Examine safety and immunological response for ASP4070 when vaccinated in patients with pollen allergy
This study consists of 2 parts: Part 1 and Part 2. \[Part 1\] An open-label, un-controlled study Examine the safety for the ASP4070 intramuscular vaccination group (high dose x 4 times) and the ASP4070 intradermal vaccination group (high dose x 4 times). \[Part 2\] A placebo-controlled, double-blinded, randomized, parallel-group comparative study Assess the immunological response and safety for the ASP 4070 intramuscular vaccination group (high dose x 1 time and high dose x 4 times) and the ASP4070 intradermal vaccination group (low dose x 1 time, low x 4 times, high dose x 1 time, and high dose x 4 times) as compared to those for the placebo group. The study will be double-blinded within the same route of vaccination, and non-blinded between the routes of vaccination (between the intramuscular vaccination group and intradermal vaccination group). The first vaccination to the subjects in Part 2 will start at least 14 days after the first vaccination to the subjects in Part 1 (6 subjects). For both Part 1 and Part 2, primary study period is for 3 months starting from the last dose of the study drug at Day 43 (until Day 127). After the primary study period, safety information will be collected for 9 months (for 1 year from the last dose of the study drug) as the long-term safety follow-up study period. Safety information will be collected for 1 year starting from the last vaccination of the study drug also from the patients who discontinued the participation in the study during the primary study period if the patients agree.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
66
Unnamed facility
Kanto, Japan
Adverse events developed after the first vaccination of the study drug
Time frame: Up to Day 127
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
Time frame: within 14 days after the vaccination of the study drug
Vital signs (axillary temperature, blood pressure in a sitting position, and pulse rate in a sitting position)
Time frame: Screening period, :Day 1, 15, 29, 43, 71, 99, and 127
12-lead ECG
ECG: Electrocardiogram
Time frame: Day 1 and 43
Laboratory test (hematology, biochemistry, and urinalysis)
Time frame: Screening period, Day 1, 43, and 127
Prick test for Japanese cedar pollen
Time frame: Screening period, Day 15, 29, 43, 71, 99 and 127
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
Time frame: Day 1, 71, 99 and 127
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