Abstract
Background: Viral infection caused by Hepatitis B is transmitted by permucosal or parenteral exposure and also one of the prime causes of hepatocellular carcinoma and liver cirrhosis. Objectives: M-cell targeting acid-resistant oral vaccine delivery have been formulated for immunization against Hepatitis B infection. Methods: Cationic solid lipid nanoparticles (cSLNs) were prepared utilizing solvent injection technique. Hepatitis B surface antigen (HBsAg) loaded alginate coated cSLNs were anchored with lipopolysaccharide (LPS). SDS-PAGE was performed to evaluate acid degradation protection of prepared formulation. Induction of immunity produced by prepared nanoparticle for Hepatitis B was determined on female Balb/c mice followed by ELISA assays for assessing anti-HBsAg IgG/IgA antibodies in mucosal fluids. Results: Sustained release of HBsAg (60.66 %) has been exhibited from alginate coated cSLNs in comparison to cSLNs without alginate coating (97.72 %) after 48 h. The production of anti-HBs titer in intestinal, salivary and vaginal secretions was 3.41 IU/ml, 3.1 IU/ml and 2.51 IU/ml respectively in comparison to the control group. Integrity of the M-cells has been maintained after binding with SLN, and oral administration delivered the antigen to the desired site of gut. Conclusion: It was found effective in producing antibodies in mucosal immunization against Hepatitis B virus. So, this formulation could be used as a promising alternative preexisting vaccine to prevent Hepatitis B infection.
The construction of in vitro nasal cavity-mimic M-cell model, design of M cell-targeting nanoparticles and evaluation of mucosal vaccination by nasal administration