title: Humoral and cell-mediated immune-responses after administration of a single-shot recombinant hepatitis B surface antigen vaccine formulated with cationic poly(l-lactide) microspheres.
abstract: The present investigations were aimed to compare the humoral and cell-mediated immune responses between recombinant hepatitis B surface antigens (HBsAg) adsorbed L-PLA microspheres (Ms) vaccine (single-shot) and marketed alum-HBsAg vaccine (two-doses). The blank cationic (cetyltrimethyammoniumbromide) microspheres were prepared by the double emulsion (w/o/w) solvent evaporation technique. The HBsAg was adsorbed onto the surface of blank cationic microspheres. These microspheres were characterized in vitro for their size, shape, adsorption-efficiency, in-process stability, and HBsAg release studies. Specific humoral immune responses (IgM and IgG) and cell-mediated immune responses (cellular-proliferation) assay including release of interferon-gamma (IFN-gamma), interleukin-2 (IL-2), and nitric oxide (NO) from host's cells stimulated with HBsAg or lipopolysaccharide (LPS)/ concanavalin A (con A) in-vitro were determined. Based on these findings, it was concluded that the single injection (using subcutaneous-route) of the polymeric microspheres produced better immune response (both humoral and cell-mediated) than two injections of a conventional alum-HBsAg vaccine. These data demonstrate high potential of polymeric microspheres for their use as a carrier adjuvant for hepatitis B vaccine.
authors.affiliation: Biopharmaceuticals Research Laboratory, Deparment of Pharmaceutical Sciences, Dr. Harisingh Gour University, Madhya Pradesh, India.
authors.forename: Vinay
authors.initials: V
authors.lastname: Saini
authors.forename: Vikas
authors.initials: V
authors.lastname: Jain
authors.forename: M S
authors.initials: MS
authors.lastname: Sudheesh
authors.forename: Saurabh
authors.initials: S
authors.lastname: Dixit
authors.forename: R L
authors.initials: RL
authors.lastname: Gaur
authors.forename: M K
authors.initials: MK
authors.lastname: Sahoo
authors.forename: S K
authors.initials: SK
authors.lastname: Joseph
authors.forename: S K
authors.initials: SK
authors.lastname: Verma
authors.forename: K S
authors.initials: KS
authors.lastname: Jaganathan
authors.forename: P K
authors.initials: PK
authors.lastname: Murthy
authors.forename: Dharmveer
authors.initials: D
authors.lastname: Kohli
mesh_terms: D000818:Animals; D002412:Cations; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004337:Drug Carriers / Q000737:chemistry*; D004655:Emulsions; D006514:Hepatitis B Surface Antigens / Q000008:administration & dosage / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000276:immunology*; D007111:Immunity, Cellular; D056724:Immunity, Humoral; D007279:Injections, Subcutaneous; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D008863:Microspheres; D010316:Particle Size; D011091:Polyesters / Q000737:chemistry*
chemical_list: D002412:Cations; D004337:Drug Carriers; D004655:Emulsions; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011091:Polyesters; C033616:poly(lactide)