A Safety and Immunogenicity Phase IB Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid Assessing the Long Term Safety of Previously Treated Subjects
Condition: Allergic Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a continuing 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 previous Phase IA research participants respond to the vaccine
      in a booster dose. 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 IB, prospective, three cohort, open
      label study conducted on one cohorts of non-atopic subjects and two cohorts of subjects with
      a history of allergic rhinitis symptoms to Japanese red cedar CryJ 2 pollen allergen that
      participated in the previous Phase IA study (all the subjects participated in the previous
      study). The study will be conducted at 1 study center. Subjects are enrolled in the trial for
      a period of 80 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.

      The primary objective of this Phase IB Study is to evaluate the safety and immunological
      responses of an additional dose of CryJ2-DNA-LAMP plasmid vaccine delivered intramuscularly
      (IM) to subjects who previously received 4 doses of CryJ2-DNA-LAMP vaccine delivered IM every
      2 weeks in the previous Phase IA study.
    

Detailed description: 
      A further safety assessment of the JRC sensitive and non-sensitive subjects who were in Group
      1, 2 and 3 of the Phase 1A study will be further assessed in terms of current skin test
      reactivity, re-vaccination safety and continued safety.

      Group 1: will receive 2 mg CryJ2-DNA-LAMP plasmid vaccine by intramuscular (IM) injection.
      The dosing regimen for this group will be to receive one (1) booster dose. This group will be
      followed for 80 days (+/- 10), assessing skin reactivity and immune response.

      Group 2: will receive 2 mg CryJ2-DNA-LAMP plasmid vaccine by intramuscular (IM) injection.
      The dosing regimen for this group will be to receive one (1) booster dose. This group will be
      followed for 80 days (+/- 10), assessing skin reactivity and immune response.

      Group 3: will receive 2 mg CryJ2-DNA-LAMP plasmid vaccine by intramuscular (IM) injection.
      The dosing regimen for this group will be to receive one (1) booster dose. This group will be
      followed for 80 days (+/- 10), assessing skin reactivity and immune response.
    

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 the groups will be to receive one re-vaccination dose.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment