Healthy male and female subjects 18 to 63 years of age, who have lived in Japan and are skin test positive or negative at Screening to Japanese Red Cedar, Mountain Cedar and/or CryJ2 allergens.
Cohort # 1: Subjects will receive four 0.200 mL volume intradermal injections of saline control as a placebo control using the Biojector device.
Intervention: Saline Control via Intradermal route.

Healthy male and female subjects 18 to 63 years of age who have lived in Japan and are skin test positive at Screening to Japanese Red Cedar, Mountain Cedar and/or CryJ2 allergens and have a history of allergic rhinitis symptoms during the Japanese Red Cedar or Mountain cedar pollen seasons.
Cohort # 2: Subjects receive four (4) injections of 0.200 mL volumes (2.7 mg/mL) for a single dose of 2.16 mg of CryJ2-DNA-LAMP plasmid vaccine; intradermally (ID) administered using the Biojector device (each dose administered by separate Biojector device injections at different skin sites. These subjects will receive the same batch vaccine used in Phase 1A and 1B
Intervention: Biological/Vaccine: CryJ2-DNA-LAMP plasmid vaccine by intradermal injection

Healthy male and female subjects 18 to 63 years of age who have lived in Japan and are skin test positive at Screening to Japanese Red Cedar, Mountain Cedar and/or CryJ2 allergens and have a history of allergic rhinitis symptoms during the Japanese Red Cedar or Mountain cedar pollen seasons.
Cohort # 3: Subjects will receive two (2) injections of 0.200 mL (2.7 mg/mL) for a single dose intradermally (ID) for a single dose of 1.08 mg CryJ2-DNA-LAMP plasmid vaccine administered using the Biojector device, each dose administered by separate Biojector device injections at different skin sites. These subjects will receive the same batch vaccine used in Phase 1A and 1B
Intervention: Biological/Vaccine: CryJ2-DNA-LAMP plasmid vaccine by intradermal injection

Allergic Rhinitis

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.

CryJ2-DNA-LAMP plasmid vaccine by intradermal injection

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).

Saline Control

East West Medical Research Institute

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

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

The primary objective of this Phase IC Study is to evaluate the safety of the therapeutic doses and the dosing regimen of CryJ2-DNA-LAMP plasmid vaccine delivered intradermally (ID) using the Biojector 2000 device.
AEs will be monitored at days 14, 28, 42, 72, 102 & 132/ET

Immonogenecity parameters include: Japanese Red Cedar Immunocap (IgE & IgG), Mountain Cedar Immunocap (IgE) & Th1/Th2 cytokines ELISA Panel.
These parameters will determine if there is a change in beneficial immunoglobulins(IgG), and changes in Th1/Th2 cytokines in the serum of non-atopic (no allergic sensitivities to CryJ2 allergen) subjects and atopic subjects with known allergy to Japanese Red Cedar CryJ2 allergen. These subjects were identified by positive skin test re-activity and/or IgG specific antibody titers from previous time-points in the Phase IA using one boost of IM route of administration.
Immunogenicity parameters will be measured at baseline and days 0, 14, 28, 42, 72, 102 & 132/ET

Immunomic Therapeutics, Inc.

Healthy male and female subjects 18 to 63 years of age that participated in the previous Phase 1A study, from Group 1, who were skin test negative at Day 0 and remained negative at Day 132.
Group 1: These subjects will be re-vaccinated with one dose of 2mg Biological/Vaccine: CryJ2-DNA-LAMP plasmid vaccine administered by Intramuscular injection (IM) approximately 200-250 days after the last of the 4 vaccinations administered under the Phase IA study. These subjects will receive the same batch vaccine used in Phase 1A.

Healthy male and female subjects 18 to 63 years of age that participated in the previous Phase 1A study, from Group 2, who were skin test positive at Day 0 and remained positive or converted to negative for any JRC-related allergens at Day 132.
Group 2: These subjects will be re-vaccinated with one dose of 2mg Biological/Vaccine: CryJ2-DNA-LAMP plasmid vaccine administered Intramuscularly (IM) approximately 200-250 days after the last of the 4 vaccinations administered under the Phase IA study. These subjects will receive the same batch vaccine used in Phase 1A.

Healthy male and female subjects 18 to 63 years of age that participated in the previous Phase 1A study, from Group 3, who were skin test positive at Day 0 and remained positive or converted to negative for any JRC-related allergens at Day 132.
Group 3: These subjects will be re-vaccinated with one dose 2mg of Biological/Vaccine: CryJ2-DNA-LAMP plasmid vaccine administered Intramuscularly (IM) approximately 200-250 days after the last of the 4 vaccinations administered under the Phase IA study.

Allergic Rhinoconjunctivitis

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.

CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

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

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 CryJ2-DNA-LAMP Vaccinated Subjects and the Safety of a Booster Vaccination

The primary objective of this Phase I Study is to evaluate the safety and immunological responses of therapeutic doses and the dosing regimen of CryJ2-DNA-LAMP plasmid vaccine.
Adverse events will be monitored on each subject from the time of enrollment to exit from the study. Vital signs will be recorded on each subject at baseline and days 50, 80 and early termination. Physical exams will be conducted on the subjects at the baseline and days 50, 80 and early termination.

Immonogenecity parameters include: Japanese Red Cedar Immunocap (IgE & IgG), Mountain Cedar Immunocap (IgE) & Th1/Th2 cytokines ELISA Panel.
These parameters will determine if there is a change in beneficial immunoglobulins(IgG), and changes in Th1/Th2 cytokines in the serum of non-atopic (no allergic sensitivities to CryJ2 allergen) subjects and atopic subjects with known allergy to Japanese Red Cedar CryJ2 allergen. These subjects were identified by positive skin test re-activity and/or IgG specific antibody titers from previous time-points in the Phase IA using one boost of IM route of administration.
Immunogenicity parameters will be measured at baseline and days 50, 80 or ET of the trial.

Healthy male and female subjects 18 to 63 years of age, who are skin test negative to Japanese Red Cedar pollen or Mountain Cedar pollen and have no reactive Cry J 2 antibodies.
Group 1: will receive 4mg of Biological/Vaccine: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection (considered to be the optimal DNA vaccine dose based on historical clinical data from other DNA vaccine studies). The dosing regimen for this group will be to receive three (3) additional booster doses (4 doses in total) of a 4 mg dose at 14 day intervals.

Healthy male and female subjects 18 to 63 years of age, who have lived in Japan, are Skin test positive to Japanese Red Cedar pollen or Mountain Cedar pollen and/or have reactive Cry J 2 antibodies, and have a history of allergic rhinitis symptoms during the Japanese Red Cedar or Mountain Cedar season will receive a total of four half (2 mg) dose dosing regimen.
Group 2: will receive 2 mg Biological/Vaccine: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection(considered ½ of the optimal plasmid vaccine dose based on historical clinical data from studies with other antigens). The dosing regimen for this group will be to receive three (3) additional 2 mg doses at 14 day intervals between doses (4 doses in total).

Healthy male and female subjects 18 to 63 years of age, who have lived in Japan, are Skin test positive to Japanese Red Cedar pollen or Mountain Cedar pollen and/or have reactive Cry J 2 antibodies, and have a history of allergic rhinitis symptoms during the Japanese Red Cedar or Mountain Cedar season will receive a total of four full (4 mg) dose dosing regimen.
Group 3: will receive 4 mg Biological/Vaccine: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection (considered the optimal plasmid vaccine dose based on historical clinical data from studies with other antigens). The dosing regimen for this group will be to receive 3 additional 4 mg doses at 14 day intervals between doses (4 doses in total).

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.

A Safety and Immunogenicity Phase I Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid

The primary objective of this Phase I Study is to evaluate the safety and immunological responses of therapeutic doses and the dosing regimen of CryJ2-DNA-LAMP plasmid vaccine.
Adverse events will be monitored on each subject from the time of enrollment to exit from the study. Vital signs will be recorded on each subject at baseline and days 14, 28, 42 and 72. Clinical laboratory parameters will be obtained from blood samples taken at the baseline and final time points. Physical exams will be conducted on the subjects at the baseline and final time points.

Immunogenicity parameters will be measured at baseline and days 14, 28, 42 and 72 or ET of the trial.

juniperus virginiana/hypersensitivity

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

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

A Safety and Immunogenicity Phase I Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid

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