A Safety and Immunogenicity Phase I Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid
Condition: Allergic Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection
Intervention type(s): Biological
Intervention description(s): Immunomic Therapeutics Inc. CryJ2-DNA-LAMP vaccine is a frozen product formulated in physiological saline and contains no preservative. The study product is packaged in a 1 ml volume in a 3 ml glass vial, with label complying with FDA requirements.
Subjects will receive CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection. The dosing regimen for this group will be to receive three (3) additional booster doses (4 doses in total) at 14 day intervals.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment