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
Public ClinicalTrials.gov record NCT02146781. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Safety and Immunogenicity Phase IC Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid for Assessment of Intradermal (ID) Route of Administration Using the Biojector 2000 Device
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 the Biojector 2000 device.
Study identification
- NCT ID
- NCT02146781
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 22 participants
Conditions and interventions
Conditions
Interventions
- CryJ2-DNA-LAMP plasmid vaccine by intradermal injection Biological
- Saline Control Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years to 63 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2014
- Primary completion
- Feb 28, 2015
- Completion
- Feb 28, 2015
- Last update posted
- Mar 24, 2015
2014 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| East West Medical Research Institute | Honolulu | Hawaii | 96814 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02146781, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2015 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02146781 live on ClinicalTrials.gov.