Chavan Preeti, Dey Rajashree, Castelino Renita, Kamble Akshay, Poladia Pratik, Bagal Rajani, Jadhav Monica, Shirsat Aditi, Chavan Ashish, Dhumal Sachin, Kumar Sharath, Krishnamurty Manjunath Nookala, Bhat Vivek, Bhattacharjee Atanu, Gota Vikram
Composite Lab, ACTREC, Tata Memorial Centre, Navi Mumbai, India.
Homi Bhabha National Institute, Training School Complex, Anushakti Nagar, Mumbai, India.
Drug Metab Pers Ther. 2023 Apr 26;38(3):227-236. doi: 10.1515/dmpt-2022-0150. eCollection 2023 Sep 1.
This real-world study was conducted to assess the adverse effects following immunization (AEFI) and immunogenicity of ChAdO×1 nCoV-19 vaccine in terms of neutralising antibody titers and to study the effects of covariates such as age, sex, comorbidities and prior COVID status on these outcomes. Also, the effectiveness of the vaccine based on interval between the two doses was also investigated.
A total of 512 participants (M/F=274/238) aged 35(18-87) years comprising a mixed population of healthcare workers, other frontline workers and general public were enrolled between March and May 2021. Records for adverse events if any were collected telephonically by following up with participants up to 6 months post first dose and graded as per Common Terminology Criteria for Adverse Events (CTCAE) version 5. Blood samples for measuring antibody titers against the receptor binding domain (RBD) were collected serially using a convenient sampling strategy up to 6 months after the first dose. Data on breakthrough COVID infection was collected telephonically till December 2021.
Incidence of local reactions was higher after first dose at 33.4 % (171/512) compared to those after second dose at 12.9 % (66/512). Commonest side effect observed was injection site pain after the first (87.1 %; 149/171) and second (87.9 %; 56/66) dose respectively. Among systemic reactions, fever was the most common manifestation followed by myalgia and headache. Female sex (p<0⸱001) and age less than 60 years (p<0⸱001) had significantly higher predilection for systemic toxicities. Age ≤60 years (p=0.024) and prior-COVID (p<0.001) were found to be significantly associated with higher antibody titers, however, no association was found between these variables and breakthrough COVID infection. Longer spacing between the doses (≥6 weeks) was found to offer better protection against breakthrough infection compared to a spacing of 4 weeks. All breakthroughs were mild-moderate in severity, not requiring hospitalization.
The ChAdOx1 nCov-19 vaccine is apparently safe and effective against SARS-CoV-2 virus infection. Prior COVID infection and younger age group achieve higher antibody titers, but no additional protection. Delaying the second dose up to at least 6 weeks is more effective compared to shorter spacing between doses.
本项真实世界研究旨在评估ChAdO×1 nCoV-19疫苗接种后的不良反应（AEFI）以及基于中和抗体滴度的免疫原性，并研究年龄、性别、合并症和既往新冠感染状况等协变量对这些结果的影响。此外，还研究了基于两剂疫苗接种间隔的疫苗有效性。
2021年3月至5月，共招募了512名年龄在35岁（18 - 87岁）之间的参与者（男/女 = 274/238），包括医护人员、其他一线工作者和普通公众的混合人群。通过电话随访首次接种后长达6个月的参与者，收集任何不良事件的记录，并根据《不良事件通用术语标准》（CTCAE）第5版进行分级。使用便捷抽样策略在首次接种后长达6个月内连续采集用于测量针对受体结合域（RBD）抗体滴度的血样。通过电话收集直至2021年12月的突破性新冠感染数据。
首次接种后局部反应的发生率为33.4%（171/512），高于第二次接种后的12.9%（66/512）。观察到的最常见副作用分别是首次（87.1%；149/171）和第二次（87.9%；56/66）接种后的注射部位疼痛。在全身反应中，发热是最常见的表现，其次是肌痛和头痛。女性（p<0.001）和年龄小于60岁（p<0.001）对全身毒性的易感性显著更高。年龄≤60岁（p = 0.024）和既往感染新冠（p<0.001）与更高的抗体滴度显著相关，然而，未发现这些变量与突破性新冠感染之间存在关联。与4周的间隔相比，发现更长的接种间隔（≥6周）能更好地预防突破性感染。所有突破性感染的严重程度均为轻至中度，无需住院治疗。
ChAdOx1 nCov-19疫苗对SARS-CoV-2病毒感染显然是安全有效的。既往新冠感染和较年轻年龄组的抗体滴度更高，但无额外保护作用。与较短的接种间隔相比，将第二剂推迟至少6周更有效。
