Long-Term Safety and Immunogenicity of AZD1222 (ChAdOx1 nCoV-19): 2-Year Follow-Up from a Phase 3 Study
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| Udgivet i: | Vaccines vol. 12, no. 8 (2024), p. 883 |
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| Hovedforfatter: | |
| Andre forfattere: | , , , , , , , , , , , , , , , |
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| Online adgang: | Citation/Abstract Full Text + Graphics Full Text - PDF |
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| 100 | 1 | |a Shoemaker, Kathryn |u Biometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA; <email>kathryn.shoemaker@astrazeneca.com</email> (K.S.); <email>dongmei.lan@astrazeneca.com</email> (D.L.) | |
| 245 | 1 | |a Long-Term Safety and Immunogenicity of AZD1222 (ChAdOx1 nCoV-19): 2-Year Follow-Up from a Phase 3 Study | |
| 260 | |b MDPI AG |c 2024 | ||
| 513 | |a Journal Article | ||
| 520 | 3 | |a A better understanding of the long-term safety, efficacy, and immunogenicity of COVID-19 vaccines is needed. This phase 3, randomized, placebo-controlled study for AZD1222 (ChAdOx1 nCoV-19) primary-series vaccination enrolled 32,450 participants in the USA, Chile, and Peru between August 2020 and January 2021 (NCT04516746). Endpoints included the 2-year follow-up assessment of safety, efficacy, and immunogenicity. After 2 years, no emergent safety signals were observed for AZD1222, and no cases of thrombotic thrombocytopenia syndrome were reported. The assessment of anti-SARS-CoV-2 nucleocapsid antibody titers confirmed the durability of AZD1222 efficacy for up to 6 months, after which infection rates in the AZD1222 group increased over time. Despite this, all-cause and COVID-19-related mortality remained low through the study end, potentially reflecting the post-Omicron decoupling of SARS-CoV-2 infection rates and severe COVID-19 outcomes. Geometric mean titers were elevated for anti-SARS-CoV-2 neutralizing antibodies at the 1-year study visit and the anti-spike antibodies were elevated at year 2, providing further evidence of increasing SARS-CoV-2 infections over long-term follow-up. Overall, this 2-year follow-up of the AZD1222 phase 3 study confirms that the long-term safety profile remains consistent with previous findings and supports the continued need for COVID-19 booster vaccinations due to waning efficacy and humoral immunity. | |
| 651 | 4 | |a Peru | |
| 651 | 4 | |a United States--US | |
| 651 | 4 | |a Chile | |
| 653 | |a Enrollments | ||
| 653 | |a Infections | ||
| 653 | |a Antibodies | ||
| 653 | |a COVID-19 vaccines | ||
| 653 | |a Severe acute respiratory syndrome coronavirus 2 | ||
| 653 | |a Disease | ||
| 653 | |a Decoupling | ||
| 653 | |a Humoral immunity | ||
| 653 | |a Safety | ||
| 653 | |a Nucleocapsids | ||
| 653 | |a Serology | ||
| 653 | |a Immunity (Disease) | ||
| 653 | |a Immunogenicity | ||
| 653 | |a Pandemics | ||
| 653 | |a Effectiveness | ||
| 653 | |a Illnesses | ||
| 653 | |a COVID-19 | ||
| 653 | |a Thrombocytopenia | ||
| 653 | |a Social | ||
| 700 | 1 | |a Soboleva, Karina |u Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA; <email>karina.soboleva1@astrazeneca.com</email> (K.S.); <email>victor.ezeh@astrazeneca.com</email> (V.E.); | |
| 700 | 1 | |a Branche, Angela |u Division of Infectious Diseases, Department of Medicine, University of Rochester, Rochester, NY 14627, USA; <email>angela_branche@urmc.rochester.edu</email> | |
| 700 | 1 | |a Shankaran, Shivanjali |u Division of Infectious Diseases, Rush University Medical Center, Chicago, IL 60612, USA; <email>shivanjali_shankaran@rush.edu</email> | |
| 700 | 1 | |a Theodore, Deborah A |u Division of Infectious Diseases, Department of Medicine, Vagelos College of Physicians and Surgeons, New York-Presbyterian/Columbia University Irving Medical Center, New York, NY 10032, USA; <email>dat2132@cumc.columbia.edu</email> (D.A.T.); | |
| 700 | 1 | |a Bari, Muhammad |u Formerly Patient Safety, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge CB2 0AA, UK; <email>muhammad.bari@hotmail.com</email> | |
| 700 | 1 | |a Ezeh, Victor |u Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA; <email>karina.soboleva1@astrazeneca.com</email> (K.S.); <email>victor.ezeh@astrazeneca.com</email> (V.E.); | |
| 700 | 1 | |a Green, Justin |u Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Cambridge CB2 0AA, UK | |
| 700 | 1 | |a Kelly, Elizabeth |u Formerly Translational Medicine, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA; <email>beth.j.kelly@gmail.com</email> | |
| 700 | 1 | |a Lan, Dongmei |u Biometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA; <email>kathryn.shoemaker@astrazeneca.com</email> (K.S.); <email>dongmei.lan@astrazeneca.com</email> (D.L.) | |
| 700 | 1 | |a Olsson, Urban |u Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, 431 83 Gothenburg, Sweden; <email>urban.x.olsson@astrazeneca.com</email> | |
| 700 | 1 | |a Senthilkumar Saminathan |u Patient Safety, Chief Medical Office, R&D, AstraZeneca, Bangalore 560045, India; <email>senthilkumar.saminathan@astrazeneca.com</email> (S.S.); <email>nirmalkumar.shankar@astrazeneca.com</email> (N.K.S.) | |
| 700 | 1 | |a Shankar, Nirmal Kumar |u Patient Safety, Chief Medical Office, R&D, AstraZeneca, Bangalore 560045, India; <email>senthilkumar.saminathan@astrazeneca.com</email> (S.S.); <email>nirmalkumar.shankar@astrazeneca.com</email> (N.K.S.) | |
| 700 | 1 | |a Villegas, Berta |u Clinical Operations, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Mississauga, ON L4Y 1M4, Canada; <email>berta.villegas@astrazeneca.com</email> | |
| 700 | 1 | |a Villafana, Tonya |u Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA; <email>karina.soboleva1@astrazeneca.com</email> (K.S.); <email>victor.ezeh@astrazeneca.com</email> (V.E.); | |
| 700 | 1 | |a Falsey, Ann R |u Department of Medicine, Infectious Diseases, University of Rochester School of Medicine and Dentistry, Rochester, New York, NY 14642, USA; <email>ann_falsey@urmc.rochester.edu</email>; Infectious Disease, Rochester Regional Health, Rochester, New York, NY 14617, USA | |
| 700 | 1 | |a Sobieszczyk, Magdalena E |u Division of Infectious Diseases, Department of Medicine, Vagelos College of Physicians and Surgeons, New York-Presbyterian/Columbia University Irving Medical Center, New York, NY 10032, USA; <email>dat2132@cumc.columbia.edu</email> (D.A.T.); | |
| 773 | 0 | |t Vaccines |g vol. 12, no. 8 (2024), p. 883 | |
| 786 | 0 | |d ProQuest |t Biological Science Database | |
| 856 | 4 | 1 | |3 Citation/Abstract |u https://www.proquest.com/docview/3098197633/abstract/embedded/7BTGNMKEMPT1V9Z2?source=fedsrch |
| 856 | 4 | 0 | |3 Full Text + Graphics |u https://www.proquest.com/docview/3098197633/fulltextwithgraphics/embedded/7BTGNMKEMPT1V9Z2?source=fedsrch |
| 856 | 4 | 0 | |3 Full Text - PDF |u https://www.proquest.com/docview/3098197633/fulltextPDF/embedded/7BTGNMKEMPT1V9Z2?source=fedsrch |