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
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
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 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.
    

Detailed description: 
      A safety and Immunological assessment of JRC sensitive (atopic) subjects will be assessed in
      terms of current skin test reactivity. 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 to one of 3 study vaccine cohorts:

      Cohort 1: These Japanese Red Cedar atopic and non-atopic subjects will be recruited as a
      placebo control. This cohort will be composed of 5 atopic and 5 non-atopic subjects (half of
      the subjects will be atopic and half non-atopic), that will receive 4 vaccinations, 14 days
      apart, of a saline control in four separate 0.200 ml volumes administered Intradermally (ID)
      using the needle-free Biojector device.

      Cohort 2: These Japanese Red Cedar atopic subjects will receive intradermal (ID) injections
      of the same CryJ2-DNA-LAMP vaccine previously used in Phase IA and IB studies. Cohort #2 will
      receive four (4) 2.16 mg doses at 14 day intervals. Each 2.16 mg dose will require
      administration of four (4) separate 0.200 ml volumes of a 2.7 mg/ml vaccine concentrate using
      the needle-free Biojector device. Each of the four volumes will be injected at different
      sites on the same or different deltoid muscle.

      Cohort 3: These Japanese Red Cedar atopic subjects will receive intradermal (ID) injections
      of the same CryJ2-DNA-LAMP vaccine previously used in Phase IA and IB studies. Cohort #3 will
      receive four (4) 1.08 mg doses at 14 day intervals. Each 1.08 mg dose will require
      administration of two (2) separate 0.200 ml volumes of a 2.7 mg/ml vaccine concentrate using
      the needle-free Biojector device. Each of the four volumes will be injected at different
      sites on the same or different deltoid muscle.

      There will be between 18 to 26 men and women participating in the study at one location. Your
      participation in this study will last approximately 132 days.
    

Intervention name(s): CryJ2-DNA-LAMP plasmid vaccine by intradermal injection; Saline Control
Intervention type(s): Biological; Other
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 intradermal injection using the Biojector 2000 devibe.; The subjects in Cohort 1 will receive four doses of saline control 14 days apart, beginning Day 0. Each dose will be delivered as four separate injections of 0.200 mL volumes administered Intradermally (ID) using the needless Biojector 2000 device in separate skin sites. The use of the four 0.200 mL volumes is necessitated in order to compare the skin test sites to the number of sites in Cohorts 2 (4 sites per dose) and Cohort 3 (2 sites per dose). The multiple intradermal administration sites per dose are because of the dilute vaccine material (2.7 mg/mL).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment