A novel oil-in-water emulsion as a potential adjuvant for influenza vaccine: development, characterization, stability and in vivo evaluation.
Oil-in-water emulsions consisting of squalene, tween and/or span have shown significant benefits for the prevention and control of influenza, with their adjuvant efficacy enhancing the immunogenicities of influenza vaccines in high-risk groups. However, concerns have been raised following reports that post-immunization reactions associated with these adjuvanted vaccines are more frequent. In this work, a stable and biocompatible oil-in-water emulsion adjuvant containing squalene, egg lecithin and sodium oleate has been developed. Animal studies demonstrated that this adjuvant could induce strong immune responses in BALB/c mice, as measured by hemagglutinin inhibition titers, influenza-specific serum antibody titers and cytokine levels (IFN-γ and IL-4). Different oil compositions, including squalene, medium chain triglyceride and long chain triglyceride, were also evaluated. Furthermore, in contrast to MF59(®) which can only be sterilized by aseptic filtration, this adjuvant remained stable during autoclaving, showing minimal changes in pH, particle size and lysolecithin concentration.
Shanghai Institute of Pharmaceutical Industry, Shanghai Engineering Research Center of Lipid Emulsions, Shanghai 200437, PR China.
JiaHua
J
Deng
Shanghai Institute of Pharmaceutical Industry, Shanghai Engineering Research Center of Lipid Emulsions, Shanghai 200437, PR China.
WeiHui
W
Cai
Shanghai Institute of Pharmaceutical Industry, Shanghai Engineering Research Center of Lipid Emulsions, Shanghai 200437, PR China. Electronic address: jfsipi@163.com.
Fang
F
Jin
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000737:chemistry; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood; D002478:Cells, Cultured; D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D045703:Emulsifying Agents / Q000737:chemistry; D004655:Emulsions; D005079:Excipients / Q000737:chemistry; D005260:Female; D006863:Hydrogen-Ion Concentration; D007111:Immunity, Cellular / Q000187:drug effects; D056724:Immunity, Humoral / Q000187:drug effects; D007114:Immunization; D009981:Influenza B virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000737:chemistry / Q000276:immunology; D007371:Interferon-gamma / Q000097:blood; D015847:Interleukin-4 / Q000097:blood; D054709:Lecithins / Q000737:chemistry; D008807:Mice, Inbred BALB C; D009821:Oils / Q000737:chemistry*; D019301:Oleic Acid / Q000737:chemistry; D010316:Particle Size; D011817:Rabbits; D013185:Squalene / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods; D013997:Time Factors; D014867:Water / Q000737:chemistry*
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D045703:Emulsifying Agents; D004655:Emulsions; D005079:Excipients; D007252:Influenza Vaccines; D054709:Lecithins; D009821:Oils; D014867:Water; D015847:Interleukin-4; D019301:Oleic Acid; C013173:osteum; D013185:Squalene; D007371:Interferon-gamma
Adjuvants; Egg lecithin; Influenza vaccine; Oil-in-water emulsion; Squalene