Shoemaker Kathryn, Soboleva Karina, Branche Angela, Shankaran Shivanjali, Theodore Deborah A, Bari Muhammad, Ezeh Victor, Green Justin, Kelly Elizabeth, Lan Dongmei, Olsson Urban, Saminathan Senthilkumar, Shankar Nirmal Kumar, Villegas Berta, Villafana Tonya, Falsey Ann R, Sobieszczyk Magdalena E
Biometrics, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.
Clinical Development, Vaccines & Immune Therapies, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA.
Vaccines (Basel). 2024 Aug 3;12(8):883. doi: 10.3390/vaccines12080883.
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.
需要更好地了解新冠疫苗的长期安全性、有效性和免疫原性。这项针对AZD1222（ChAdOx1 nCoV-19）初次系列疫苗接种的3期随机、安慰剂对照研究于2020年8月至2021年1月在美国、智利和秘鲁招募了32450名参与者（NCT04516746）。研究终点包括对安全性、有效性和免疫原性的2年随访评估。2年后，未观察到AZD1222有新出现的安全信号，也未报告血栓性血小板减少综合征病例。抗SARS-CoV-2核衣壳抗体滴度评估证实了AZD1222的有效性可持续长达6个月，之后AZD1222组的感染率随时间增加。尽管如此，直至研究结束，全因死亡率和与新冠相关的死亡率仍然较低，这可能反映了奥密克戎变异株出现后SARS-CoV-2感染率与严重新冠结果之间的脱钩。在1年研究访视时，抗SARS-CoV-2中和抗体的几何平均滴度升高，在第2年抗刺突抗体升高，这为长期随访中SARS-CoV-2感染增加提供了进一步证据。总体而言，AZD1222 3期研究的这项2年随访证实，长期安全性概况与先前的研究结果一致，并支持由于效力和体液免疫减弱，仍需继续接种新冠加强疫苗。
