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  1. Article ; Online: Thrombotic Thrombocytopenia after Ad26.COV2.S Vaccination - Response from the Manufacturer.

    Sadoff, Jerald / Davis, Kourtney / Douoguih, Macaya

    The New England journal of medicine

    2021  Volume 384, Issue 20, Page(s) 1965–1966

    MeSH term(s) Antibodies, Neutralizing ; Humans ; Thrombocytopenia ; Vaccination
    Chemical Substances Antibodies, Neutralizing
    Language English
    Publishing date 2021-04-16
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2106075
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  2. Article ; Online: Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. Reply.

    Vandebosch, An / Sadoff, Jerald / Douoguih, Macaya

    The New England journal of medicine

    2021  Volume 385, Issue 3, Page(s) 288

    MeSH term(s) Antibodies, Neutralizing ; COVID-19 ; COVID-19 Vaccines ; Humans ; Immunogenicity, Vaccine ; SARS-CoV-2
    Chemical Substances Antibodies, Neutralizing ; COVID-19 Vaccines
    Language English
    Publishing date 2021-06-09
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2107809
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  3. Article ; Online: ChAdOx1 nCoV-19 Vaccine Efficacy against the B.1.351 Variant.

    Struyf, Frank / Sadoff, Jerald / Douoguih, Macaya

    The New England journal of medicine

    2021  Volume 385, Issue 6, Page(s) 571

    MeSH term(s) COVID-19 ; COVID-19 Vaccines ; Humans ; SARS-CoV-2 ; Vaccines
    Chemical Substances COVID-19 Vaccines ; Vaccines ; ChAdOx1 COVID-19 vaccine (B5S3K2V0G8)
    Language English
    Publishing date 2021-07-21
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2110093
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  4. Article ; Online: Absolute quantitation of binding antibodies from clinical samples.

    Tang, Chan / Verwilligen, Annemiek / Sadoff, Jerald / Brandenburg, Boerries / Sneekes-Vriese, Eveline / van den Kerkhof, Tom / Dillen, Lieve / Rutten, Lucy / Juraszek, Jarek / Callewaert, Katleen / Janssen, Sarah / Huizingh, Jeroen / Euler, Zelda / Schilperoord, Tom / Verhemeldonck, Marc / Langedijk, Johannes P M / Hendriks, Jenny / Stieh, Daniel J

    NPJ vaccines

    2024  Volume 9, Issue 1, Page(s) 8

    Abstract: The quantitation of antibody responses is a critical requirement for the successful development of vaccines and therapeutics that often relies on the use of standardized reference materials to determine relative quantities within biological samples. The ... ...

    Abstract The quantitation of antibody responses is a critical requirement for the successful development of vaccines and therapeutics that often relies on the use of standardized reference materials to determine relative quantities within biological samples. The validity of comparing responses across assays using arbitrarily defined reference values is therefore limited. We developed a generalizable method known as MASCALE (Mass Spectrometry Enabled Conversion to Absolute Levels of ELISA Antibodies) for absolute quantitation of antibodies by calibrating ELISA reference sera using mass spectrometry. Levels of proteotypic peptides served as a proxy for human IgG, allowing the conversion of responses from arbitrary values to absolute amounts. Applications include comparison of binding assays at two separate laboratories and evaluation of cross-clade magnitude-breadth responses induced by an investigational HIV-1 vaccine regimen. MASCALE addresses current challenges in the interpretation of immune responses in clinical trials and expands current options available to make suitable comparisons across different settings.
    Language English
    Publishing date 2024-01-06
    Publishing country England
    Document type Journal Article
    ISSN 2059-0105
    ISSN (online) 2059-0105
    DOI 10.1038/s41541-023-00793-w
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Mechanistic modeling projections of antibody persistence after homologous booster regimens of COVID-19 vaccine Ad26.COV2.S in humans.

    Dari, Anna / Jacqmin, Philippe / Iwaki, Yuki / Neyens, Martine / Le Gars, Mathieu / Sadoff, Jerald / Hardt, Karin / Ruiz-Guiñazú, Javier / Pérez-Ruixo, Juan José

    CPT: pharmacometrics & systems pharmacology

    2023  Volume 12, Issue 10, Page(s) 1485–1498

    Abstract: Mechanistic model-based simulations can be deployed to project the persistence of humoral immune response following vaccination. We used this approach to project the antibody persistence through 24 months from the data pooled across five clinical trials ... ...

    Abstract Mechanistic model-based simulations can be deployed to project the persistence of humoral immune response following vaccination. We used this approach to project the antibody persistence through 24 months from the data pooled across five clinical trials in severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)-seronegative participants following vaccination with Ad26.COV2.S (5 × 10
    MeSH term(s) Male ; Humans ; Female ; Ad26COVS1 ; COVID-19 Vaccines ; COVID-19/prevention & control ; SARS-CoV-2 ; Antibodies, Neutralizing
    Chemical Substances Ad26COVS1 (JT2NS6183B) ; COVID-19 Vaccines ; Antibodies, Neutralizing
    Language English
    Publishing date 2023-09-15
    Publishing country United States
    Document type Journal Article ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 2697010-7
    ISSN 2163-8306 ; 2163-8306
    ISSN (online) 2163-8306
    ISSN 2163-8306
    DOI 10.1002/psp4.13025
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: B cell somatic hypermutation following COVID-19 vaccination with Ad26.COV2.S.

    Jacob-Dolan, Catherine / Lifton, Michelle / Powers, Olivia C / Miller, Jessica / Hachmann, Nicole P / Vu, Mya / Surve, Nehalee / Mazurek, Camille R / Fisher, Jana L / Rodrigues, Stefanie / Patio, Robert C / Anand, Trisha / Le Gars, Mathieu / Sadoff, Jerald / Schmidt, Aaron G / Barouch, Dan H

    iScience

    2024  Volume 27, Issue 5, Page(s) 109716

    Abstract: The viral vector-based COVID-19 vaccine Ad26.COV2.S has been recommended by the WHO since 2021 and has been administered to over 200 million people. Prior studies have shown that Ad26.COV2.S induces durable neutralizing antibodies (NAbs) that increase in ...

    Abstract The viral vector-based COVID-19 vaccine Ad26.COV2.S has been recommended by the WHO since 2021 and has been administered to over 200 million people. Prior studies have shown that Ad26.COV2.S induces durable neutralizing antibodies (NAbs) that increase in coverage of variants over time, even in the absence of boosting or infection. Here, we studied humoral responses following Ad26.COV2.S vaccination in individuals enrolled in the initial Phase 1/2a trial of Ad26.COV2.S in 2020. Through 8 months post vaccination, serum NAb responses increased to variants, including B.1.351 (Beta) and B.1.617.2 (Delta), without additional boosting or infection. The level of somatic hypermutation, measured by nucleotide changes in the VDJ region of the heavy and light antibody chains, increased in Spike-specific B cells. Highly mutated mAbs from these sequences neutralized more SARS-CoV-2 variants than less mutated comparators. These findings suggest that the increase in NAb breadth over time following Ad26.COV2.S vaccination is mediated by affinity maturation.
    Language English
    Publishing date 2024-04-09
    Publishing country United States
    Document type Journal Article
    ISSN 2589-0042
    ISSN (online) 2589-0042
    DOI 10.1016/j.isci.2024.109716
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  7. Book ; Conference proceedings: Symposium on Pseudomonas Aeruginosa Infections

    Sadoff, Jerald C.

    a symp. held in Washington, D.C., Dec. 6 - 7, 1979

    (Reviews of infectious diseases ; 5, Suppl. 5)

    1983  

    Event/congress Symposium on Pseudomonas Aeruginosa Infections (1979, WashingtonDC)
    Author's details guest eds.: Jerald C. Sadoff
    Series title Reviews of infectious diseases ; 5, Suppl. 5
    Collection
    Keywords Pseudomonas Infections / congresses
    Size S. S833 - S1004 : Ill., graph. Darst.
    Publisher Univ. of Chicago Pr
    Publishing place Chicago, Ill
    Publishing country United States
    Document type Book ; Conference proceedings
    HBZ-ID HT002127906
    Database Catalogue ZB MED Medicine, Health

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    Shelf markLoan statusLocation
    Zs A 1505 -5,Suppl.5- verfügbar in Königswinter Königswinter

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  8. Article ; Online: Immunogenicity and efficacy of Ad26.COV2.S: An adenoviral vector-based COVID-19 vaccine.

    Le Gars, Mathieu / Hendriks, Jenny / Sadoff, Jerald / Ryser, Martin / Struyf, Frank / Douoguih, Macaya / Schuitemaker, Hanneke

    Immunological reviews

    2022  Volume 310, Issue 1, Page(s) 47–60

    Abstract: Since its emergence in late 2019, the coronavirus disease 2019 (COVID-19) pandemic has caused substantial morbidity and mortality. Despite the availability of efficacious vaccines, new variants with reduced sensitivity to vaccine-induced protection are a ...

    Abstract Since its emergence in late 2019, the coronavirus disease 2019 (COVID-19) pandemic has caused substantial morbidity and mortality. Despite the availability of efficacious vaccines, new variants with reduced sensitivity to vaccine-induced protection are a troubling new reality. The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding a full-length, membrane-bound severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation. This review discusses the immunogenicity and efficacy of Ad26.COV2.S as a single-dose primary vaccination and as a homologous or heterologous booster vaccination. Ad26.COV2.S elicits broad humoral and cellular immune responses, which are associated with protective efficacy/effectiveness against SARS-CoV-2 infection, moderate to severe/critical COVID-19, and COVID-19-related hospitalization and death, including against emerging SARS-CoV-2 variants. The humoral immune responses elicited by Ad26.COV2.S vaccination are durable, continue to increase for at least 2-3 months postvaccination, and involve a range of functional antibodies. Ad26.COV2.S given as a heterologous booster to mRNA vaccine-primed individuals markedly increases humoral and cellular immune responses. The use of Ad26.COV2.S as primary vaccination and as part of booster regimens is supporting the ongoing efforts to control and mitigate the COVID-19 pandemic.
    MeSH term(s) Ad26COVS1 ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; Pandemics/prevention & control ; SARS-CoV-2 ; Vaccines, Synthetic ; mRNA Vaccines
    Chemical Substances Ad26COVS1 (JT2NS6183B) ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines ; Vaccines, Synthetic ; mRNA Vaccines
    Language English
    Publishing date 2022-06-11
    Publishing country England
    Document type Journal Article ; Review ; Research Support, N.I.H., Extramural
    ZDB-ID 391796-4
    ISSN 1600-065X ; 0105-2896
    ISSN (online) 1600-065X
    ISSN 0105-2896
    DOI 10.1111/imr.13088
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Vaccine-induced antibody Fc-effector functions in humans immunized with a combination Ad26.RSV.preF/RSV preF protein vaccine.

    Bartsch, Yannic C / Cizmeci, Deniz / Yuan, Dansu / Mehta, Nickita / Tolboom, Jeroen / De Paepe, Els / van Heesbeen, Roy / Sadoff, Jerald / Comeaux, Christy A / Heijnen, Esther / Callendret, Benoit / Alter, Galit / Bastian, Arangassery Rosemary

    Journal of virology

    2023  Volume 97, Issue 11, Page(s) e0077123

    Abstract: Importance: Respiratory syncytial virus (RSV) can cause serious illness in older adults (i.e., those aged ≥60 years). Because options for RSV prophylaxis and treatment are limited, the prevention of RSV-mediated illness in older adults remains an ... ...

    Abstract Importance: Respiratory syncytial virus (RSV) can cause serious illness in older adults (i.e., those aged ≥60 years). Because options for RSV prophylaxis and treatment are limited, the prevention of RSV-mediated illness in older adults remains an important unmet medical need. Data from prior studies suggest that Fc-effector functions are important for protection against RSV infection. In this work, we show that the investigational Ad26.RSV.preF/RSV preF protein vaccine induced Fc-effector functional immune responses in adults aged ≥60 years who were enrolled in a phase 1/2a regimen selection study of Ad26.RSV.preF/RSV preF protein. These results demonstrate the breadth of the immune responses induced by the Ad26.RSV.preF/RSV preF protein vaccine.
    MeSH term(s) Aged ; Humans ; Antibodies, Neutralizing ; Antibodies, Viral ; Immunoglobulin Fc Fragments ; Respiratory Syncytial Virus Infections/prevention & control ; Respiratory Syncytial Virus Vaccines/immunology ; Respiratory Syncytial Virus, Human ; Viral Fusion Proteins/immunology
    Chemical Substances Antibodies, Neutralizing ; Antibodies, Viral ; Immunoglobulin Fc Fragments ; Respiratory Syncytial Virus Vaccines ; Viral Fusion Proteins
    Language English
    Publishing date 2023-10-30
    Publishing country United States
    Document type Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article
    ZDB-ID 80174-4
    ISSN 1098-5514 ; 0022-538X
    ISSN (online) 1098-5514
    ISSN 0022-538X
    DOI 10.1128/jvi.00771-23
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-Based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study.

    Comeaux, Christy A / Bart, Stephan / Bastian, Arangassery Rosemary / Klyashtornyy, Vladislav / De Paepe, Els / Omoruyi, Edmund / van der Fits, Leslie / van Heesbeen, Roy / Heijnen, Esther / Callendret, Benoit / Sadoff, Jerald

    The Journal of infectious diseases

    2023  Volume 229, Issue 1, Page(s) 19–29

    Abstract: Background: Ad26.RSV.preF is an adenovirus serotype 26 vector-based respiratory syncytial virus (RSV) vaccine encoding a prefusion conformation-stabilized RSV fusion protein (preF) that demonstrated robust humoral and cellular immunogenicity and showed ... ...

    Abstract Background: Ad26.RSV.preF is an adenovirus serotype 26 vector-based respiratory syncytial virus (RSV) vaccine encoding a prefusion conformation-stabilized RSV fusion protein (preF) that demonstrated robust humoral and cellular immunogenicity and showed promising efficacy in a human challenge study in younger adults. Addition of recombinant RSV preF protein might enhance RSV-specific humoral immune responses, especially in older populations.
    Methods: This randomized, double-blind, placebo-controlled, phase 1/2a study compared the safety and immunogenicity of Ad26.RSV.preF alone and varying doses of Ad26.RSV.preF-RSV preF protein combinations in adults aged ≥60 years. This report includes data from cohort 1 (initial safety, n = 64) and cohort 2 (regimen selection, n = 288). Primary immunogenicity and safety analyses were performed 28 days postvaccination (cohort 2) for regimen selection.
    Results: All vaccine regimens were well tolerated, with similar reactogenicity profiles among them. Combination regimens induced greater humoral immune responses (virus-neutralizing and preF-specific binding antibodies) and similar cellular ones (RSV-F-specific T cells) as compared with Ad26.RSV.preF alone. Vaccine-induced immune responses remained above baseline up to 1.5 years postvaccination.
    Conclusions: All Ad26.RSV.preF-based regimens were well tolerated. A combination regimen comprising Ad26.RSV.preF, which elicits strong humoral and cellular responses, and RSV preF protein, which increases humoral responses, was selected for further development. Clinical Trials Registration. NCT03502707.
    MeSH term(s) Aged ; Humans ; Antibodies, Neutralizing ; Antibodies, Viral ; Immunity, Humoral ; Immunogenicity, Vaccine ; Respiratory Syncytial Virus Infections/prevention & control ; Respiratory Syncytial Virus Vaccines ; Respiratory Syncytial Virus, Human ; Middle Aged
    Chemical Substances Antibodies, Neutralizing ; Antibodies, Viral ; Respiratory Syncytial Virus Vaccines
    Language English
    Publishing date 2023-07-11
    Publishing country United States
    Document type Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 3019-3
    ISSN 1537-6613 ; 0022-1899
    ISSN (online) 1537-6613
    ISSN 0022-1899
    DOI 10.1093/infdis/jiad220
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