Maria Danysz, Rute Cardoso De Aguiar, Hema Pindolia, Beth Stuart, Katrina Spensley, Elen Ashmore, Nicole Frumento, Nadège Haouidji-Javaux, Clare Hutchinson, Rachel Iles, Susan Lau, Jordan Rolt, Grace Uwenedi, Hollie Wagg, Eleanor Barnes, Sean H Lim, Alex Richter, Michelle Willicombe
{"title":"在临床易感患者人群中，COVID-19疫苗免疫原性与预防感染和严重疾病之间的关联：观察性研究的系统回顾和荟萃分析","authors":"Maria Danysz, Rute Cardoso De Aguiar, Hema Pindolia, Beth Stuart, Katrina Spensley, Elen Ashmore, Nicole Frumento, Nadège Haouidji-Javaux, Clare Hutchinson, Rachel Iles, Susan Lau, Jordan Rolt, Grace Uwenedi, Hollie Wagg, Eleanor Barnes, Sean H Lim, Alex Richter, Michelle Willicombe","doi":"10.1016/j.cmi.2025.09.020","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The use of measured immune responses in informing risk of breakthrough COVID-19 infection and infection outcomes after vaccination against SARS-CoV-2 in clinically vulnerable patients has not been applied clinically.</p><p><strong>Objectives: </strong>Our aim was to investigate the association between measured vaccine immunogenicity and vaccine effectiveness in clinically vulnerable populations.</p><p><strong>Data sources: </strong>PubMed, MEDLINE, EMBASE, Cochrane Library.</p><p><strong>Study eligibility criteria: </strong>Studies published between 03/2020 and 01/2025, which reported data on COVID-19 vaccine immunogenicity (antibody and T-cell) and subsequent infection outcomes.</p><p><strong>Participants: </strong>Patients defined as clinically vulnerable by QCOVID criteria, who had received at least the primary course of COVID-19 vaccination.</p><p><strong>Assessment of risk of bias: </strong>The Newcastle-Ottawa quality assessment scale was used to assess risk of bias.</p><p><strong>Methods of data synthesis: </strong>A random-effects meta-analysis model was used to pool relative risks of COVID-19 breakthrough infection (BTI), hospitalisation, and death. Unadjusted data was used for the primary analysis due to a lack of adjusted data available in individual studies.</p><p><strong>Results: </strong>We identified 3305 articles, of which 45 observational studies were included in the review. Negative antibody response following COVID-19 vaccination was associated with higher risks of BTI [RR 1.82 (1.45-2.29), p<0.01, I<sup>2</sup>=84.03%], COVID-19 related hospitalisation [RR 5.88 (4.08-8.47), p<0.01, I<sup>2</sup>=25.59%] and death [RR 3.66 (1.87-7.15), p<0.01), I<sup>2</sup>=0%]. Lack of T-cell response was associated with higher risk of BTI [RR 2.08 (1.08-4.04), p=0.03, I<sup>2</sup>=65.99. Using the Newcastle-Ottawa quality assessment scale, 5 (11%) studies were of good quality, 2 (7%) of fair quality, and 37 (82%) of poor quality.</p><p><strong>Conclusions: </strong>Within the methodological limitations, this study has shown that lack of anti-spike antibody responses was associated with BTI and severe infection outcomes in clinically vulnerable populations. Further research is required to investigate the current utility of testing to inform the ongoing management of clinically vulnerable persons, such as vaccine booster schedules.</p>","PeriodicalId":10444,"journal":{"name":"Clinical Microbiology and Infection","volume":" ","pages":""},"PeriodicalIF":8.5000,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Association between COVID-19 vaccine immunogenicity and protection against infection and severe disease in clinically vulnerable patient populations: a systematic review and meta-analysis of observational studies.\",\"authors\":\"Maria Danysz, Rute Cardoso De Aguiar, Hema Pindolia, Beth Stuart, Katrina Spensley, Elen Ashmore, Nicole Frumento, Nadège Haouidji-Javaux, Clare Hutchinson, Rachel Iles, Susan Lau, Jordan Rolt, Grace Uwenedi, Hollie Wagg, Eleanor Barnes, Sean H Lim, Alex Richter, Michelle Willicombe\",\"doi\":\"10.1016/j.cmi.2025.09.020\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The use of measured immune responses in informing risk of breakthrough COVID-19 infection and infection outcomes after vaccination against SARS-CoV-2 in clinically vulnerable patients has not been applied clinically.</p><p><strong>Objectives: </strong>Our aim was to investigate the association between measured vaccine immunogenicity and vaccine effectiveness in clinically vulnerable populations.</p><p><strong>Data sources: </strong>PubMed, MEDLINE, EMBASE, Cochrane Library.</p><p><strong>Study eligibility criteria: </strong>Studies published between 03/2020 and 01/2025, which reported data on COVID-19 vaccine immunogenicity (antibody and T-cell) and subsequent infection outcomes.</p><p><strong>Participants: </strong>Patients defined as clinically vulnerable by QCOVID criteria, who had received at least the primary course of COVID-19 vaccination.</p><p><strong>Assessment of risk of bias: </strong>The Newcastle-Ottawa quality assessment scale was used to assess risk of bias.</p><p><strong>Methods of data synthesis: </strong>A random-effects meta-analysis model was used to pool relative risks of COVID-19 breakthrough infection (BTI), hospitalisation, and death. Unadjusted data was used for the primary analysis due to a lack of adjusted data available in individual studies.</p><p><strong>Results: </strong>We identified 3305 articles, of which 45 observational studies were included in the review. Negative antibody response following COVID-19 vaccination was associated with higher risks of BTI [RR 1.82 (1.45-2.29), p<0.01, I<sup>2</sup>=84.03%], COVID-19 related hospitalisation [RR 5.88 (4.08-8.47), p<0.01, I<sup>2</sup>=25.59%] and death [RR 3.66 (1.87-7.15), p<0.01), I<sup>2</sup>=0%]. Lack of T-cell response was associated with higher risk of BTI [RR 2.08 (1.08-4.04), p=0.03, I<sup>2</sup>=65.99. Using the Newcastle-Ottawa quality assessment scale, 5 (11%) studies were of good quality, 2 (7%) of fair quality, and 37 (82%) of poor quality.</p><p><strong>Conclusions: </strong>Within the methodological limitations, this study has shown that lack of anti-spike antibody responses was associated with BTI and severe infection outcomes in clinically vulnerable populations. Further research is required to investigate the current utility of testing to inform the ongoing management of clinically vulnerable persons, such as vaccine booster schedules.</p>\",\"PeriodicalId\":10444,\"journal\":{\"name\":\"Clinical Microbiology and Infection\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":8.5000,\"publicationDate\":\"2025-09-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Microbiology and Infection\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.cmi.2025.09.020\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Microbiology and Infection","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cmi.2025.09.020","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Association between COVID-19 vaccine immunogenicity and protection against infection and severe disease in clinically vulnerable patient populations: a systematic review and meta-analysis of observational studies.
Background: The use of measured immune responses in informing risk of breakthrough COVID-19 infection and infection outcomes after vaccination against SARS-CoV-2 in clinically vulnerable patients has not been applied clinically.
Objectives: Our aim was to investigate the association between measured vaccine immunogenicity and vaccine effectiveness in clinically vulnerable populations.
Data sources: PubMed, MEDLINE, EMBASE, Cochrane Library.
Study eligibility criteria: Studies published between 03/2020 and 01/2025, which reported data on COVID-19 vaccine immunogenicity (antibody and T-cell) and subsequent infection outcomes.
Participants: Patients defined as clinically vulnerable by QCOVID criteria, who had received at least the primary course of COVID-19 vaccination.
Assessment of risk of bias: The Newcastle-Ottawa quality assessment scale was used to assess risk of bias.
Methods of data synthesis: A random-effects meta-analysis model was used to pool relative risks of COVID-19 breakthrough infection (BTI), hospitalisation, and death. Unadjusted data was used for the primary analysis due to a lack of adjusted data available in individual studies.
Results: We identified 3305 articles, of which 45 observational studies were included in the review. Negative antibody response following COVID-19 vaccination was associated with higher risks of BTI [RR 1.82 (1.45-2.29), p<0.01, I2=84.03%], COVID-19 related hospitalisation [RR 5.88 (4.08-8.47), p<0.01, I2=25.59%] and death [RR 3.66 (1.87-7.15), p<0.01), I2=0%]. Lack of T-cell response was associated with higher risk of BTI [RR 2.08 (1.08-4.04), p=0.03, I2=65.99. Using the Newcastle-Ottawa quality assessment scale, 5 (11%) studies were of good quality, 2 (7%) of fair quality, and 37 (82%) of poor quality.
Conclusions: Within the methodological limitations, this study has shown that lack of anti-spike antibody responses was associated with BTI and severe infection outcomes in clinically vulnerable populations. Further research is required to investigate the current utility of testing to inform the ongoing management of clinically vulnerable persons, such as vaccine booster schedules.
期刊介绍：
Clinical Microbiology and Infection (CMI) is a monthly journal published by the European Society of Clinical Microbiology and Infectious Diseases. It focuses on peer-reviewed papers covering basic and applied research in microbiology, infectious diseases, virology, parasitology, immunology, and epidemiology as they relate to therapy and diagnostics.
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