title: Current status of synthetic hemozoin adjuvant: A preliminary safety evaluation.
abstract: Although adjuvants are a "must-have" component of successful vaccines, there are very few adjuvants licensed for use in humans, there is therefore an urgent need to develop new and safer adjuvants. Synthetic hemozoin (sHZ), a chemical analog of hemozoin which is produced by the malaria parasite, exhibits a potent adjuvant effect which enhances antigen-specific immune responses to vaccines. The potency of sHZ adjuvanticity is not limited to malaria specific vaccines, it has also been demonstrated to be effective in influenza and dog allergy models. While the synthesis of uniformly sized sHZ with consistent characteristics has proven difficult, we have recently successfully optimized the manufacture of sHZ product with an optimal adjuvant effect. Here, we summarize recent developments on the adjuvant properties of optimized sHZ adjuvant, including its good laboratory practice (GLP) non-clinical safety profile in animals. These studies ensure the safety of optimized sHZ product to be readily used as vaccine adjuvant beforehand in veterinary medicine.
authors.affiliation: Laboratory of Malaria Immunology, Immunology Frontier Research Center (IFReC), Osaka University, Osaka, Japan.
authors.forename: Michelle Sue Jann
authors.initials: MS
authors.lastname: Lee
authors.affiliation: ZENOAQ-Nippon Zenyaku Kogyo Co., Ltd, Fukushima, Japan.
authors.forename: Yoshikatsu
authors.initials: Y
authors.lastname: Igari
authors.affiliation: ZENOAQ-Nippon Zenyaku Kogyo Co., Ltd, Fukushima, Japan.
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Tsukui
authors.affiliation: Laboratory of Adjuvant Innovation, National Institute of Biomedical Innovation, Health and Nutrition (NIBIOHN), Osaka, Japan; Laboratory of Vaccine Science, IFReC, Osaka University, Osaka, Japan.
authors.forename: Ken J
authors.initials: KJ
authors.lastname: Ishii
authors.affiliation: Laboratory of Malaria Immunology, Immunology Frontier Research Center (IFReC), Osaka University, Osaka, Japan. Electronic address: ccoban@biken.osaka-u.ac.jp.
authors.forename: Cevayir
authors.initials: C
authors.lastname: Coban
mesh_terms: D000276:Adjuvants, Immunologic / Q000138:chemical synthesis / Q000737:chemistry*; D000818:Animals; D006420:Hemeproteins / Q000138:chemical synthesis / Q000737:chemistry*; D006801:Humans; D007252:Influenza Vaccines / Q000737:chemistry; D017780:Malaria Vaccines / Q000737:chemistry; D010961:Plasmodium / Q000737:chemistry; D018675:Toxicity Tests
chemical_list: D000276:Adjuvants, Immunologic; D006420:Hemeproteins; D007252:Influenza Vaccines; D017780:Malaria Vaccines; C020753:hemozoin
keywords: Adjuvant; Non-clinical toxicity; Safety; Synthetic hemozoin