Allergic RhinitisPhase 1NCT02146781
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 Phase 1 study testing CryJ2-DNA-LAMP plasmid vaccine by intradermal injection in people with Allergic Rhinitis, run by Immunomic Therapeutics, Inc. at 1 site in United States.
Trial summary
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 using a different route of administration, the Intradermal (ID) route. Read more about this study
- Who is it for?
- Ages 18 to 63 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- CryJ2-DNA-LAMP plasmid vaccine by intradermal injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Mar 2015
- 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 subjects between the ages of 18 and 63 years, who are either:
- Japanese Red Cedar pollen or Mountain Cedar positive in skin tests, or
- Presence of anti-CryJ2 antibodies. Subjects will be assigned to Cohorts 1, 2 and 3. Half of cohort 1 will be composed of Japanese Red Cedar pollen or Mountain Cedar positive atopic subjects, the other half composed of non-atopic subjects.
- Execute a written informed consent (in English and where appropriate; in Japanese if subject prefers) to participate in the study.
- For subjects to be enrolled in Cohorts 2, 3 and half of cohort 1, 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 >3 mm 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).
- Subjects will be healthy without any 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 not 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, including their availability for the study period.
Who cannot join
- Previous Japanese red cedar allergen immunotherapy [(Subcutaneous Immunotherapy (SCIT), oral immunotherapy, SLIT (Sublingual Immunotherapy), 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 is 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 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.
- Forced Expiratory Volume 1 (FEV1) of <70% as measured 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), that are outside the normal ranges, unless the abnormality is not considered clinically significant by the Principal 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 have suffered from general fatigue without etiology during the previous six (6) months will be excluded from the study. Fatigue is characterized by a lessened capacity or motivation for work and reduced efficiency of accomplishment, usually accompanied by a feeling of weariness, sleeplessness, and muscle tiredness.
Trial locations and contacts
1 site in 1 country.
United States1 site
East West Medical Research Institute
Honolulu, Hawaii, 96814
About this study
Official title: 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
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 using a different route of administration, the Intradermal (ID) route. 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 IC study to assess and evaluate the safety and immunological responses to therapeutic doses of a dosing regimen of 1.08 mg and 2.16 mg of CryJ2-DNA-LAMP plasmid vaccine delivered intradermally (ID) using the Biojector 2000 device, to be administered every 14 days in subjects with atopic sensitivity to Japanese Red Cedar pollen, identified by skin test reactivity to this pollen. The protocol has three subject cohorts: a Cohort 1: composed of atopic and non-atopic subjects (half atopic and half non-atopic), who will only receive saline control administered using the Biojector 2000 device; a Cohort 2: atopic subjects, who will receive 2.16 mg per dose in a four (4) dose regimen using a Biojector 2000 device; and a Cohort 3: atopic subjects, who will receive 1.08 mg per dose in a four (4) dose regimen vaccinated using a Biojector 2000 device.The study will be conducted at 1 study center. Subjects are enrolled in the trial for a period of 132 days. The objectives of the statistical analyses are to establish the safety and to explore the immunogenicity of the LAMP-vax vaccine using a different route of administration, the Intradermal (ID) route. All statistical analyses conducted on the data from this trial will be exploratory in nature.
The primary objective of this Phase IC Study is to evaluate the safety and immunological responses of therapeutic doses and the dosing regimen of CryJ2-DNA-LAMP plasmid vaccine delivered intradermally (ID) using the Biojector 2000 device.
Read the detailed description
A safety and Immunological assessment of JRC sensitive (atopic) subjects will be assessed in terms of current skin test reactivity. 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 to one of 3 study vaccine cohorts:
Cohort 1: These Japanese Red Cedar atopic and non-atopic subjects will be recruited as a placebo control. This cohort will be composed of 5 atopic and 5 non-atopic subjects (half of the subjects will be atopic and half non-atopic), that will receive 4 vaccinations, 14 days apart, of a saline control in four separate 0.200 ml volumes administered Intradermally (ID) using the needle-free Biojector device.
Cohort 2: These Japanese Red Cedar atopic subjects will receive intradermal (ID) injections of the same CryJ2-DNA-LAMP vaccine previously used in Phase IA and IB studies. Cohort #2 will receive four (4) 2.16 mg doses at 14 day intervals. Each 2.16 mg dose will require administration of four (4) separate 0.200 ml volumes of a 2.7 mg/ml vaccine concentrate using the needle-free Biojector device. Each of the four volumes will be injected at different sites on the same or different deltoid muscle.
Cohort 3: These Japanese Red Cedar atopic subjects will receive intradermal (ID) injections of the same CryJ2-DNA-LAMP vaccine previously used in Phase IA and IB studies. Cohort #3 will receive four (4) 1.08 mg doses at 14 day intervals. Each 1.08 mg dose will require administration of two (2) separate 0.200 ml volumes of a 2.7 mg/ml vaccine concentrate using the needle-free Biojector device. Each of the four volumes will be injected at different sites on the same or different deltoid muscle.
There will be between 18 to 26 men and women participating in the study at one location. Your participation in this study will last approximately 132 days.
- Conditions
- Allergic Rhinitis
- Being tested
- CryJ2-DNA-LAMP plasmid vaccine by intradermal injection, Saline Control
- Medical subject headings
- Rhinitis, Allergic
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 intradermal 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 intradermal injection using the Biojector 2000 devibe.
Saline ControlOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 0.80 mL Saline Placebo Cohort 1 | Placebo comparator | 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. Receives: Other: Saline Control |
| 2.16 mg of CryJ2-DNA-LAMP plasmid vaccine Cohort 2 | Experimental | 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 Receives: Biological: CryJ2-DNA-LAMP plasmid vaccine by intradermal injection |
| 1.08 mg CryJ2-DNA-LAMP plasmid vaccine Cohort 3 | Experimental | 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 Receives: Biological: CryJ2-DNA-LAMP plasmid vaccine by intradermal 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 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
Measured: 132 Days (+/-)
Secondary outcomes (1)
Immunogenicity and functional variables [Japanese Red Cedar Immunocap (IgE & IgG), Mountain Cedar Immunocap (IgE) & Th1/Th2 cytokines ELISA Panel]
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
Measured: 132 days (+/-)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunomic Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Fitz-Patrick, MD, Principal investigator, East-West Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146781
- Sponsor's protocol ID
- ITI PH IC- 2014
- Status last verified
- Mar 2015
- First submitted
- 30 Apr 2014
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02146781
- Acronym / sponsor ID
- ITI PH IC- 2014
- Conditions
- Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Immunomic Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 26 May 2014 (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.
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 using a different route of administration, the Intradermal (ID) route. 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 IC study to assess and evaluate the safety and immunological responses to therapeutic doses of a dosing regimen of 1.08 mg and 2.16 mg of CryJ2-DNA-LAMP plasmid vaccine delivered intradermally (ID) using the Biojector 2000 device, to be administered every 14 days in subjects with atopic sensitivity to Japanese Red Cedar pollen, identified by skin test reactivity to this pollen. The protocol has three subject cohorts: a Cohort 1: composed of atopic and non-atopic subjects (half atopic and half non-atopic), who will only receive saline control administered using the Biojector 2000 device; a Cohort 2: atopic subjects, who will receive 2.16 mg per dose in a four (4) dose regimen using a Biojector 2000 device; and a Cohort 3: atopic subjects, who will receive 1.08 mg per dose in a four (4) dose regimen vaccinated using a Biojector 2000 device.The study will be conducted at 1 study center. Subjects are enrolled in the trial for a period of 132 days. The objectives of the statistical analyses are to establish the safety and to explore the immunogenicity of the LAMP-vax vaccine using a different route of administration, the Intradermal (ID) route. All statistical analyses conducted on the data from this trial will be exploratory in nature.
The primary objective of this Phase IC Study is to evaluate the safety and immunological responses of therapeutic doses and the dosing regimen of CryJ2-DNA-LAMP plasmid vaccine delivered intradermally (ID) using the Biojector 2000 device.
Detailed description
A safety and Immunological assessment of JRC sensitive (atopic) subjects will be assessed in terms of current skin test reactivity. 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 to one of 3 study vaccine cohorts:
Cohort 1: These Japanese Red Cedar atopic and non-atopic subjects will be recruited as a placebo control. This cohort will be composed of 5 atopic and 5 non-atopic subjects (half of the subjects will be atopic and half non-atopic), that will receive 4 vaccinations, 14 days apart, of a saline control in four separate 0.200 ml volumes administered Intradermally (ID) using the needle-free Biojector device.
Cohort 2: These Japanese Red Cedar atopic subjects will receive intradermal (ID) injections of the same CryJ2-DNA-LAMP vaccine previously used in Phase IA and IB studies. Cohort #2 will receive four (4) 2.16 mg doses at 14 day intervals. Each 2.16 mg dose will require administration of four (4) separate 0.200 ml volumes of a 2.7 mg/ml vaccine concentrate using the needle-free Biojector device. Each of the four volumes will be injected at different sites on the same or different deltoid muscle.
Cohort 3: These Japanese Red Cedar atopic subjects will receive intradermal (ID) injections of the same CryJ2-DNA-LAMP vaccine previously used in Phase IA and IB studies. Cohort #3 will receive four (4) 1.08 mg doses at 14 day intervals. Each 1.08 mg dose will require administration of two (2) separate 0.200 ml volumes of a 2.7 mg/ml vaccine concentrate using the needle-free Biojector device. Each of the four volumes will be injected at different sites on the same or different deltoid muscle.
There will be between 18 to 26 men and women participating in the study at one location. Your participation in this study will last approximately 132 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.80 mL Saline Placebo Cohort 1 | Placebo comparator | Other: Saline ControlHealthy 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. |
| 2.16 mg of CryJ2-DNA-LAMP plasmid vaccine Cohort 2 | Experimental | Biological: CryJ2-DNA-LAMP plasmid vaccine by intradermal injectionHealthy 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 |
| 1.08 mg CryJ2-DNA-LAMP plasmid vaccine Cohort 3 | Experimental | Biological: CryJ2-DNA-LAMP plasmid vaccine by intradermal injectionHealthy 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 |
Who may qualify
- Ages
- 18 to 63 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female subjects between the ages of 18 and 63 years, who are either:
- Execute a written informed consent (in English and where appropriate; in Japanese if subject prefers) to participate in the study.
- For subjects to be enrolled in Cohorts 2, 3 and half of cohort 1, 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 >3 mm 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).
- Subjects will be healthy without any 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 not jeopardize the safety of the subject or impact the validity of the study results.
Key exclusion criteria (19 listed)
- Previous Japanese red cedar allergen immunotherapy [(Subcutaneous Immunotherapy (SCIT), oral immunotherapy, SLIT (Sublingual Immunotherapy), 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 is 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 intradermal 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 intradermal injection using the Biojector 2000 devibe. | Biological | 1.08 mg CryJ2-DNA-LAMP plasmid vaccine Cohort 3, 2.16 mg of CryJ2-DNA-LAMP plasmid vaccine Cohort 2 |
| Saline ControlThe 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). | Other | 0.80 mL Saline Placebo Cohort 1 |
Primary outcome
Number of participants with Adverse Events
Time frame: 132 Days (+/-)
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
1 secondary outcome
Immunogenicity and functional variables [Japanese Red Cedar Immunocap (IgE & IgG), Mountain Cedar Immunocap (IgE) & Th1/Th2 cytokines ELISA Panel]
Time frame: 132 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 25 Mar 2015.
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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-West 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 intradermal injection in people with Allergic Rhinitis, 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 8 inclusion and 19 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 25 Mar 2015. 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. Some participants in this study may receive a placebo. 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: 132 Days (+/-)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2015.