Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

A Self-Emulsified Adjuvant System Containing Alpha-Tocopherol Induced Higher Neutralizing Antibody Responses than a Squalene Only Emulsion Against a Recombinant Cytomegalovirus (CMV) Pentamer Antigen

Rushit N Lodaya
* ORCID logo ,
Amey P Kanitkar
,
Asma Ashraf
,
Douty Bamba
,
Mansoor M. Amiji
* ,
Derek T. O'Hagan
*
Version 1 : Received: 31 October 2022 / Approved: 7 November 2022 / Online: 7 November 2022 (12:18:18 CET)

A peer-reviewed article of this Preprint also exists.

Lodaya, R.N.; Kanitkar, A.P.; Ashraf, A.; Bamba, D.; Amiji, M.M.; O’Hagan, D.T. A Self-Emulsified Adjuvant System Containing the Immune Potentiator Alpha Tocopherol Induces Higher Neutralizing Antibody Responses than a Squalene-Only Emulsion When Evaluated with a Recombinant Cytomegalovirus (CMV) Pentamer Antigen in Mice. Pharmaceutics 2023, 15, 238. Lodaya, R.N.; Kanitkar, A.P.; Ashraf, A.; Bamba, D.; Amiji, M.M.; O’Hagan, D.T. A Self-Emulsified Adjuvant System Containing the Immune Potentiator Alpha Tocopherol Induces Higher Neutralizing Antibody Responses than a Squalene-Only Emulsion When Evaluated with a Recombinant Cytomegalovirus (CMV) Pentamer Antigen in Mice. Pharmaceutics 2023, 15, 238.

Abstract

Research for novel vaccine adjuvants remains a critical need to improve the immune responses to a recombinant vaccine antigen. Emulsion adjuvants such as AS03 and MF59, particularly in the area of Influenza vaccines, have shown antigen dose sparing and allowed reduced immunizations. It was previously demonstrated that these emulsion adjuvants can be formulated using a simpler, low shear process of self-emulsification. The role of alpha tocopherol as an immunomodulator in emulsion adjuvants is evident from the success of AS03 in the on-going covid-19 pandemic. Although, it was a challenge to formulate alpha tocopherol with a low shear process to get closer to the AS03 composition, the self-emulsified version referred as self-emulsifying adjuvant systems (SE-AS) showed comparable immune responses to AS03 when co-administered with a Quadrivalent influenza virus (QIV) vaccine. In this paper, we first optimized the SE-AS with alpha tocopherol referred to as SE-AS44 to allow sterile filtration. We compared the in vitro cytokine profile with self-emulsifying adjuvant 160 (SEA160), a squalene-only self-emulsified adjuvant with composition similar to MF59. We compared SE-AS44 and SEA160 co-administered with a recombinant cytomegalovirus (CMV) pentamer antigen, which is a less immunogenic antigen, in vivo to compare the antibody and T-cell responses, in different adjuvanted groups, in C57BL/6 mice.

Keywords

Adjuvants; emulsions; self-emulsification; alpha-tocopherol

Subject

Chemistry and Materials Science, Nanotechnology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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