Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT01707069
Brief 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 in various doses. 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. This is the first time that CryJ2-DNA-LAMP Plasmid vaccine is being given to humans.
The purpose of this study is to evaluate the safety of an investigational vaccine intended to treat allergy to Japanese red cedar. The vaccine is composed of DNA, which is the material that cells use to provide instructions to make proteins. The DNA carries the information necessary to make a special protein which is a combination of a protein found in all cells, LAMP (lysosomal associated membrane protein), and the protein from Japanese red cedar that causes the allergy known as Cry J2. This vaccine is intended to help re-educate the immune system with respect to how it will respond to naturally occurring red cedar allergen and eliminate the allergic symptoms. Another purpose of this study will be to document the immune response to the vaccine
Subjects that are eligible to participate in this study will be assigned by whether they are sensitive or non sensitive to CryJ2 or Mountain Cedar and chance (like flipping a coin) to one of 3 study vaccine groups:
Group 1: will receive four (4) 4-milligram doses of the study vaccine. Group 2: will receive four (4) 2-milligram doses of the study vaccine. Group 3: will receive four (4) 4-milligram doses of the study vaccine.
The study vaccine is administered as an intramuscular injection. Enrolled subjects will receive the study vaccine every 14 days (at day 0, 14, 28 and 42). Subjects will know their study vaccine assignment. Participants who are not allergic to Japanese red cedar will be assigned to Group 1. Participants who do have an allergy to Japanese red cedar or Mountain Cedar will have an equal chance of being assigned to Group 2 or 3.
There will be between 18 to 30 men and women participating in the study at one location. Your participation in this study will last approximately 72 days.
Detailed Description:
The study is a Phase I, prospective, three cohort, open label study conducted on one cohort of non-atopic subjects and two cohorts of patients with a history of allergic rhinitis symptoms to Japanese red cedar Cry j 2 pollen allergen. The study will be conducted at 1 study center. Subjects are enrolled in the trial for a period of 72 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.
Study:
NCT01707069
Study Brief:
Protocol Section:
NCT01707069