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  1. Artikel ; Online: Author Correction: "World in motion" - emulsion adjuvants rising to meet the pandemic challenges.

    O'Hagan, Derek T / van der Most, Robbert / Lodaya, Rushit N / Coccia, Margherita / Lofano, Giuseppe

    NPJ vaccines

    2023  Band 8, Heft 1, Seite(n) 7

    Sprache Englisch
    Erscheinungsdatum 2023-02-02
    Erscheinungsland England
    Dokumenttyp Published Erratum
    ISSN 2059-0105
    ISSN (online) 2059-0105
    DOI 10.1038/s41541-023-00601-5
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: The continued advance of vaccine adjuvants - 'we can work it out'.

    O'Hagan, Derek T / Lodaya, Rushit N / Lofano, Giuseppe

    Seminars in immunology

    2020  Band 50, Seite(n) 101426

    Abstract: In the last decade there have been some significant advances in vaccine adjuvants, particularly in relation to their inclusion in licensed products. This was proceeded by several decades in which such advances were very scarce, or entirely absent, but ... ...

    Abstract In the last decade there have been some significant advances in vaccine adjuvants, particularly in relation to their inclusion in licensed products. This was proceeded by several decades in which such advances were very scarce, or entirely absent, but several novel adjuvants have now been included in licensed products, including in the US. These advances have relied upon several key technological insights that have emerged in this time period, which have finally allowed an in depth understanding of how adjuvants work. These advances include developments in systems biology approaches which allow the hypotheses first advanced in pre-clinical studies to be critically evaluated in human studies. This review highlights these recent advances, both in relation to the adjuvants themselves, but also the technologies that have enabled their successes. Moreover, we critically appraise what will come next, both in terms of new adjuvant molecules, and the technologies needed to allow them to succeed. We confidently predict that additional adjuvants will emerge in the coming years that will reach approval in licensed products, but that the components might differ significantly from those which are currently used. Gradually, the natural products that were originally used to build adjuvants, since they were readily available at the time of initial development, will come to be replaced by synthetic or biosynthetic materials, with more appealing attributes, including more reliable and robust supply, along with reduced heterogeneity. The recent advance in vaccine adjuvants is timely, given the need to create novel vaccines to deal with the COVID-19 pandemic. Although, we must ensure that the rigorous safety evaluations that allowed the current adjuvants to advance are not 'short-changed' in the push for new vaccines to meet the global challenge as quickly as possible, we must not jeopardize what we have achieved, by pushing less established technologies too quickly, if the data does not fully support it.
    Mesh-Begriff(e) Adjuvants, Immunologic/therapeutic use ; Alum Compounds/pharmacology ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19 Vaccines/immunology ; COVID-19 Vaccines/therapeutic use ; Humans ; SARS-CoV-2/immunology ; Systems Biology ; Vaccinology/methods
    Chemische Substanzen Adjuvants, Immunologic ; Alum Compounds ; COVID-19 Vaccines ; aluminum sulfate (34S289N54E)
    Sprache Englisch
    Erscheinungsdatum 2020-11-27
    Erscheinungsland England
    Dokumenttyp Journal Article ; Review
    ZDB-ID 1018141-6
    ISSN 1096-3618 ; 1044-5323
    ISSN (online) 1096-3618
    ISSN 1044-5323
    DOI 10.1016/j.smim.2020.101426
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel: 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.

    Lodaya, Rushit N / Kanitkar, Amey P / Ashraf, Asma / Bamba, Douty / Amiji, Mansoor M / O'Hagan, Derek T

    Pharmaceutics

    2023  Band 15, Heft 1

    Abstract: The development of new vaccine adjuvants represents a key approach to improvingi the immune responses to recombinant vaccine antigens. Emulsion adjuvants, such as AS03 and MF59, in combination with influenza vaccines, have allowed antigen dose sparing, ... ...

    Abstract The development of new vaccine adjuvants represents a key approach to improvingi the immune responses to recombinant vaccine antigens. Emulsion adjuvants, such as AS03 and MF59, in combination with influenza vaccines, have allowed antigen dose sparing, greater breadth of responses and fewer immunizations. It has been demonstrated previously that emulsion adjuvants can be prepared using a simple, low-shear process of self-emulsification (SE). The role of alpha tocopherol as an immune potentiator in emulsion adjuvants is clear from the success of AS03 in pandemic responses, both to influenza and COVID-19. Although it was a significant formulation challenge to include alpha tocopherol in an emulsion prepared by a low-shear process, the resultant self-emulsifying adjuvant system (SE-AS) showed a comparable effect to the established AS03 when used with a quadrivalent influenza vaccine (QIV). In this paper, we first optimized the SE-AS with alpha tocopherol to create SE-AS44, which allowed the emulsion to be sterile-filtered. Then, we compared the in vitro cell activation cytokine profile of SE-AS44 with the self-emulsifying adjuvant 160 (SEA160), a squalene-only adjuvant. In addition, we evaluated SE-AS44 and SEA160 competitively, in combination with a recombinant cytomegalovirus (CMV) pentamer antigen mouse.
    Sprache Englisch
    Erscheinungsdatum 2023-01-10
    Erscheinungsland Switzerland
    Dokumenttyp Journal Article
    ZDB-ID 2527217-2
    ISSN 1999-4923
    ISSN 1999-4923
    DOI 10.3390/pharmaceutics15010238
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  4. Artikel ; Online: "World in motion" - emulsion adjuvants rising to meet the pandemic challenges.

    O'Hagan, Derek T / van der Most, Robbert / Lodaya, Rushit N / Coccia, Margherita / Lofano, Giuseppe

    NPJ vaccines

    2021  Band 6, Heft 1, Seite(n) 158

    Abstract: Emulsion adjuvants such as MF59 and AS03 have been used for more than two decades as key components of licensed vaccines, with over 100 million doses administered to diverse populations in more than 30 countries. Substantial clinical experience of ... ...

    Abstract Emulsion adjuvants such as MF59 and AS03 have been used for more than two decades as key components of licensed vaccines, with over 100 million doses administered to diverse populations in more than 30 countries. Substantial clinical experience of effectiveness and a well-established safety profile, along with the ease of manufacturing have established emulsion adjuvants as one of the leading platforms for the development of pandemic vaccines. Emulsion adjuvants allow for antigen dose sparing, more rapid immune responses, and enhanced quality and quantity of adaptive immune responses. The mechanisms of enhancement of immune responses are well defined and typically characterized by the creation of an "immunocompetent environment" at the site of injection, followed by the induction of strong and long-lasting germinal center responses in the draining lymph nodes. As a result, emulsion adjuvants induce distinct immunological responses, with a mixed Th1/Th2 T cell response, long-lived plasma cells, an expanded repertoire of memory B cells, and high titers of cross-neutralizing polyfunctional antibodies against viral variants. Because of these various properties, emulsion adjuvants were included in pandemic influenza vaccines deployed during the 2009 H1N1 influenza pandemic, are still included in seasonal influenza vaccines, and are currently at the forefront of the development of vaccines against emerging SARS-CoV-2 pandemic variants. Here, we comprehensively review emulsion adjuvants, discuss their mechanism of action, and highlight their profile as a benchmark for the development of additional vaccine adjuvants and as a valuable tool to allow further investigations of the general principles of human immunity.
    Sprache Englisch
    Erscheinungsdatum 2021-12-21
    Erscheinungsland England
    Dokumenttyp Journal Article ; Review
    ISSN 2059-0105
    ISSN (online) 2059-0105
    DOI 10.1038/s41541-021-00418-0
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  5. Artikel: Formulation Design, Optimization and In Vivo Evaluations of an α-Tocopherol-Containing Self-Emulsified Adjuvant System using Inactivated Influenza Vaccine

    Lodaya, Rushit N / Kanitkar, Amey P / Friedrich, Kristian / Henson, Dawn / Yamagata, Ryan / Nuti, Sandra / Mallett, Corey P / Bertholet, Sylvie / Amiji, Mansoor M / O’Hagan, Derek T

    Journal of controlled release. 2019 Dec. 28, v. 316

    2019  

    Abstract: α-Tocopherol has been used as an immune supplement in humans, as an emulsion adjuvant component in several veterinary vaccines as well as an immunomodulatory component of AS03, an emulsion adjuvant that was used in an H1N1 pandemic vaccine (Pandemrix). ... ...

    Abstract α-Tocopherol has been used as an immune supplement in humans, as an emulsion adjuvant component in several veterinary vaccines as well as an immunomodulatory component of AS03, an emulsion adjuvant that was used in an H1N1 pandemic vaccine (Pandemrix). AS03 is manufactured using microfluidization and high-pressure homogenization. Such high energy and complex manufacturing processes make it difficult and expensive to produce emulsion adjuvants on a large scale, especially in developing countries. In this study we have explored simpler, comparatively inexpensive methods, to formulate emulsion adjuvants containing α-tocopherol, that have the potential to be made in any well-established scale-up facility. This might facilitate producing and stock-piling adjuvant doses and therefore aide in pandemic preparedness. We used design of experiment as a tool to explore incorporating α-tocopherol into self-emulsified systems containing squalene oil and polysorbate 80. We created novel self-emulsified adjuvant systems (SE-AS) and evaluated their potency in vivo in BALB/c mice with inactivated quadrivalent influenza vaccine (QIV) and tested the cellular and humoral immune responses against the four vaccine strains.
    Schlagwörter adjuvants ; alpha-tocopherol ; developing countries ; emulsions ; homogenization ; humans ; humoral immunity ; in vivo studies ; influenza vaccines ; manufacturing ; oils ; pandemic ; polysorbates ; squalene
    Sprache Englisch
    Erscheinungsverlauf 2019-1228
    Umfang p. 12-21.
    Erscheinungsort Elsevier B.V.
    Dokumenttyp Artikel
    ZDB-ID 632533-6
    ISSN 1873-4995 ; 0168-3659
    ISSN (online) 1873-4995
    ISSN 0168-3659
    DOI 10.1016/j.jconrel.2019.10.042
    Datenquelle NAL Katalog (AGRICOLA)

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  6. Artikel ; Online: Stable Nanoemulsions for the Delivery of Small Molecule Immune Potentiators.

    Lodaya, Rushit N / Brito, Luis A / Wu, Tom Y H / Miller, Andrew T / Otten, Gillis R / Singh, Manmohan / O'Hagan, Derek T

    Journal of pharmaceutical sciences

    2018  Band 107, Heft 9, Seite(n) 2310–2314

    Abstract: Adjuvants are required to enhance immune responses to typically poorly immunogenic recombinant antigens. Toll-like receptor agonists (TLRa) have been widely evaluated as adjuvants because they activate the innate immune system. Currently, licensed ... ...

    Abstract Adjuvants are required to enhance immune responses to typically poorly immunogenic recombinant antigens. Toll-like receptor agonists (TLRa) have been widely evaluated as adjuvants because they activate the innate immune system. Currently, licensed vaccines adjuvanted with TLRa include the TLR4 agonist monophosphoryl lipid, while additional TLRa are in clinical development. Unfortunately, naturally derived TLRa are often complex and heterogeneous entities, which brings formulation challenges. Consequently, the use of synthetic small-molecule TLRa has significant advantages because they are well-defined discrete molecules, which can be chemically modified to modulate their physicochemical properties. We previously described the discovery of a family of TLR7 agonists based on a benzonaphthyridine scaffold. In addition, we described how Alum could be used to deliver these synthetic TLRa. An alternative adjuvant approach with enhanced potency over Alum are squalene containing oil-in-water emulsions, which have been included in licensed influenza vaccines, including Fluad (MF59 adjuvanted) and Pandemrix (AS03 adjuvanted). Here, we describe how to enable the co-delivery of a TLR7 agonist in a squalene-based oil-in-water emulsion, for adjuvant evaluation.
    Mesh-Begriff(e) Animals ; Antigens, Bacterial/administration & dosage ; Antigens, Bacterial/immunology ; Drug Delivery Systems/methods ; Drug Stability ; Emulsions/administration & dosage ; Female ; Immunity, Cellular/drug effects ; Immunity, Cellular/immunology ; Mice ; Mice, Inbred BALB C ; Nanocapsules/administration & dosage
    Chemische Substanzen Antigens, Bacterial ; Emulsions ; Nanocapsules
    Sprache Englisch
    Erscheinungsdatum 2018-06-05
    Erscheinungsland United States
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 3151-3
    ISSN 1520-6017 ; 0022-3549
    ISSN (online) 1520-6017
    ISSN 0022-3549
    DOI 10.1016/j.xphs.2018.05.012
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  7. Artikel ; Online: Formulation Design, Optimization and In Vivo Evaluations of an α-Tocopherol-Containing Self-Emulsified Adjuvant System using Inactivated Influenza Vaccine.

    Lodaya, Rushit N / Kanitkar, Amey P / Friedrich, Kristian / Henson, Dawn / Yamagata, Ryan / Nuti, Sandra / Mallett, Corey P / Bertholet, Sylvie / Amiji, Mansoor M / O'Hagan, Derek T

    Journal of controlled release : official journal of the Controlled Release Society

    2019  Band 316, Seite(n) 12–21

    Abstract: α-Tocopherol has been used as an immune supplement in humans, as an emulsion adjuvant component in several veterinary vaccines as well as an immunomodulatory component of AS03, an emulsion adjuvant that was used in an H1N1 pandemic vaccine (Pandemrix). ... ...

    Abstract α-Tocopherol has been used as an immune supplement in humans, as an emulsion adjuvant component in several veterinary vaccines as well as an immunomodulatory component of AS03, an emulsion adjuvant that was used in an H1N1 pandemic vaccine (Pandemrix). AS03 is manufactured using microfluidization and high-pressure homogenization. Such high energy and complex manufacturing processes make it difficult and expensive to produce emulsion adjuvants on a large scale, especially in developing countries. In this study we have explored simpler, comparatively inexpensive methods, to formulate emulsion adjuvants containing α-tocopherol, that have the potential to be made in any well-established scale-up facility. This might facilitate producing and stock-piling adjuvant doses and therefore aide in pandemic preparedness. We used design of experiment as a tool to explore incorporating α-tocopherol into self-emulsified systems containing squalene oil and polysorbate 80. We created novel self-emulsified adjuvant systems (SE-AS) and evaluated their potency in vivo in BALB/c mice with inactivated quadrivalent influenza vaccine (QIV) and tested the cellular and humoral immune responses against the four vaccine strains.
    Mesh-Begriff(e) Adjuvants, Immunologic/administration & dosage ; Animals ; Emulsions ; Female ; Humans ; Influenza A Virus, H1N1 Subtype/immunology ; Influenza Vaccines/administration & dosage ; Influenza Vaccines/immunology ; Influenza, Human/immunology ; Influenza, Human/prevention & control ; Mice ; Mice, Inbred BALB C ; Polysorbates/chemistry ; Squalene/chemistry ; Vaccines, Inactivated/administration & dosage ; Vaccines, Inactivated/immunology ; alpha-Tocopherol/administration & dosage ; alpha-Tocopherol/immunology
    Chemische Substanzen Adjuvants, Immunologic ; Emulsions ; Influenza Vaccines ; Polysorbates ; Vaccines, Inactivated ; Squalene (7QWM220FJH) ; alpha-Tocopherol (H4N855PNZ1)
    Sprache Englisch
    Erscheinungsdatum 2019-10-31
    Erscheinungsland Netherlands
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 632533-6
    ISSN 1873-4995 ; 0168-3659
    ISSN (online) 1873-4995
    ISSN 0168-3659
    DOI 10.1016/j.jconrel.2019.10.042
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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