vaccine by intradermal injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT02146781?
This trial is sponsored by Immunomic Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02146781 being conducted?
This trial has 1 study location across Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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