title: A Pre-Clinical Safety Evaluation of SBP (HBsAg-Binding Protein) Adjuvant for Hepatitis B Vaccine.
abstract: Although adjuvants are a common component of many vaccines, there are few adjuvants licensed for use in humans due to concerns about their toxic effects. There is a need to develop new and safe adjuvants, because some existing vaccines have low immunogenicity among certain patient groups. In this study, SBP, a hepatitis B surface antigen binding protein that was discovered through screening a human liver cDNA expression library, was introduced into hepatitis B vaccine. A good laboratory practice, non-clinical safety evaluation was performed to identify the side effects of both SBP and SBP-adjuvanted hepatitis B vaccine. The results indicate that SBP could enhance the HBsAg-specific immune response, thus increasing the protection provided by the hepatitis B vaccine. The safety data obtained here warrant further investigation of SBP as a vaccine adjuvant.
authors.affiliation: Laboratory of Molecular Immunology, State Key Laboratory of Genetic Engineering, Institute of Biomedical Science, School of Life Sciences, Fudan University, Shanghai, China.
authors.forename: Jingbo
authors.initials: J
authors.lastname: Wang
authors.affiliation: Laboratory of Molecular Immunology, State Key Laboratory of Genetic Engineering, Institute of Biomedical Science, School of Life Sciences, Fudan University, Shanghai, China.
authors.forename: Caixia
authors.initials: C
authors.lastname: Su
authors.affiliation: Laboratory of Molecular Immunology, State Key Laboratory of Genetic Engineering, Institute of Biomedical Science, School of Life Sciences, Fudan University, Shanghai, China.
authors.forename: Rui
authors.initials: R
authors.lastname: Liu
authors.affiliation: Laboratory of Molecular Immunology, State Key Laboratory of Genetic Engineering, Institute of Biomedical Science, School of Life Sciences, Fudan University, Shanghai, China.
authors.forename: Baoxiu
authors.initials: B
authors.lastname: Liu
authors.affiliation: Laboratory of Molecular Immunology, State Key Laboratory of Genetic Engineering, Institute of Biomedical Science, School of Life Sciences, Fudan University, Shanghai, China.
authors.forename: Inam Ullah
authors.initials: IU
authors.lastname: Khan
authors.affiliation: Laboratory of Molecular Immunology, State Key Laboratory of Genetic Engineering, Institute of Biomedical Science, School of Life Sciences, Fudan University, Shanghai, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Xie
authors.affiliation: Laboratory of Molecular Immunology, State Key Laboratory of Genetic Engineering, Institute of Biomedical Science, School of Life Sciences, Fudan University, Shanghai, China.
authors.forename: Naishuo
authors.initials: N
authors.lastname: Zhu
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000633:toxicity; D000818:Animals; D002352:Carrier Proteins / Q000008:administration & dosage* / Q000276:immunology / Q000633:toxicity; D004353:Drug Evaluation, Preclinical; D005260:Female; D006168:Guinea Pigs; D006510:Hepatitis B Antibodies / Q000096:biosynthesis; D006514:Hepatitis B Surface Antigens / Q000276:immunology / Q000378:metabolism*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000276:immunology / Q000633:toxicity; D006801:Humans; D008252:Macaca fascicularis; D008297:Male; D051379:Mice; D008813:Mice, Inbred ICR; D051381:Rats; D017207:Rats, Sprague-Dawley
chemical_list: D000276:Adjuvants, Immunologic; D002352:Carrier Proteins; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines