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COMPLETEDPHASE1

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

NCT01966224•Immunomic Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 63 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects that participated in the previous Phase I A study who demonstrated a change from positive to Japanese Red Cedar pollen/Mountain Cedar at Day 0, to negative in at Day 132 (to be assigned to Group 1) and who have not experienced a grade 3 adverse reaction.
•Subjects that participated in the previous Phase I A study who originally tested negative and remained negative to Japanese Red Cedar pollen/Mountain Cedar negative from Day 0 through Day 132 (to be assigned to Group 2 ) and who have not experienced a grade 3 adverse reaction.
•Execute a written informed consent (in English and where appropriate in Japanese) to participate in the study.
•Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception for the duration of the study: hormonal (oral, implant, or injection) begun \>30 days prior to screening, barrier (condom, diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum).
•No clinically significant abnormal findings on the physical examination, with the exception of HEENT (head, eyes, ears, nose and throat) findings consistent with allergic rhinitis, medical history, or clinical laboratory results during screening which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
•Subject must be willing and able to comply with study requirements.

Exclusion Criteria

•History of anaphylaxis requiring medical intervention.
•Intolerance of or severe allergic reaction to previous immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide).
•History of asthma requiring daily medication with the exception of exercise induced asthma. (History of intermittent and/or mild asthma is permitted)
•Subjects receiving anti-IgE monoclonal antibodies, or any antibodies therapeutically.
•Congenital immune deficiency or acquired immune suppression. Causes of acquired immune suppression may include, but are not limited to, systemic illnesses such as malignancy and infection, the use of medications such as corticosteroids and chemotherapeutic agents, and radiation therapy.
•History of organ transplant, hematologic malignancy, autoimmune disease, myocardial infarction, or congestive heart failure.
•History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic diseases which, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
•Inability or unwillingness to stop using drugs that may inhibit the ability to treat a severe allergic adverse event. This includes, but is not limited to; beta blockers such as atenolol (Tenormin), metoprolol (Lopressor, Toprol-XL) and propranolol (Inderal, Inderal LA) for 48 hours prior to each visit. All subjects must be off of antihistamine therapy 7 days before skin testing.
•Female subjects who are trying to conceive, are pregnant, or are lactating.
•Positive serum pregnancy test at screening or a positive human chorionic gonadotropin (HCG) urine test on Visit 1 for women of childbearing potential.
+7 more criteria

Locations (1)

East West Medical Research Institute

Honolulu, Hawaii, United States

Key Dates

Start Date

September 1, 2013

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2013

Last Updated

April 30, 2014

Enrollment

ACTUAL participants

Conditions

Allergic Rhinoconjunctivitis

Interventions

CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study

Study of BLU-808 in Allergic Rhinoconjunctivitis

Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction

Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

Efficacy and Safety of Norketotifen in Adults With Allergic Rhinitis

Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy