4.5 Article

Novel Biomimetic Reconstituted Built-in Adjuvanted Hepatitis B Vaccine for Transcutaneous Immunization

Journal

JOURNAL OF PHARMACEUTICAL SCIENCES
Volume 108, Issue 11, Pages 3550-3559

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.xphs.2019.07.007

Keywords

transcutaneous immunization; hepatitis B; reconstituted vesicles; TLR-4 agonist

Funding

  1. University Grants Commission (UGC), New Delhi, India

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Transcutaneous immunization is the administration of a vaccine on the skin to generate efficient systemic and mucosal immune responses against an antigen. In the present study, reconstituted hepatitis B surface antigen vesicles (HBsAg-REVs) integrated with monophosphoryl lipid A were prepared by the delipidation-reconstitution method and tested as built-in adjuvanted vaccine, system for transcutaneous immunization using a combined approach of tape strippings, and enhanced antigen skin contact time. Prepared vesicles were extensively characterized for size, shape, zeta potential, and antigen protein loading efficiency. Following topical application, HBsAg-REVs skin permeation on isolated rat skin and cell uptake by bone marrow-derived dendritic cells were determined by confocal laser scanning microscopy and flow cytometry, respectively. The humoral and cellular immune responses elicited by HBsAg-REVs via transcutaneous immunization were comparable to the marketed intramuscular hepatitis B vaccine formulation with predefined immunization protocols. This study supports that delivery of reconstituted HBsAg vesicles via transcutaneous route may open a new vista for designing topical vaccines with possible immune protection against hepatitis B in future. (c) 2019 American Pharmacists Association (R). Published by Elsevier Inc. All rights reserved.

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