Safety, immunogenecity and effectiveness of ChAdOx1 nCoV-19 vaccine during the second wave of pandemic in India: a real-world study.

Q2 Pharmacology, Toxicology and Pharmaceutics

Drug metabolism and personalized therapy Pub Date : 2023-04-26 eCollection Date: 2023-09-01 DOI:10.1515/dmpt-2022-0150

Preeti Chavan, Rajashree Dey, Renita Castelino, Akshay Kamble, Pratik Poladia, Rajani Bagal, Monica Jadhav, Aditi Shirsat, Ashish Chavan, Sachin Dhumal, Sharath Kumar, Manjunath Nookala Krishnamurty, Vivek Bhat, Atanu Bhattacharjee, Vikram Gota

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引用次数: 2

Abstract

Objectives: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

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印度第二波疫情期间ChAdOx1-nCoV-19疫苗的安全性、免疫原性和有效性：一项真实世界的研究。

目的：这项真实世界的研究旨在评估ChAdO×1-nCoV-19疫苗免疫后的不良反应（AEFI）和免疫原性，即中和抗体滴度，并研究年龄、性别、合并症和既往新冠肺炎状况等协变量对这些结果的影响。此外，还根据两剂疫苗的间隔时间对疫苗的有效性进行了研究。方法：在2021年3月至5月期间，共有512名年龄在35岁（18-87岁）的参与者（M/F=274/238）被纳入研究，其中包括医护人员、其他一线工作者和公众。不良事件记录（如有）通过电话收集，在第一次给药后6个月内对参与者进行随访，并根据不良事件通用术语标准（CTCAE）第5版进行分级。在第一次给药后6个月内，使用方便的采样策略连续采集用于测量针对受体结合结构域（RBD）的抗体滴度的血样。截至2021年12月，通过电话收集了突破性新冠肺炎感染的数据。结果：第一剂后局部反应的发生率更高，为33.4 % （171/512）与第二次给药后的12.9 % （66/512）。观察到的最常见副作用是第一次注射后的注射部位疼痛（87.1 %; 149/171）和第二（87.9 %; 56/66）剂量。在全身反应中，发烧是最常见的表现，其次是肌痛和头痛。女性（结论：ChAdOx1-nCov-19疫苗显然对严重急性呼吸系统综合征冠状病毒2型病毒感染安全有效。既往感染新冠肺炎和较年轻的年龄组抗体滴度较高，但没有额外的保护作用。与较短的剂量间隔相比，将第二剂疫苗延迟至至少6周更有效。

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来源期刊

Drug metabolism and personalized therapy Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)

CiteScore

2.30

自引率

0.00%

发文量

期刊介绍： Drug Metabolism and Personalized Therapy (DMPT) is a peer-reviewed journal, and is abstracted/indexed in relevant major Abstracting Services. It provides up-to-date research articles, reviews and opinion papers in the wide field of drug metabolism research, covering established, new and potential drugs, environmentally toxic chemicals, the mechanisms by which drugs may interact with each other and with biological systems, and the pharmacological and toxicological consequences of these interactions and drug metabolism and excretion. Topics: drug metabolizing enzymes, pharmacogenetics and pharmacogenomics, biochemical pharmacology, molecular pathology, clinical pharmacology, pharmacokinetics and drug-drug interactions, immunopharmacology, neuropsychopharmacology.