Gupta Madhu, Sharma Indrakshi, Singh Mini P, Ghosh Arnab, Mohindra Ritin, Suri Vikas, Bhalla Ashish, Devnani Mahesh, Verma Sanjay
Department of Community Medicine and School of Public Health, PGIMER, Chandigarh, India.
Department of Virology, PGIMER, Chandigarh, India.
J Family Med Prim Care. 2025 Feb;14(2):655-661. doi: 10.4103/jfmpc.jfmpc_935_24. Epub 2025 Feb 21.
A prospective longitudinal study was planned to assess immunogenicity, safety, and breakthrough infection rates among health care workers (HCWs) after COVISHIELD™ vaccination in a teaching institute in North India.
A total of 518 HCWs were enrolled at baseline for receiving first dose of COVISHIELD™, 429 continued participation for second dose, 415 followed up at 28 days after second dose, 405 at 6 months, and 403 at 1 year from February 2021 to November 2022. At each visit prior, 2 ml of blood sample was collected and plasma separated. Anti-SARS-Cov-2 IgG antibodies against spike protein were detected by Chemiluminescent Immuno-Assay on the VITROS 3600 platform (Ortho-clinical Diagnostics, NJ, USA). Data were analysed for 403 HCWs (completed all follow-ups), using Statistical Package for Social Sciences version 21.0.
The mean age of participants was 35.3 years (SD ± 11.11), and males were 50.2%. At baseline (N = 518), proportion of reactive HCWs was 25% (95% CI, 21-29%), which increased significantly to 92% (95% CI, 89-95%) after receiving first dose (N = 403), 95% (95% CI, 92-96%) after second dose (N = 403), and declined to 85% (95% CI, 83-93%) at six months (N = 403). At 1 year, reactivity increased to 89.3% (95% CI, 86-90%; value < 0.0001). Fever was reported by 31.2% of HCWs, followed by pain at injection site (27.6%), malaise (16.4%), headache (3.7%), and dizziness (3.7%).
Immunogenicity post-COVISHIELD™ vaccination increased after first and second doses but declined after 6 months and inclined after 1 year of the first dose. The safety profile was within acceptable limits.
计划在印度北部的一所教学机构开展一项前瞻性纵向研究，以评估医护人员接种COVISHIELD™疫苗后的免疫原性、安全性和突破性感染率。
2021年2月至2022年11月期间，共有518名医护人员在基线时登记接种第一剂COVISHIELD™，429人继续参与接种第二剂，415人在第二剂接种后28天进行随访，405人在6个月时随访，403人在1年时随访。每次随访前，采集2毫升血样并分离血浆。在VITROS 3600平台（美国新泽西州奥多临床诊断公司）上通过化学发光免疫分析法检测针对刺突蛋白的抗SARS-CoV-2 IgG抗体。使用社会科学统计软件包第21.0版对403名医护人员（完成所有随访）的数据进行分析。
参与者的平均年龄为35.3岁（标准差±11.11），男性占50.2%。在基线时（N = 518），反应性医护人员的比例为25%（95%置信区间，21-29%），接种第一剂后（N = 403）显著增加至92%（95%置信区间，89-95%），接种第二剂后（N = 403）为95%（95%置信区间，92-96%），6个月时（N = 403）降至85%（95%置信区间，83-93%）。在1年时，反应性增加到89.3%（95%置信区间，86-90%；P值<0.0001）。31.2%的医护人员报告有发热，其次是注射部位疼痛（27.6%）、不适（16.4%）、头痛（3.7%）和头晕（3.7%）。
COVISHIELD™疫苗接种后的免疫原性在第一剂和第二剂后增加，但在第一剂接种6个月后下降，1年后又上升。安全性在可接受范围内。
