sars-cov-2灭活疫苗(vero细胞)bbibp-corv(国药)的免疫原性和安全性一项来自巴基斯坦的观察性研究

PAFMJ Pub Date : 2021-12-30 DOI:10.51253/pafmj.v6i6.7034
Muhammad Farooq, Muhammad Fayyaz Malik, Ashfaq Hussain, M. Latif, Muhammad Usman Rathore, Rehan Ahmad Khan Lodhi
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摘要

目的:确定中国医药集团(中国医药集团)SARS-CoV-2灭活疫苗(Vero Cell)的免疫原性和短期安全性。研究设计:横断面研究。学习地点和时间:巴基斯坦锡亚尔科特联合军事医院,2021年2月至4月。方法:共有227名年龄在18至59岁之间的卫生保健工作者(HCWs)被纳入研究。所有个体间隔21天接种两剂灭活SARS-CoV-2疫苗(Vero Cell), BBIBP-CorV,并在每次给药后7天监测疫苗相关不良反应。用Elecsys Anti- SARS-CoV-2 S(罗氏诊断公司)在首次接种前、第一次接种后21天和第二次接种后14天三个样本中检测受试者的中和抗体(nab)。结果:本组患者平均年龄36.70±18.08岁,以31 ~ 45岁年龄组居多。疲劳和嗜睡是研究对象在接种第一剂和第二剂疫苗后最常见的不良反应,其次是不适和头痛。只有42人(39%)在第一次接种疫苗后21天的样本中出现阳性中和抗体滴度,而除1人(99%)外,所有人在第二次接种疫苗后2周的样本中出现阳性中和抗体滴度。结论:SARS-CoV-2灭活疫苗(Vero Cell) BBIBP-CorV安全、耐受性好,不良反应极少。免疫原性良好,第二次接种后两周血清转化率为99%。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
IMMUNOGENICITY AND SAFETY OF INACTIVATED SARS-COV-2 VACCINE (VERO CELL), BBIBP-CORV (SINOPHARM); AN OBSERVATIONAL STUDY FROM PAKISTAN
Objective: To ascertain the immunogenicity and short-term safety of inactivated SARS-CoV-2 Vaccine (Vero Cell), BBIBPCorV (Sinopharm) in our setup. Study Design: Cross-sectional study. Place and Duration of Study: Combined Military Hospital Sialkot Pakistan, from Feb to Apr 2021. Methodology: A total of 227 health care workers (HCWs) between 18 to 59 years of age were included in the study. Two doses of Inactivated SARS-CoV-2 Vaccine (Vero Cell), BBIBP-CorV were administered to all individuals 21 days apart and they were monitored for any vaccine-related adverse reactions for 7 days after each dose. Neutralizing antibodies (NAbs) in study subjects were detected in three samples i.e. before 1st dose of vaccine, 21 days after 1st dose and 14 days after 2nd dose by Elecsys Anti- SARS-CoV-2 S (Roche Diagnostics). Results: Mean age of individuals in the study was 36.70 ± 18.08 years and most individuals were in the 31-45 years age group. Fatigue and drowsiness were the most common adverse effects experienced by study subjects after 1st and 2nd dose of the vaccine followed by malaise and headache. Only 42 (39%) individuals developed positive neutralizing antibody titers in a sample taken 21 days after 1st dose while all individuals except one (99%) developed positive neutralizing antibody titers in a sample taken 2 weeks after 2nd vaccine dose. Conclusion: Inactivated SARS-CoV-2 Vaccine (Vero Cell), BBIBP-CorV is safe and well-tolerated with very few adverse reactions. Immunogenicity was well achieved as the seroconversion rate was 99% two weeks after 2nd dose of the vaccine.
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