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Long-Term Safety and Immunogenicity of AZD1222 (ChAdOx1 nCoV-19): 2-Year Follow-Up from a Phase 3 Study

Guardado en:
Publicado en:Vaccines vol. 12, no. 8 (2024), p. 883
Autor principal: Shoemaker, Kathryn
Otros Autores: Soboleva, Karina, Branche, Angela, Shankaran, Shivanjali, Theodore, Deborah A, Bari, Muhammad, Ezeh, Victor, Green, Justin, Kelly, Elizabeth, Lan, Dongmei, Olsson, Urban, Senthilkumar Saminathan, Shankar, Nirmal Kumar, Villegas, Berta, Villafana, Tonya, Falsey, Ann R, Sobieszczyk, Magdalena E
Publicado:
MDPI AG
Materias:
Peru
United States > US
Chile
Enrollments
Infections
Antibodies
COVID-19 vaccines
Severe acute respiratory syndrome coronavirus 2
Disease
Decoupling
Humoral immunity
Safety
Nucleocapsids
Serology
Immunity (Disease)
Immunogenicity
Pandemics
Effectiveness
Illnesses
COVID-19
Thrombocytopenia
Social
Acceso en línea:Citation/Abstract
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Resumen: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.
ISSN:2076-393X
DOI:10.3390/vaccines12080883
Fuente:Biological Science Database