Walter D. Park BS , Sumi S. Nair MBBS, MD , Hani M. Wadei MD , Yun Liang MD , Byron H. Smith PhD , Ahmed Abdelrheem MB, BCh , Carrie A. Schinstock MD , Crescent R. Isham MA , Attila Kumanovics MD , Nina Ahmad MD , Richard B. Simonson BS , Martin F. Ryser MD , Gabriela Tapia-Cealle , Andrew D. Badley MD , Mark D. Stegall MD
{"title":"肾移植受者对疫苗接种和强化的反应。","authors":"Walter D. Park BS , Sumi S. Nair MBBS, MD , Hani M. Wadei MD , Yun Liang MD , Byron H. Smith PhD , Ahmed Abdelrheem MB, BCh , Carrie A. Schinstock MD , Crescent R. Isham MA , Attila Kumanovics MD , Nina Ahmad MD , Richard B. Simonson BS , Martin F. Ryser MD , Gabriela Tapia-Cealle , Andrew D. Badley MD , Mark D. Stegall MD","doi":"10.1016/j.mayocp.2025.03.017","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>To assess heterologous booster (HB) with Janssen Ad26.COV2.S in kidney transplant recipients (KTRs) with low antibody levels after multiple COVID-19 mRNA vaccinations.</div></div><div><h3>Patients and Methods</h3><div>This multicenter study examined anti–spike protein antibody levels in KTRs with two or more doses of mRNA vaccinations. Enrollment was from April 11, 2022, to September 19, 2023. Kidney transplant recipients with low levels (LL, 0.4-250 IU/mL) were offered HB with Janssen Ad26.COV2.S vaccine. Those with undetectable levels (UL, <0.4 IU/mL) were randomized to HB with or without immunosuppression adjustment. The primary endpoint was anti–spike protein antibody levels greater than 250 IU/mL (high level [HL]) at 28 days after HB. Subset analysis included lymphocyte, immunoglobulin, and COVID-19–specific T- and B-cell levels.</div></div><div><h3>Results</h3><div>Of the 419 unique KTRs assessed, 80.0% (n=335) were HL, 12.9% (n=54) were LL, and 7.2% (n=30) were UL. All KTRs vaccinated pretransplantation had detectable levels. Twenty-eight days after HB, 62.9% (n=22 of 35) of patients with LL achieved HL. Although 9 of 20 (45%) patients with UL achieved LL, none achieved HL by 28 days despite mycophenolate mofetil cessation before HB. Undetectable level was associated with fewer T and B cells in many subsets and fewer COVID-19–specific memory B cells.</div></div><div><h3>Conclusion</h3><div>Most KTRs had HL anti–spike protein antibodies after two or more mRNA vaccinations due to vaccinations with or without prior infection. Many LL patients responded to HB. No UL reached HL; likely due to severely impaired immune system. In this KTR population, a potential durable antibody response was identified if vaccinated before transplantation. Ultimately, monitoring antibody levels after vaccination might identify patients who could benefit from alternative prophylaxis strategies. ClinicalTrials.gov <span><span>NCT05220397</span><svg><path></path></svg></span></div></div>","PeriodicalId":18334,"journal":{"name":"Mayo Clinic proceedings","volume":"100 9","pages":"Pages 1506-1518"},"PeriodicalIF":6.7000,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Responses of Kidney Transplant Recipients to Vaccination and Boosting\",\"authors\":\"Walter D. Park BS , Sumi S. Nair MBBS, MD , Hani M. Wadei MD , Yun Liang MD , Byron H. Smith PhD , Ahmed Abdelrheem MB, BCh , Carrie A. Schinstock MD , Crescent R. Isham MA , Attila Kumanovics MD , Nina Ahmad MD , Richard B. Simonson BS , Martin F. Ryser MD , Gabriela Tapia-Cealle , Andrew D. Badley MD , Mark D. Stegall MD\",\"doi\":\"10.1016/j.mayocp.2025.03.017\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>To assess heterologous booster (HB) with Janssen Ad26.COV2.S in kidney transplant recipients (KTRs) with low antibody levels after multiple COVID-19 mRNA vaccinations.</div></div><div><h3>Patients and Methods</h3><div>This multicenter study examined anti–spike protein antibody levels in KTRs with two or more doses of mRNA vaccinations. Enrollment was from April 11, 2022, to September 19, 2023. Kidney transplant recipients with low levels (LL, 0.4-250 IU/mL) were offered HB with Janssen Ad26.COV2.S vaccine. Those with undetectable levels (UL, <0.4 IU/mL) were randomized to HB with or without immunosuppression adjustment. The primary endpoint was anti–spike protein antibody levels greater than 250 IU/mL (high level [HL]) at 28 days after HB. Subset analysis included lymphocyte, immunoglobulin, and COVID-19–specific T- and B-cell levels.</div></div><div><h3>Results</h3><div>Of the 419 unique KTRs assessed, 80.0% (n=335) were HL, 12.9% (n=54) were LL, and 7.2% (n=30) were UL. All KTRs vaccinated pretransplantation had detectable levels. Twenty-eight days after HB, 62.9% (n=22 of 35) of patients with LL achieved HL. Although 9 of 20 (45%) patients with UL achieved LL, none achieved HL by 28 days despite mycophenolate mofetil cessation before HB. Undetectable level was associated with fewer T and B cells in many subsets and fewer COVID-19–specific memory B cells.</div></div><div><h3>Conclusion</h3><div>Most KTRs had HL anti–spike protein antibodies after two or more mRNA vaccinations due to vaccinations with or without prior infection. Many LL patients responded to HB. No UL reached HL; likely due to severely impaired immune system. In this KTR population, a potential durable antibody response was identified if vaccinated before transplantation. Ultimately, monitoring antibody levels after vaccination might identify patients who could benefit from alternative prophylaxis strategies. ClinicalTrials.gov <span><span>NCT05220397</span><svg><path></path></svg></span></div></div>\",\"PeriodicalId\":18334,\"journal\":{\"name\":\"Mayo Clinic proceedings\",\"volume\":\"100 9\",\"pages\":\"Pages 1506-1518\"},\"PeriodicalIF\":6.7000,\"publicationDate\":\"2025-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Mayo Clinic proceedings\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0025619625001685\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Mayo Clinic proceedings","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0025619625001685","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Responses of Kidney Transplant Recipients to Vaccination and Boosting
Objective
To assess heterologous booster (HB) with Janssen Ad26.COV2.S in kidney transplant recipients (KTRs) with low antibody levels after multiple COVID-19 mRNA vaccinations.
Patients and Methods
This multicenter study examined anti–spike protein antibody levels in KTRs with two or more doses of mRNA vaccinations. Enrollment was from April 11, 2022, to September 19, 2023. Kidney transplant recipients with low levels (LL, 0.4-250 IU/mL) were offered HB with Janssen Ad26.COV2.S vaccine. Those with undetectable levels (UL, <0.4 IU/mL) were randomized to HB with or without immunosuppression adjustment. The primary endpoint was anti–spike protein antibody levels greater than 250 IU/mL (high level [HL]) at 28 days after HB. Subset analysis included lymphocyte, immunoglobulin, and COVID-19–specific T- and B-cell levels.
Results
Of the 419 unique KTRs assessed, 80.0% (n=335) were HL, 12.9% (n=54) were LL, and 7.2% (n=30) were UL. All KTRs vaccinated pretransplantation had detectable levels. Twenty-eight days after HB, 62.9% (n=22 of 35) of patients with LL achieved HL. Although 9 of 20 (45%) patients with UL achieved LL, none achieved HL by 28 days despite mycophenolate mofetil cessation before HB. Undetectable level was associated with fewer T and B cells in many subsets and fewer COVID-19–specific memory B cells.
Conclusion
Most KTRs had HL anti–spike protein antibodies after two or more mRNA vaccinations due to vaccinations with or without prior infection. Many LL patients responded to HB. No UL reached HL; likely due to severely impaired immune system. In this KTR population, a potential durable antibody response was identified if vaccinated before transplantation. Ultimately, monitoring antibody levels after vaccination might identify patients who could benefit from alternative prophylaxis strategies. ClinicalTrials.gov NCT05220397
期刊介绍:
Mayo Clinic Proceedings is a premier peer-reviewed clinical journal in general medicine. Sponsored by Mayo Clinic, it is one of the most widely read and highly cited scientific publications for physicians. Since 1926, Mayo Clinic Proceedings has continuously published articles that focus on clinical medicine and support the professional and educational needs of its readers. The journal welcomes submissions from authors worldwide and includes Nobel-prize-winning research in its content. With an Impact Factor of 8.9, Mayo Clinic Proceedings is ranked #20 out of 167 journals in the Medicine, General and Internal category, placing it in the top 12% of these journals. It invites manuscripts on clinical and laboratory medicine, health care policy and economics, medical education and ethics, and related topics.