A Study of ASP4070 to Confirm Safety and Immunological Response in Patients With Pollen Allergy

• Status: Completed
• Trial end date: 2016-07-26
• Target enrollment: 0
• Participant gender: All

Summary

Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen allergy

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Immunomic Therapeutics, Inc.
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Subject who has medical history of nasal symptoms (sneezing, itching, rhinorrhoea, and congestion), and/or eye symptoms (itching, redness, and lacrimation) at least in 2 cedar pollen dispersion seasons prior to the screening test.

• Subject who had the Japanese cedar pollen-specific antibody test result of Class 3 or higher in the allergy test at screening.

• Subject who had a positive prick test result for Japanese cedar pollen in the screening test.

• Subject whose past and present medical conditions are considered medically stable.

Exclusion Criteria:

• Subject who had the test result of IgE antibody specific to other antigen than Japanese cedar pollen

• Subject who is scheduled to receive other vaccination during the primary study period.

• Subject who has received or is planning to receive vaccination of live vaccine within 28 days prior to the first vaccination of the study drug, and/or a subject who has received or is planning to receive vaccination of inactivated vaccine/toxoid within 7 days prior to the first vaccination of the study drug.

• Subject who received specific immunotherapy for cedar pollinosis in the past.

• Subject who received specific or non-specific immunotherapy within 5 years prior to the screening test.

• Subject who has used the following drug(s) prior to the first vaccination of the study drug:

• Within 56 days prior to the first vaccination of the study drug: Topical steroid, histamine H1-receptor antagonist, chemical mediator-isolation inhibitor, Th2 cytokine inhibitor, thromboxane A2 synthesis inhibitor, thromboxane A2 receptor antagonist, and/or leukotriene receptor antagonist

• Within 84 days prior to the first vaccination of the study drug: Systemic steroid, and antibody drugs (including anti-TNF-alpha antibody and anti-IgE monoclonal antibody)

• Subject who has history of allergic reactions such as anaphylactic shock and exanthema generalized caused by food and/or medical products (including vaccine) in the past, and/or a subject who had a fever of 39.0 degrees Celsius or higher within 2 days after the previous vaccination.

• Subject who has evidently high fever (37.5 degrees Celsius or higher) on the day of vaccination, or subject who has severe acute disease.

• Subject who meets any of the following criteria for laboratory and other tests at screening. The reference range for each test is the range used in the study site.

• Blood biochemistry test:

1. AST (GOT) or ALT (GPT) value over 100 IU/L

2. Creatinine value over 1.5 mg/dL

• Urine drug screening:

1. Subject who had a positive drug test result for: benzodiazepines, cocaine and similar narcotics, stimulant drugs, cannabis, barbituric acids, morphine and similar narcotics, PCPs, or tricyclic antidepressants.

• Immunological test:

1. Subject who had a positive test results for HBs antigen, HCV antibody, or HIV antigen/antibody

• Subject who has autoimmune disease or other serious primary disease.

• Subject who was diagnosed with immunodeficiency in the past.

• Subject who has a complication of perennial allergic rhinitis, rhinitis medicamentosa, or non-allergic rhinitis which requires medical treatment.

• Subject who has a complication of cardiovascular disease (including cardiac failure congestive, angina pectoris, and cardiac arrhythmias which requires medical treatment).

• Subject who has a complication of hepatic disease (including hepatitis viral and drug-induced liver injury).

• Subject who has a complication of renal disease (including acute kidney injury, glomerulonephritis, and nephritis interstitial, but not including medical history of calculus).

• Subject who has a complication of respiratory disease (including asthma bronchial which requires medical treatment, and bronchitis chronic, but not including medical history of asthma in the childhood).

• Subject has a complication of malignant tumor or has been diagnosed or has received treatment for malignant tumor within 5 years prior to the first vaccination of the study drug.

• Subject who was diagnosed with schizophrenia, other mental conditions including bipolar disorder and major depressive disorder, or dementia, or a subject who has received drug(s) for the treatment of dementia.

• Subject who has a complication of dermatitis atopic.

• Subject who has a complication which may have an impact on the results of the local and systemic reaction or prick test assessment.

• Subject who has received a vaccination of Cryj2-LAMP vaccine.