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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
NCT02146781 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Immunomic Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02146781 reports 1 study location spanning 1 distinct geographic area — top geographies include Hawaii. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02146781?
This trial is sponsored by Immunomic Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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