Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study.
Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study.
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DOI：
10.1016/s1473-3099(21)00674-5
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发表时间：
2022-03
期刊：
影响因子：
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通讯作者：
Guleria R
中科院分区：
文献类型：
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作者：
Desai D;Khan AR;Soneja M;Mittal A;Naik S;Kodan P;Mandal A;Maher GT;Kumar R;Agarwal A;Gowda NR;H V;Kumar P;Pandey S;Pandey RM;Kumar A;Ray A;Jorwal P;Nischal N;Choudhary A;Brijwal M;Madan K;Lodha R;Sinha S;Dar L;Wig N;Guleria R
BBV152是一种已在印度部署的SARS-CoV-2全病毒灭活疫苗。3期试验的结果显示了BBV152的临床疗效。我们的目的是评价BBV152对经RT-PCR证实的SARS-CoV-2感染的有效性。我们对全印度医学研究所(印度新德里的一家三级保健医院)的员工进行了一项检测阴性的病例对照研究，这些员工有新冠肺炎的症状，并在2021年4月15日至5月15日印度第二波新冠肺炎疫情高峰期进行了SARS-CoV-2的RT-PCR检测。病例(检测阳性)和对照组(检测阴性)根据年龄和性别按1：1配对。比较病例和对照组接种BBV152疫苗的几率，并使用条件Logistic回归分析调整职业暴露水平(接触新冠肺炎)、既往感染SARS-CoV-2和日历时间。主要结果是两剂BBV152(第二剂至少在检测前14天接受)有效地降低了RT-PCR法确认的有症状的SARS-CoV-2感染的几率，表示为(1 - 优势比) × 100%。在2021年4月15日至5月15日期间，3732人接受了RT-PCR测试。其中，2714名有症状的员工有接种疫苗状况的数据，1068对匹配的病例对照可供分析。在试验前至少14天给药两次后，BBV152对症状性新冠肺炎的调整有效率为50%(95%可信区间33-62；p<；0.0001)。在试验前至少28天给药的调整有效率为46%(95%可信区间22-62)，在试验前至少42天给药的调整有效率为57%(21-76)。排除既往感染SARS-CoV-2的参与者后，在检测前至少14天给予两剂疫苗的调整有效率为47%(95%可信区间29-61)。这项研究显示了在病例激增的背景下，两种剂量的BBV152对有症状的新冠肺炎的有效性，据推测，病例主要是潜在的免疫逃避三角洲(B.1.617.2)SARS-CoV-2变种。我们的发现支持继续推出这种疫苗，以帮助控制SARS-CoV-2的传播，同时继续强调坚持非药理学措施。没有。摘要的印地语翻译见补充资料部分。
BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine that has been deployed in India. The results of the phase 3 trial have shown clinical efficacy of BBV152. We aimed to evaluate the effectiveness of BBV152 against symptomatic RT-PCR-confirmed SARS-CoV-2 infection. We conducted a test-negative, case-control study among employees of the All India Institute of Medical Sciences (a tertiary care hospital in New Delhi, India), who had symptoms suggestive of COVID-19 and had an RT-PCR test for SARS-CoV-2 during the peak of the second wave of the COVID-19 pandemic in India between April 15 and May 15, 2021. Cases (test-positives) and controls (test-negatives) were matched (1:1) on the basis of age and gender. The odds of vaccination with BBV152 were compared between cases and controls and adjusted for level of occupational exposure (to COVID-19), previous SARS-CoV-2 infection, and calendar time, using conditional logistic regression. The primary outcome was effectiveness of two doses of BBV152 (with the second dose received at least 14 days before testing) in reducing the odds of symptomatic RT-PCR-confirmed SARS-CoV-2 infection, expressed as (1 – odds ratio) × 100%. Between April 15 and May 15, 2021, 3732 individuals had an RT-PCR test. Of these, 2714 symptomatic employees had data on vaccination status, and 1068 matched case-control pairs were available for analysis. The adjusted effectiveness of BBV152 against symptomatic COVID-19 after two doses administered at least 14 days before testing was 50% (95% CI 33–62; p<0·0001). The adjusted effectiveness of two doses administered at least 28 days before testing was 46% (95% CI 22–62) and administered at least 42 days before testing was 57% (21–76). After excluding participants with previous SARS-CoV-2 infections, the adjusted effectiveness of two doses administered at least 14 days before testing was 47% (95% CI 29–61). This study shows the effectiveness of two doses of BBV152 against symptomatic COVID-19 in the context of a huge surge in cases, presumably dominated by the potentially immune-evasive delta (B.1.617.2) variant of SARS-CoV-2. Our findings support the ongoing roll-out of this vaccine to help control the spread of SARS-CoV-2, while continuing the emphasis on adherence to non-pharmacological measures. None. For the Hindi translation of the abstract see Supplementary Materials section.