Cedar Pollinosis Clinical Trial
Official title:
A Phase 1 Study of ASP4070 to Confirm the Safety and Immunological Response in Patients With Cedar Pollinosis When Administered as Intramuscular Vaccination and as Intradermal Vaccination
| Verified date | January 2020 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen allergy
| Status | Completed |
| Enrollment | 66 |
| Est. completion date | July 26, 2016 |
| Est. primary completion date | November 27, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 64 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc | Immunomic Therapeutics, Inc. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse events developed after the first vaccination of the study drug | Up to Day 127 | ||
| Secondary | Local reaction(injection site pain, erythema, swelling, and induration) and systemic reaction(queasy, vomiting, diarrhoea, headache, malaise, myalgia, allergic reaction, and pyrexia) due to the vaccination developed | within 14 days after the vaccination of the study drug | ||
| Secondary | Vital signs (axillary temperature, blood pressure in a sitting position, and pulse rate in a sitting position) | Screening period, :Day 1, 15, 29, 43, 71, 99, and 127 | ||
| Secondary | 12-lead ECG | ECG: Electrocardiogram | Day 1 and 43 | |
| Secondary | Laboratory test (hematology, biochemistry, and urinalysis) | Screening period, Day 1, 43, and 127 | ||
| Secondary | Prick test for Japanese cedar pollen | Screening period, Day 15, 29, 43, 71, 99 and 127 | ||
| Secondary | Parameters developed by antibody and histamine release test | Antibody: IgG antibody, specific IgG antibody (anti-JRC, anti-Cry j 1, and anti-Cry j 2), specific IgG4 antibody (anti-JRC), IgE antibody, specific IgE antibody (anti-JRC), cytokine (IFN-gamma, IL-4, IL-5, IL-10, IL-12, and IL-13), anti-LAMP antibody | Day 1, 71, 99 and 127 |