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

NCT ID: NCT01966224

Last Updated: 2014-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2mg CryJ2-DNA-LAMP plasmid vaccine Group 1

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.

Group Type: EXPERIMENTAL

CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

Intervention Type: BIOLOGICAL

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.

2mg CryJ2-DNA-LAMP plasmid vaccine Group 2

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.

Group Type: EXPERIMENTAL

CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

Intervention Type: BIOLOGICAL

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.

2mg CryJ2-DNA-LAMP plasmid vaccine Group 3

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.

Group Type: EXPERIMENTAL

CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

Intervention Type: BIOLOGICAL

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.

Interventions

CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.
• Positive blood screen for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbSAg), or Hepatitis C.
• Chronic history of recurrent sinusitis, urticaria or angioedema within the last 12 months.
• History of alcohol or drug abuse within the year prior to the Screening Visit 1, or current evidence of substance dependence or abuse.
• Laboratory Values (hematology, biochemistry, urine tests), that are outside the normal ranges, unless the abnormality is not considered clinically significant by the investigator.
• Participation in a clinical trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit.
• Subjects with anti-LAMP antibodies above the Cutpoint Assay baseline will be excluded.
• Subjects who participated in the prior Phase I A study and experienced a grade 3, severe reaction after vaccination.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 63 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Immunomic Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Fitz-Patrick, MD

Role: PRINCIPAL_INVESTIGATOR

East-West Medical Research Institute

Locations

East West Medical Research Institute

Honolulu, Hawaii, United States

Countries

United States

Other Identifiers

PHIB-2013

Identifier Type: -

Identifier Source: org_study_id