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  1. Article ; Online: Durable Humoral and Cellular Immune Responses 8 Months after Ad26.COV2.S Vaccination.

    Barouch, Dan H / Stephenson, Kathryn E / Sadoff, Jerald / Yu, Jingyou / Chang, Aiquan / Gebre, Makda / McMahan, Katherine / Liu, Jinyan / Chandrashekar, Abishek / Patel, Shivani / Le Gars, Mathieu / de Groot, Anne M / Heerwegh, Dirk / Struyf, Frank / Douoguih, Macaya / van Hoof, Johan / Schuitemaker, Hanneke

    The New England journal of medicine

    2021  Volume 385, Issue 10, Page(s) 951–953

    MeSH term(s) Ad26COVS1 ; Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; COVID-19 Vaccines/immunology ; Follow-Up Studies ; Humans ; Immunity, Cellular ; Immunity, Humoral ; Immunogenicity, Vaccine ; SARS-CoV-2 ; T-Lymphocytes/physiology ; Vaccination
    Chemical Substances Ad26COVS1 (JT2NS6183B) ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines
    Language English
    Publishing date 2021-07-14
    Publishing country United States
    Document type Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc2108829
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine.

    Sadoff, Jerald / Le Gars, Mathieu / Shukarev, Georgi / Heerwegh, Dirk / Truyers, Carla / de Groot, Anne M / Stoop, Jeroen / Tete, Sarah / Van Damme, Wim / Leroux-Roels, Isabel / Berghmans, Pieter-Jan / Kimmel, Murray / Van Damme, Pierre / de Hoon, Jan / Smith, William / Stephenson, Kathryn E / De Rosa, Stephen C / Cohen, Kristen W / McElrath, M Juliana /
    Cormier, Emmanuel / Scheper, Gert / Barouch, Dan H / Hendriks, Jenny / Struyf, Frank / Douoguih, Macaya / Van Hoof, Johan / Schuitemaker, Hanneke

    The New England journal of medicine

    2021  Volume 384, Issue 19, Page(s) 1824–1835

    Abstract: Background: Efficacious vaccines are urgently needed to contain the ongoing coronavirus disease 2019 (Covid-19) pandemic of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A candidate vaccine, Ad26.COV2.S, is a recombinant, ... ...

    Abstract Background: Efficacious vaccines are urgently needed to contain the ongoing coronavirus disease 2019 (Covid-19) pandemic of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A candidate vaccine, Ad26.COV2.S, is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein.
    Methods: In this multicenter, placebo-controlled, phase 1-2a trial, we randomly assigned healthy adults between the ages of 18 and 55 years (cohort 1) and those 65 years of age or older (cohort 3) to receive the Ad26.COV2.S vaccine at a dose of 5×10
    Results: After the administration of the first vaccine dose in 805 participants in cohorts 1 and 3 and after the second dose in cohort 1, the most frequent solicited adverse events were fatigue, headache, myalgia, and injection-site pain. The most frequent systemic adverse event was fever. Systemic adverse events were less common in cohort 3 than in cohort 1 and in those who received the low vaccine dose than in those who received the high dose. Reactogenicity was lower after the second dose. Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose (geometric mean titer [GMT], 212 to 354), regardless of vaccine dose or age group, and reached 96% by day 57 with a further increase in titers (GMT, 288 to 488) in cohort 1a. Titers remained stable until at least day 71. A second dose provided an increase in the titer by a factor of 2.6 to 2.9 (GMT, 827 to 1266). Spike-binding antibody responses were similar to neutralizing-antibody responses. On day 15, CD4+ T-cell responses were detected in 76 to 83% of the participants in cohort 1 and in 60 to 67% of those in cohort 3, with a clear skewing toward type 1 helper T cells. CD8+ T-cell responses were robust overall but lower in cohort 3.
    Conclusions: The safety and immunogenicity profiles of Ad26.COV2.S support further development of this vaccine candidate. (Funded by Johnson & Johnson and the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services; COV1001 ClinicalTrials.gov number, NCT04436276.).
    MeSH term(s) Ad26COVS1 ; Adolescent ; Adult ; Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; CD4 Lymphocyte Count ; CD4-Positive T-Lymphocytes/metabolism ; CD8-Positive T-Lymphocytes/metabolism ; COVID-19/immunology ; COVID-19/prevention & control ; COVID-19 Vaccines/administration & dosage ; COVID-19 Vaccines/adverse effects ; COVID-19 Vaccines/immunology ; Cohort Studies ; Double-Blind Method ; Humans ; Immunogenicity, Vaccine ; Male ; Middle Aged ; SARS-CoV-2/immunology ; Young Adult
    Chemical Substances Ad26COVS1 (JT2NS6183B) ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines
    Language English
    Publishing date 2021-01-13
    Publishing country United States
    Document type Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMoa2034201
    Database MEDical Literature Analysis and Retrieval System OnLINE

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