期刊
HUMAN VACCINES & IMMUNOTHERAPEUTICS
卷 13, 期 12, 页码 2804-2813出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/21645515.2017.1329070
关键词
CryJ2; DNA Vaccine; JRC Allergy; LAMP; Skin Test
资金
- Immunomic Therapeutics, Inc.
Japanese Red Cedar (JRC) pollen induced allergy affects one third of Japanese and the development of effective therapies remains an unachieved challenge. We designed a DNA vaccine encoding CryJ2 allergen from the JRC pollen and Lysosomal Associated Membrane Protein 1 (LAMP-1) to treat JRC allergy. These Phase IA and IB trials assessed safety and immunological effects of the investigational CryJ2-LAMP DNA vaccine in both non-sensitive and sensitive Japanese expatriates living in Honolulu, Hawaii. In the Phase IA trial, 6 JRC non-sensitive subjects and 9 JRC and/or Mountain Cedar (MC) sensitive subjects were given 4 vaccine doses (each 4mg/1ml) intramuscularly (IM) at 14-day intervals. Nine JRC and/or MC sensitive subjects were given 4 doses (2mg/0.5ml) IM at 14-day intervals. The safety and functional biomarkers were followed for 132d. Following this, 17 of 24 subjects were recruited into the IB trial and received one booster dose (2mg/0.5ml) IM approximately 300d after the first vaccination dose to which they were randomized in the first phase of the trial. All safety endpoints were met and all subjects tolerated CryJ2-LAMP vaccinations well. At the end of the IA trial, 10 out of 12 JRC sensitive and 6 out of 11 MC sensitive subjects experienced skin test negative conversion, possibly related to the CryJ2-LAMP vaccinations. Collectively, these data suggested that the CryJ2-LAMP DNA vaccine is safe and may be immunologically effective in treating JRC induced allergy.
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