Allergic RhinoconjunctivitisPhase 1NCT01707069

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

A Phase 1 study testing CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection in people with Allergic Rhinoconjunctivitis, run by Immunomic Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 63 yearsHealthy volunteers can take part
Conditions the study is for: Allergic Rhinoconjunctivitis
What is being tested?: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Oct 2012to Jun 2013
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 63 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male and female patients between the ages of 18 and 63 years, are either:
Japanese Red Cedar pollen or Mountain Cedar negative in skin tests and lack the presence of anti-Cry j 2 antibodies (To be assigned to Group 1)
Japanese Red Cedar pollen or Mountain Cedar positive in skin tests and/or presence of anti-CryJ2 antibodies (to be assigned to Group 2 or 3).
For the purposes of this study, retrospective skin testing data (as long as it has been performed within 60 days of screening) will be accepted, using the same positive inclusion criteria
Execute a written informed consent (in English and where appropriate in Japanese) to participate in the study.
A minimum 1-year history of seasonal rhinoconjunctivitis (Nasal symptoms: sneezing, itching, rhinorrhea, congestion; Ocular symptoms: itching, redness, watering; Other: itching ears/throat) on exposure to Japanese Red Cedar pollen and/or Mountain Cedar pollen. Subjects have a clinical history that includes symptoms of allergic rhinitis during the Japanese Red Cedar or Mountain Cedar season and when exposed to Japanese Red Cedar and/or Mountain Cedar pollen.

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Documented allergy to Japanese Red Cedar pollen as demonstrated by a positive epicutaneous skin test for Japanese Red Cedar pollen or Mountain Cedar antigen (wheal > 3mm greater than the negative control). Although, the subjects may have positive skin tests to other allergens, these will not be used to qualify or 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 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.

Who cannot join

Previous Japanese red cedar allergen immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide)
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 permitted)
Subjects receiving anti-IgE monoclonal antibodies.
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.

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History of organ transplant, hematologic malignancy, autoimmune disease, myocardial infarction, or congestive heart failure.
History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic diseases, 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 Visit 1 and for the duration of the study. 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.
FEV1 of <70% as measure by spirometry.
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, PFT) 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

East West Medical Research Institute
Honolulu, Hawaii, 96814

Other trials in United States

About this study

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 in various doses. 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. This is the first time that CryJ2-DNA-LAMP Plasmid vaccine is being given to humans.

The purpose of this study is to evaluate the safety of an investigational vaccine intended to treat allergy to Japanese red cedar. The vaccine is composed of DNA, which is the material that cells use to provide instructions to make proteins. The DNA carries the information necessary to make a special protein which is a combination of a protein found in all cells, LAMP (lysosomal associated membrane protein), and the protein from Japanese red cedar that causes the allergy known as Cry J2. This vaccine is intended to help re-educate the immune system with respect to how it will respond to naturally occurring red cedar allergen and eliminate the allergic symptoms. Another purpose of this study will be to document the immune response to the vaccine

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 and chance (like flipping a coin) to one of 3 study vaccine groups:

Group 1: will receive four (4) 4-milligram doses of the study vaccine. Group 2: will receive four (4) 2-milligram doses of the study vaccine. Group 3: will receive four (4) 4-milligram doses of the study vaccine.

The study vaccine is administered as an intramuscular injection. Enrolled subjects will receive the study vaccine every 14 days (at day 0, 14, 28 and 42). Subjects will know their study vaccine assignment. Participants who are not allergic to Japanese red cedar will be assigned to Group 1. Participants who do have an allergy to Japanese red cedar or Mountain Cedar will have an equal chance of being assigned to Group 2 or 3.

There will be between 18 to 30 men and women participating in the study at one location. Your participation in this study will last approximately 72 days.

Read the detailed description

The study is a Phase I, prospective, three cohort, open label study conducted on one cohort of non-atopic subjects and two cohorts of patients with a history of allergic rhinitis symptoms to Japanese red cedar Cry j 2 pollen allergen. The study will be conducted at 1 study center. Subjects are enrolled in the trial for a period of 72 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.

Conditions: Allergic Rhinoconjunctivitis
Being tested: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CryJ2-DNA-LAMP plasmid vaccine by intramuscular injectionBiological
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.

Study groups in NCT01707069
Study group	Role	What they receive
Group 1: 4mg CryJ2-DNA-LAMP plasmid vaccine	Experimental	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. Receives: Biological: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection
Group 2: 2mg CryJ2-DNA-LAMP plasmid vaccine	Experimental	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). Receives: Biological: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection
Group 3: 4 mg CryJ2-DNA-LAMP plasmid vaccine	Experimental	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). Receives: Biological: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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 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.
Measured: 72 days

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Jun 2013

First posted15 Oct 2012 (estimated)
Study startOct 2012
Primary completionMay 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Allergic RhinoconjunctivitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01707069
Sponsor's protocol ID: PHI-2012
Status last verified: May 2014
First submitted: 10 Oct 2012
Last updated: 22 May 2014
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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All Allergic Rhinoconjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety and Immunogenicity Phase I Study of CryJ2-DNA-Lysosomal Associated Membrane Protein (CryJ2 -DNA-LAMP) Plasmid
ClinicalTrials.gov ID: NCT01707069
Acronym / sponsor ID: PHI-2012
Conditions: Allergic Rhinoconjunctivitis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Immunomic Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: May 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 15 Oct 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

There will be between 18 to 30 men and women participating in the study at one location. Your participation in this study will last approximately 72 days.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1: 4mg CryJ2-DNA-LAMP plasmid vaccine	Experimental	Biological: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injectionHealthy 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.
Group 2: 2mg CryJ2-DNA-LAMP plasmid vaccine	Experimental	Biological: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injectionHealthy 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).
Group 3: 4 mg CryJ2-DNA-LAMP plasmid vaccine	Experimental	Biological: CryJ2-DNA-LAMP plasmid vaccine by intramuscular injectionHealthy 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).

Who may qualify

Ages: 18 to 63 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Male and female patients between the ages of 18 and 63 years, are either:
Execute a written informed consent (in English and where appropriate in Japanese) to participate in the study.
A minimum 1-year history of seasonal rhinoconjunctivitis (Nasal symptoms: sneezing, itching, rhinorrhea, congestion; Ocular symptoms: itching, redness, watering; Other: itching ears/throat) on exposure to Japanese Red Cedar pollen and/or Mountain Cedar pollen. Subjects have a clinical history that includes symptoms of allergic rhinitis during the Japanese Red Cedar or Mountain Cedar season and when exposed to Japanese Red Cedar and/or Mountain Cedar pollen.
Documented allergy to Japanese Red Cedar pollen as demonstrated by a positive epicutaneous skin test for Japanese Red Cedar pollen or Mountain Cedar antigen (wheal > 3mm greater than the negative control). Although, the subjects may have positive skin tests to other allergens, these will not be used to qualify or 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).

Key exclusion criteria (18 listed)

Previous Japanese red cedar allergen immunotherapy (SCIT, oral immunotherapy, SLIT, or recombinant peptide)
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 permitted)
Subjects receiving anti-IgE monoclonal antibodies.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CryJ2-DNA-LAMP plasmid vaccine by intramuscular injectionImmunomic 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.	Biological	Group 1: 4mg CryJ2-DNA-LAMP plasmid vaccine, Group 2: 2mg CryJ2-DNA-LAMP plasmid vaccine, Group 3: 4 mg CryJ2-DNA-LAMP plasmid vaccine

Primary outcome

Number of participants with Adverse Events
Time frame: 72 days
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.

1 secondary outcome

Immunogenicity and functional vairables
Time frame: 72 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.

Related trials for Allergic Rhinoconjunctivitis

RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Fitz-Patrick, MD principal investigator

East East Medical Research Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection in people with Allergic Rhinoconjunctivitis, run by Immunomic Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Adverse Events (time frame: 72 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01707069.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014; AzTrials last refreshed its copy on 6 Nov 2026.