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  1. Article ; Online: Clot Twist – D-dimer analysis of healthy adults receiving heterologous or homologous booster COVID-19 vaccine after a single prime dose of Ad26.COV2.S in a phase II randomised open-label trial, BaSiS

    Patel, Faeezah / Le Roux, Jean / Sawry, Shobna / Kieser, Robert / Dhar, Mrinmayee / Gill, Katherine / Lazarus, Erica / Nana, Anusha / Garrett, Nigel / Moore, Penny L / Sigal, Alex / Gray, Glenda / Rees, Helen V / Jacobson, Barry Frank / Fairlie, Lee

    medRxiv

    Abstract: BaSiS (Booster After Sisonke Study) is a prospectively enrolled open-label trial in which healthy adults, with controlled co-morbidities and no prior thrombosis, who received a single Ad26.COV2.S prime vaccination primarily through the Sisonke phase IIIB ...

    Abstract BaSiS (Booster After Sisonke Study) is a prospectively enrolled open-label trial in which healthy adults, with controlled co-morbidities and no prior thrombosis, who received a single Ad26.COV2.S prime vaccination primarily through the Sisonke phase IIIB open label implementation study in South Africa. An exploratory objective evaluated the clotting profiles of participants who were enrolled across 4 sites in South Africa and randomised 1:1:1:1 to receive one of full-dose Ad26.COV2.S, half-dose Ad26.COV2.S, full-dose Comirnaty or half-dose Comirnaty booster. D-dimer testing (INNOVANCE D-Dimer Assay), as a coagulopathy marker, was conducted pre-booster (baseline) and 2 weeks post-booster. The median age among 285 participants was 42.2 years (IQR:35.5-48.7), 235/285 (82.5%) were female, 269/285 (94.4%) were Black African. Of the 40.4% (115/285) people living with HIV (PLHIV), 79.1% (91/115) were well-controlled on antiretroviral therapy. At baseline, 39.3% (112/285) had elevated d-dimers; all asymptomatic. Females and obese participants were significantly more likely to have elevated baseline d-dimers (OR=4.17; 95% CI:1.88 to 9.26 and OR=2.64; 95% CI:1.57 to 4.43, respectively). Of 169 with normal baseline d-dimers, 29 (17.2%) became elevated 2 weeks post-booster: median increase 0.23ug/ml (IQR:0.15-0.42); those receiving full-dose Comirnaty exhibited lower risk of d-dimer elevation post vaccination, compared to other booster vaccination arms (OR:0.26; 95% CI:0.07 to 0.98). PLHIV experienced significantly higher median increases compared to HIV uninfected participants (0.43 vs 0.17, p=0.004). Elevated d-dimers in asymptomatic, low-risk adults were unexpectedly common but were not associated with thromboembolism, supporting the rationale of using d-dimers only if clinically indicated. Trial Registration: South African Clinical Trails Register number DOH-27-012022-7841.
    Keywords covid19
    Language English
    Publishing date 2024-02-21
    Publisher Cold Spring Harbor Laboratory Press
    Document type Article ; Online
    DOI 10.1101/2024.02.19.24303026
    Database COVID19

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  2. Article ; Online: Safety and immunogenicity of booster vaccination and fractional dosing with Ad26.COV2.S or BNT162b2 in Ad26.COV2.S-vaccinated participants.

    Riou, Catherine / Bhiman, Jinal N / Ganga, Yashica / Sawry, Shobna / Ayres, Frances / Baguma, Richard / Balla, Sashkia R / Benede, Ntombi / Bernstein, Mallory / Besethi, Asiphe S / Cele, Sandile / Crowther, Carol / Dhar, Mrinmayee / Geyer, Sohair / Gill, Katherine / Grifoni, Alba / Hermanus, Tandile / Kaldine, Haajira / Keeton, Roanne S /
    Kgagudi, Prudence / Khan, Khadija / Lazarus, Erica / Le Roux, Jean / Lustig, Gila / Madzivhandila, Mashudu / Magugu, Siyabulela F J / Makhado, Zanele / Manamela, Nelia P / Mkhize, Qiniso / Mosala, Paballo / Motlou, Thopisang P / Mutavhatsindi, Hygon / Mzindle, Nonkululeko B / Nana, Anusha / Nesamari, Rofhiwa / Ngomti, Amkele / Nkayi, Anathi A / Nkosi, Thandeka P / Omondi, Millicent A / Panchia, Ravindre / Patel, Faeezah / Sette, Alessandro / Singh, Upasna / van Graan, Strauss / Venter, Elizabeth M / Walters, Avril / Moyo-Gwete, Thandeka / Richardson, Simone I / Garrett, Nigel / Rees, Helen / Bekker, Linda-Gail / Gray, Glenda / Burgers, Wendy A / Sigal, Alex / Moore, Penny L / Fairlie, Lee

    PLOS global public health

    2024  Volume 4, Issue 4, Page(s) e0002703

    Abstract: We report the safety and immunogenicity of fractional and full dose Ad26.COV2.S and BNT162b2 in an open label phase 2 trial of participants previously vaccinated with a single dose of Ad26.COV2.S, with 91.4% showing evidence of previous SARS-CoV-2 ... ...

    Abstract We report the safety and immunogenicity of fractional and full dose Ad26.COV2.S and BNT162b2 in an open label phase 2 trial of participants previously vaccinated with a single dose of Ad26.COV2.S, with 91.4% showing evidence of previous SARS-CoV-2 infection. A total of 286 adults (with or without HIV) were enrolled >4 months after an Ad26.COV2.S prime and randomized 1:1:1:1 to receive either a full or half-dose booster of Ad26.COV2.S or BNT162b2 vaccine. B cell responses (binding, neutralization and antibody dependent cellular cytotoxicity-ADCC), and spike-specific T-cell responses were evaluated at baseline, 2, 12 and 24 weeks post-boost. Antibody and T-cell immunity targeting the Ad26 vector was also evaluated. No vaccine-associated serious adverse events were recorded. The full- and half-dose BNT162b2 boosted anti-SARS-CoV-2 binding antibody levels (3.9- and 4.5-fold, respectively) and neutralizing antibody levels (4.4- and 10-fold). Binding and neutralizing antibodies following half-dose Ad26.COV2.S were not significantly boosted. Full-dose Ad26.COV2.S did not boost binding antibodies but slightly enhanced neutralizing antibodies (2.1-fold). ADCC was marginally increased only after a full-dose BNT162b2. T-cell responses followed a similar pattern to neutralizing antibodies. Six months post-boost, antibody and T-cell responses had waned to baseline levels. While we detected strong anti-vector immunity, there was no correlation between anti-vector immunity in Ad26.COV2.S recipients and spike-specific neutralizing antibody or T-cell responses post-Ad26.COV2.S boosting. Overall, in the context of hybrid immunity, boosting with heterologous full- or half-dose BNT162b2 mRNA vaccine demonstrated superior immunogenicity 2 weeks post-vaccination compared to homologous Ad26.COV2.S, though rapid waning occurred by 12 weeks post-boost. Trial Registration: The study has been registered to the South African National Clinical Trial Registry (SANCTR): DOH-27-012022-7841. The approval letter from SANCTR has been provided in the up-loaded documents.
    Language English
    Publishing date 2024-04-11
    Publishing country United States
    Document type Journal Article
    ISSN 2767-3375
    ISSN (online) 2767-3375
    DOI 10.1371/journal.pgph.0002703
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Safety and immunogenicity of booster vaccination and fractional dosing with Ad26.COV2.S or BNT162b2 in Ad26.COV2.S-vaccinated participants.

    Riou, Catherine / Bhiman, Jinal N / Ganga, Yashica / Sawry, Shobna / Ayres, Frances / Baguma, Richard / Balla, Sashkia R / Benede, Ntombi / Bernstein, Mallory / Besethi, Asiphe S / Cele, Sandile / Crowther, Carol / Dhar, Mrinmayee / Geyer, Sohair / Gill, Katherine / Grifoni, Alba / Hermanus, Tandile / Kaldine, Haajira / Keeton, Roanne S /
    Kgagudi, Prudence / Khan, Khadija / Lazarus, Erica / Roux, Jean Le / Lustig, Gila / Madzivhandila, Mashudu / Magugu, Siyabulela Fj / Makhado, Zanele / Manamela, Nelia P / Mkhize, Qiniso / Mosala, Paballo / Motlou, Thopisang P / Mutavhatsindi, Hygon / Mzindle, Nonkululeko B / Nana, Anusha / Nesamari, Rofhiwa / Ngomti, Amkele / Nkayi, Anathi A / Nkosi, Thandeka P / Omondi, Millicent A / Panchia, Ravindre / Patel, Faeezah / Sette, Alessandro / Singh, Upasna / van Graan, Strauss / Venter, Elizabeth M / Walters, Avril / Moyo-Gwete, Thandeka / Richardson, Simone I / Garrett, Nigel / Rees, Helen / Bekker, Linda-Gail / Gray, Glenda / Burgers, Wendy A / Sigal, Alex / Moore, Penny L / Fairlie, Lee

    medRxiv : the preprint server for health sciences

    2023  

    Abstract: Background: We report the safety and immunogenicity of fractional and full dose Ad26.COV2.S and BNT162b2 in an open label phase 2 trial of participants previously vaccinated with a single dose of Ad26.COV2.S, with 91.4% showing evidence of previous SARS- ...

    Abstract Background: We report the safety and immunogenicity of fractional and full dose Ad26.COV2.S and BNT162b2 in an open label phase 2 trial of participants previously vaccinated with a single dose of Ad26.COV2.S, with 91.4% showing evidence of previous SARS-CoV-2 infection.
    Methods: A total of 286 adults (with or without HIV) were enrolled >4 months after an Ad26.COV2.S prime and randomized 1:1:1:1 to receive either a full or half-dose booster of Ad26.COV2.S or BNT162b2 vaccine. B cell responses (binding, neutralization and antibody dependent cellular cytotoxicity-ADCC), and spike-specific T-cell responses were evaluated at baseline, 2, 12 and 24 weeks post-boost. Antibody and T-cell immunity targeting the Ad26 vector was also evaluated.
    Results: No vaccine-associated serious adverse events were recorded. The full- and half-dose BNT162b2 boosted anti-SARS-CoV-2 binding antibody levels (3.9- and 4.5-fold, respectively) and neutralizing antibody levels (4.4- and 10-fold). Binding and neutralizing antibodies following half-dose Ad26.COV2.S were not significantly boosted. Full-dose Ad26.COV2.S did not boost binding antibodies but slightly enhanced neutralizing antibodies (2.1-fold). ADCC was marginally increased only after a full-dose BNT162b2. T-cell responses followed a similar pattern to neutralizing antibodies. Six months post-boost, antibody and T-cell responses had waned to baseline levels. While we detected strong anti-vector immunity, there was no correlation between anti-vector immunity in Ad26.COV2.S recipients and spike-specific neutralizing antibody or T-cell responses post-Ad26.COV2.S boosting.
    Conclusion: In the context of hybrid immunity, boosting with heterologous full- or half-dose BNT162b2 mRNA vaccine demonstrated superior immunogenicity 2 weeks post-vaccination compared to homologous Ad26.COV2.S, though rapid waning occurred by 12 weeks post-boost.
    Trial registration: South African National Clinical Trial Registry (SANCR): DOH-27-012022-7841.
    Funding: South African Medical Research Council (SAMRC) and South African Department of Health (SA DoH).
    Language English
    Publishing date 2023-11-20
    Publishing country United States
    Document type Preprint
    DOI 10.1101/2023.11.20.23298785
    Database MEDical Literature Analysis and Retrieval System OnLINE

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