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

NCT01966224 | Completed Phase 1

• 1 other identifier: PHIB-2013
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events

  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.

  80 days (+/-)

Secondary Outcomes (1)

• Immunogenicity and functional variables [Japanese Red Cedar Immunocap (IgE & IgG), Mountain Cedar Immunocap (IgE) & Th1/Th2 cytokines ELISA Panel]

  80 days (+/-)

Study Arms (3)

2mg CryJ2-DNA-LAMP plasmid vaccine Group 1

EXPERIMENTAL

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.

Biological: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

2mg CryJ2-DNA-LAMP plasmid vaccine Group 2

EXPERIMENTAL

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.

Biological: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

2mg CryJ2-DNA-LAMP plasmid vaccine Group 3

EXPERIMENTAL

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.

Biological: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

Interventions

CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection 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 1; 2mg CryJ2-DNA-LAMP plasmid vaccine Group 2; 2mg CryJ2-DNA-LAMP plasmid vaccine Group 3

Eligibility Criteria

• Age: 18 Years - 63 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunomic Therapeutics, Inc.: lead

Study Sites (1)

East West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Study Officials

• David Fitz-Patrick, MD

  East-West Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 21, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

US (1)