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  1. Article: Precision Vaccinology Approaches for the Development of Adjuvanted Vaccines Targeted to Distinct Vulnerable Populations.

    Lee, Branden / Nanishi, Etsuro / Levy, Ofer / Dowling, David J

    Pharmaceutics

    2023  Volume 15, Issue 6

    Abstract: Infection persists as one of the leading global causes of morbidity and mortality, with particular burden at the extremes of age and in populations who are immunocompromised or suffer chronic co-morbid diseases. By focusing discovery and innovation ... ...

    Abstract Infection persists as one of the leading global causes of morbidity and mortality, with particular burden at the extremes of age and in populations who are immunocompromised or suffer chronic co-morbid diseases. By focusing discovery and innovation efforts to better understand the phenotypic and mechanistic differences in the immune systems of diverse vulnerable populations, emerging research in precision vaccine discovery and development has explored how to optimize immunizations across the lifespan. Here, we focus on two key elements of precision vaccinology, as applied to epidemic/pandemic response and preparedness, including (a) selecting robust combinations of adjuvants and antigens, and (b) coupling these platforms with appropriate formulation systems. In this context, several considerations exist, including the intended goals of immunization (e.g., achieving immunogenicity versus lessening transmission), reducing the likelihood of adverse reactogenicity, and optimizing the route of administration. Each of these considerations is accompanied by several key challenges. On-going innovation in precision vaccinology will expand and target the arsenal of vaccine components for protection of vulnerable populations.
    Language English
    Publishing date 2023-06-19
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2527217-2
    ISSN 1999-4923
    ISSN 1999-4923
    DOI 10.3390/pharmaceutics15061766
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Bell's palsy and SARS-CoV-2 vaccines-an unfolding story - Authors' reply.

    Ozonoff, Al / Nanishi, Etsuro / Levy, Ofer

    The Lancet. Infectious diseases

    2021  Volume 21, Issue 9, Page(s) 1211–1212

    MeSH term(s) Acyclovir ; Bell Palsy ; COVID-19 ; COVID-19 Vaccines ; Humans ; SARS-CoV-2
    Chemical Substances COVID-19 Vaccines ; Acyclovir (X4HES1O11F)
    Language English
    Publishing date 2021-06-07
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 2061641-7
    ISSN 1474-4457 ; 1473-3099
    ISSN (online) 1474-4457
    ISSN 1473-3099
    DOI 10.1016/S1473-3099(21)00323-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Waning effectiveness of SARS-CoV-2 mRNA vaccines in older adults: a rapid review.

    Nanishi, Etsuro / Levy, Ofer / Ozonoff, Al

    Human vaccines & immunotherapeutics

    2022  Volume 18, Issue 5, Page(s) 2045857

    Abstract: The U.S. Centers for Disease Control and Prevention (CDC) and other health agencies have recently recommended a booster dose of COVID-19 vaccines for specific vulnerable groups including adults 65 years and older. There is limited evidence whether ... ...

    Abstract The U.S. Centers for Disease Control and Prevention (CDC) and other health agencies have recently recommended a booster dose of COVID-19 vaccines for specific vulnerable groups including adults 65 years and older. There is limited evidence whether vaccine effectiveness (VE) in older adults decreases over time, especially against severe COVID-19. We performed a rapid review of published studies available through 4 November 2021 that provide effectiveness data on messenger RNA (mRNA) vaccines approved/licensed in the United States and identified eight eligible studies which evaluated VE in older adults. There is evidence of a decline in VE against both severe acute respiratory syndrome coronavirus 2 infection and severe COVID-19 in older adults among studies which analyzed data up to July-October 2021. Our findings suggest that VE diminishes in older adults, which supports the current recommendation for a booster dose in this population.
    MeSH term(s) Aged ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; RNA, Messenger ; SARS-CoV-2/genetics ; United States ; Vaccines, Synthetic ; mRNA Vaccines
    Chemical Substances COVID-19 Vaccines ; RNA, Messenger ; Vaccines, Synthetic ; mRNA Vaccines
    Language English
    Publishing date 2022-03-03
    Publishing country United States
    Document type Journal Article ; Review ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2664176-8
    ISSN 2164-554X ; 2164-5515
    ISSN (online) 2164-554X
    ISSN 2164-5515
    DOI 10.1080/21645515.2022.2045857
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Bell's palsy and SARS-CoV-2 vaccines.

    Ozonoff, Al / Nanishi, Etsuro / Levy, Ofer

    The Lancet. Infectious diseases

    2021  Volume 21, Issue 4, Page(s) 450–452

    MeSH term(s) Bell Palsy/epidemiology ; Bell Palsy/etiology ; COVID-19/epidemiology ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; Humans ; Influenza Vaccines/adverse effects ; SARS-CoV-2/immunology ; SARS-CoV-2/isolation & purification ; United States/epidemiology ; United States Food and Drug Administration
    Chemical Substances COVID-19 Vaccines ; Influenza Vaccines
    Language English
    Publishing date 2021-02-24
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2061641-7
    ISSN 1474-4457 ; 1473-3099
    ISSN (online) 1474-4457
    ISSN 1473-3099
    DOI 10.1016/S1473-3099(21)00076-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Waning Effectiveness of SARS-CoV-2 mRNA Vaccines in Older Adults: A Rapid Review

    Nanishi, Etsuro / Levy, Ofer / Ozonoff, Al

    medRxiv

    Abstract: The U.S. Centers for Disease Control and Prevention (CDC) and other health agencies have recently recommended a booster dose of COVID-19 vaccines for specific vulnerable groups including adults 65 years and older. There is limited evidence whether ... ...

    Abstract The U.S. Centers for Disease Control and Prevention (CDC) and other health agencies have recently recommended a booster dose of COVID-19 vaccines for specific vulnerable groups including adults 65 years and older. There is limited evidence whether vaccine effectiveness in older adults decreases over time, especially against severe COVID-19. We performed a rapid review of published studies available through 04 November 2021 that provide effectiveness data on mRNA vaccines approved/licensed in the United States and identified eight eligible studies which evaluated vaccine effectiveness in older adults. There is evidence of a decline in vaccine effectiveness against both SARS-CoV-2 infection and severe COVID-19 in older adults among studies which analyzed data up to July-October 2021. Our findings suggest that vaccine effectiveness diminishes in older adults, which supports the current recommendation for a booster dose in this population.
    Keywords covid19
    Language English
    Publishing date 2022-01-16
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2022.01.15.22269364
    Database COVID19

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  6. Article ; Online: Precision Vaccine Development: Cues From Natural Immunity.

    Barman, Soumik / Soni, Dheeraj / Brook, Byron / Nanishi, Etsuro / Dowling, David J

    Frontiers in immunology

    2022  Volume 12, Page(s) 662218

    Abstract: Traditional vaccine development against infectious diseases has been guided by the overarching aim to generate efficacious vaccines normally indicated by an antibody and/or cellular response that correlates with protection. However, this approach has ... ...

    Abstract Traditional vaccine development against infectious diseases has been guided by the overarching aim to generate efficacious vaccines normally indicated by an antibody and/or cellular response that correlates with protection. However, this approach has been shown to be only a partially effective measure, since vaccine- and pathogen-specific immunity may not perfectly overlap. Thus, some vaccine development strategies, normally focused on targeted generation of both antigen specific antibody and T cell responses, resulting in a long-lived heterogenous and stable pool of memory lymphocytes, may benefit from better mimicking the immune response of a natural infection. However, challenges to achieving this goal remain unattended, due to gaps in our understanding of human immunity and full elucidation of infectious pathogenesis. In this review, we describe recent advances in the development of effective vaccines, focusing on how understanding the differences in the immunizing and non-immunizing immune responses to natural infections and corresponding shifts in immune ontogeny are crucial to inform the next generation of infectious disease vaccines.
    MeSH term(s) Cues ; Humans ; Immunity, Innate ; T-Lymphocytes ; Vaccines
    Chemical Substances Vaccines
    Language English
    Publishing date 2022-02-10
    Publishing country Switzerland
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 2606827-8
    ISSN 1664-3224 ; 1664-3224
    ISSN (online) 1664-3224
    ISSN 1664-3224
    DOI 10.3389/fimmu.2021.662218
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Precision Vaccine Adjuvants for Older Adults: A Scoping Review.

    Nanishi, Etsuro / Angelidou, Asimenia / Rotman, Chloe / Dowling, David J / Levy, Ofer / Ozonoff, Al

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2022  Volume 75, Issue Supplement_1, Page(s) S72–S80

    Abstract: Older adults, defined as those ≥60 years of age, are a growing population vulnerable to infections including severe acute respiratory syndrome coronavirus 2. Although immunization is a key to protecting this population, immunosenescence can impair ... ...

    Abstract Older adults, defined as those ≥60 years of age, are a growing population vulnerable to infections including severe acute respiratory syndrome coronavirus 2. Although immunization is a key to protecting this population, immunosenescence can impair responses to vaccines. Adjuvants can increase the immunogenicity of vaccine antigens but have not been systematically compared in older adults. We conducted a scoping review to assess the comparative effectiveness of adjuvants in aged populations. Adjuvants AS01, MF59, AS03, and CpG-oligodeoxynucleotide, included in licensed vaccines, are effective in older human adults. A growing menu of investigational adjuvants, such as Matrix-M and CpG plus alum, showed promising results in early phase clinical trials and preclinical studies. Most studies assessed only 1 or 2 adjuvants and no study has directly compared >3 adjuvants among older adults. Enhanced preclinical approaches enabling direct comparison of multiple adjuvants including human in vitro modeling and age-specific animal models may derisk and accelerate vaccine development for older adults.
    MeSH term(s) Adjuvants, Immunologic ; Adjuvants, Vaccine ; Aged ; Animals ; COVID-19/prevention & control ; Humans ; Vaccination ; Vaccines
    Chemical Substances Adjuvants, Immunologic ; Adjuvants, Vaccine ; Vaccines
    Language English
    Publishing date 2022-04-22
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciac302
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Toward precision adjuvants: optimizing science and safety.

    Nanishi, Etsuro / Dowling, David J / Levy, Ofer

    Current opinion in pediatrics

    2019  Volume 32, Issue 1, Page(s) 125–138

    Abstract: Purpose of review: The gradual replacement of inactivated whole cell and live attenuated vaccines with subunit vaccines has generally reduced reactogenicity but in many cases also immunogenicity. Although only used when necessary, adjuvants can be key ... ...

    Abstract Purpose of review: The gradual replacement of inactivated whole cell and live attenuated vaccines with subunit vaccines has generally reduced reactogenicity but in many cases also immunogenicity. Although only used when necessary, adjuvants can be key to vaccine dose/antigen-sparing, broadening immune responses to variable antigens, and enhancing immunogenicity in vulnerable populations with distinct immunity. Licensed vaccines contain an increasing variety of adjuvants, with a growing pipeline of adjuvanted vaccines under development.
    Recent findings: Most adjuvants, including Alum, Toll-like receptor agonists and oil-in-water emulsions, activate innate immunity thereby altering the quantity and quality of an adaptive immune response. Adjuvants activate leukocytes, and induce mediators (e.g., cytokines, chemokines, and prostaglandin-E2) some of which are biomarkers for reactogenicity, that is, induction of local/systemic side effects. Although there have been safety concerns regarding a hypothetical risk of adjuvants inducing auto-immunity, such associations have not been established. As immune responses vary by population (e.g., age and sex), adjuvant research now incorporates principles of precision medicine. Innovations in adjuvant research include use of human in vitro models, immuno-engineering, novel delivery systems, and systems biology to identify biomarkers of safety and adjuvanticity.
    Summary: Adjuvants enhance vaccine immunogenicity and can be associated with reactogenicity. Novel multidisciplinary approaches hold promise to accelerate and de-risk targeted adjuvant discovery and development. VIDEO ABSTRACT: http://links.lww.com/MOP/A53.
    MeSH term(s) Adaptive Immunity/drug effects ; Adaptive Immunity/immunology ; Adjuvants, Immunologic/pharmacology ; Adjuvants, Immunologic/standards ; Biomarkers/blood ; Drug Delivery Systems ; Humans ; Immunity, Innate/drug effects ; Immunity, Innate/immunology ; Immunogenicity, Vaccine/drug effects ; Immunogenicity, Vaccine/immunology ; Precision Medicine ; Treatment Outcome ; Vaccines/immunology ; Vaccines/therapeutic use
    Chemical Substances Adjuvants, Immunologic ; Biomarkers ; Vaccines
    Language English
    Publishing date 2019-12-12
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 1049374-8
    ISSN 1531-698X ; 1040-8703
    ISSN (online) 1531-698X
    ISSN 1040-8703
    DOI 10.1097/MOP.0000000000000868
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: The immunoregulatory function of peripheral blood CD71

    Kanemasa, Hikaru / Ishimura, Masataka / Eguchi, Katsuhide / Tanaka, Tamami / Nanishi, Etsuro / Shiraishi, Akira / Goto, Motohiro / Motomura, Yoshitomo / Ohga, Shouichi

    Scientific reports

    2021  Volume 11, Issue 1, Page(s) 14396

    Abstract: ... ...

    Abstract CD71
    MeSH term(s) Antigens, CD ; Arthritis, Juvenile ; C-Reactive Protein/metabolism ; Child ; Cytokines/metabolism ; Humans ; Infant, Newborn ; Leukocytes, Mononuclear ; Receptors, Transferrin
    Chemical Substances Antigens, CD ; CD71 antigen ; Cytokines ; Receptors, Transferrin ; C-Reactive Protein (9007-41-4)
    Language English
    Publishing date 2021-07-13
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-021-93831-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Precision Vaccines: Lessons Learned From the Coronavirus Pandemic.

    Angelidou, Asimenia / Evans, Jay / Idoko, Olubukola / Levy, Ofer / Lewis, Nicole Pignatiello / Nanishi, Etsuro / Odumade, Oludare A / Ozonoff, Al / Plotkin, Stanley / Sherman, Amy C / van Haren, Simon D / Weitzman, Elissa R

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2022  Volume 75, Issue Suppl 1, Page(s) S1

    MeSH term(s) COVID-19/prevention & control ; Humans ; Pandemics/prevention & control ; SARS-CoV-2 ; Vaccines
    Chemical Substances Vaccines
    Language English
    Publishing date 2022-04-19
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1093/cid/ciac300
    Database MEDical Literature Analysis and Retrieval System OnLINE

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