Prasad S Kulkarni, Chandrasekaran Padmapriyadarsini, Johan Vekemans, Ashish Bavdekar, Madhu Gupta, Praveen Kulkarni, B S Garg, Nithya J Gogtay, Muralidhar Tambe, Sanjay Lalwani, Kiranjit Singh, Renuka Munshi, Sushant Meshram, T S Selvavinayagam, Krishna Pandey, Devi Madhavi Bhimarasetty, S R Ramakrishnan, Chetanraj Bhamare, Abhijeet Dharmadhikari, Chandrashekhar Budhawant, Cyrille J Bonhomme, Madhuri Thakar, Swarali N Kurle, Elizabeth J Kelly, Manish Gautam, Nivedita Gupta, Samiran Panda, Balram Bhargava, Cyrus S Poonawalla, Umesh Shaligram, Dhananjay Kapse, Bhagwat Gunale
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The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort <i>n</i> = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort <i>n</i> = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41-0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44-1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. 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引用次数: 0
摘要
AZD1222(ChAdOx1 nCoV-19)是一种复制缺陷型腺病毒载体冠状病毒病-19(COVID-19)疫苗,由印度血清研究所有限公司(Serum Institute of India Pvt Ltd)根据牛津大学/阿斯利康公司(Oxford University/AstraZeneca)的技术转让生产,名为 SII-ChAdOx1 nCoV-19。SII-ChAdOx1 nCoV-19 与 AZD1222 的非劣效性先前已在一项观察盲、2/3 期免疫桥接研究中得到证实(试验登记:CTRI/2020/08/027170)。在首次接种后 6 个月(第 180 天)的免疫原性和安全性数据分析中,1,601 名参与者按 3:1 的比例随机接种了 SII-ChAdOx1 nCoV-19 或 AZD1222(免疫原性/反应原性队列 n = 401),并按 3:1 的比例随机接种了 SII-ChAdOx1 nCoV-19 或安慰剂(安全性队列 n = 1,200)。免疫原性通过抗严重急性呼吸系统综合征冠状病毒 2 尖峰(抗-S)结合免疫球蛋白 G 和中和抗体(nAb)滴度来测定。两组疫苗接种者的抗-S滴度均出现下降,但SII-ChAdOx1 nCoV-19接种者的下降幅度更大(几何平均滴度[GMT]比值[SII-ChAdOx1 nCoV-19与AZD1222的95%置信区间(CI)]:0.60 [0.41-0.60]] :0.60 [0.41-0.87]).不同疫苗组之间的 nAb 滴度下降幅度相似(GMT 比值[95% CI]:0.88 [0.44-1.73])。接种疫苗后未出现严重的 COVID-19 病例,而安慰剂组出现了一例。180天内未报告任何与因果关系相关的严重不良事件。没有特别值得关注的血栓栓塞或自身免疫不良事件报告。总之,这些数据表明,SII-ChAdOx1 nCoV-19 在接种后 6 个月内保持了较高的免疫原性。SII-ChAdOx1 nCoV-19 安全且耐受性良好。
Seropersistence of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine): 6-month follow-up of a randomized, controlled, observer-blind, phase 2/3 immuno-bridging study in Indian adults.
AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200). Immunogenicity was measured by anti-severe acute respiratory syndrome coronavirus 2 spike (anti-S) binding immunoglobulin G and neutralizing antibody (nAb) titers. A decline in anti-S titers was observed in both vaccine groups, albeit with a greater decline in SII-ChAdOx1 nCoV-19 vaccinees (geometric mean titer [GMT] ratio [95% confidence interval (CI) of SII-ChAdOx1 nCoV-19 to AZD1222]: 0.60 [0.41-0.87]). Consistent similar decreases in nAb titers were observed between vaccine groups (GMT ratio [95% CI]: 0.88 [0.44-1.73]). No cases of severe COVID-19 were reported following vaccination, while one case was observed in the placebo group. No causally related serious adverse events were reported through 180 days. No thromboembolic or autoimmune adverse events of special interest were reported. Collectively, these data illustrate that SII-ChAdOx1 nCoV-19 maintained a high level of immunogenicity 6 months post-vaccination. SII-ChAdOx1 nCoV-19 was safe and well tolerated.
期刊介绍:
(formerly Human Vaccines; issn 1554-8619)
Vaccine research and development is extending its reach beyond the prevention of bacterial or viral diseases. There are experimental vaccines for immunotherapeutic purposes and for applications outside of infectious diseases, in diverse fields such as cancer, autoimmunity, allergy, Alzheimer’s and addiction. Many of these vaccines and immunotherapeutics should become available in the next two decades, with consequent benefit for human health. Continued advancement in this field will benefit from a forum that can (A) help to promote interest by keeping investigators updated, and (B) enable an exchange of ideas regarding the latest progress in the many topics pertaining to vaccines and immunotherapeutics.
Human Vaccines & Immunotherapeutics provides such a forum. It is published monthly in a format that is accessible to a wide international audience in the academic, industrial and public sectors.