Radka Lordick Obermannova, Iveta Selingerova, Regina Demlova, Dominika Okruhlicova, Jiri Nevrlka, Katerina Cerna-Pilatova, Kristina Greplova, Zdenka Cermakova, Dalibor Valik, Igor Kiss, Marketa Palacova, Alexandr Poprach, Hana Lejdarova, Sarka Selvekerova, Martina Vaneckova, Lenka Zdrazilova-Dubska
{"title":"初始BNT162b2 COVID-19疫苗接种后积极治疗的实体癌患者的sars - cov -2特异性体液和细胞免疫反应模式：来自IV期CoVigi试验的结果","authors":"Radka Lordick Obermannova, Iveta Selingerova, Regina Demlova, Dominika Okruhlicova, Jiri Nevrlka, Katerina Cerna-Pilatova, Kristina Greplova, Zdenka Cermakova, Dalibor Valik, Igor Kiss, Marketa Palacova, Alexandr Poprach, Hana Lejdarova, Sarka Selvekerova, Martina Vaneckova, Lenka Zdrazilova-Dubska","doi":"10.1177/17588359251316224","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Cancer patients are particularly vulnerable during the COVID-19 pandemic. Vaccinations are essential in controlling the pandemic. However, due to their exclusion from clinical trials for COVID-19 vaccines, there is limited data on the vaccines' effectiveness and safety for this group.</p><p><strong>Objectives: </strong>We evaluated humoral (anti-S antibody) and cellular (T-cell) immune response in patients with solid cancer on systemic anticancer treatment versus healthy controls prime-vaccinated by the BNT162b2 COVID-19 mRNA vaccine.</p><p><strong>Methods: </strong>CoVigi was the phase IV prospective open-label non-randomized multicentric clinical trial evaluating anti-S and anti-N SARS-CoV-2 antibodies and SARS-CoV-2-specific T-cell response by IFN-γ-release assay in several time points during the prime COVID-19 mRNA vaccination (prior to the first vaccine dose, prior to the second dose, at 4-8 weeks, at 3 months, and 6 months after vaccination). Immune response was analyzed in the context of previous SARS-CoV-2 infection and anticancer therapy (chemotherapy (CT) + monoclonal antibodies (mAb), mAb, immune checkpoint inhibitors, tyrosine kinase inhibitors, and curative radiotherapy).</p><p><strong>Results: </strong>Among 204 patients with solid cancer and 73 healthy controls, 65% of SARS-CoV-2-naïve patients with cancer developed anti-S antibodies after the first vaccine dose, rising to 92% after the second dose. By 6 months, all BNT162b2-vaccinated patients with solid cancer developed antibody response. Patients treated with CT showed impaired both humoral and cellular immune response to BNT162b2 vaccination. Antibody levels in SARS-CoV-2-recovered patients were comparable to healthy controls. T-cell response peaked after the second dose of BNT162b2 and was not significantly impaired in solid cancer patients except those treated with CT.</p><p><strong>Conclusion: </strong>Immune response to BNT162b2 COVID-19 mRNA vaccine is substantially shaped by pre-vaccination COVID-19 infection. All patients with solid cancer on active anticancer therapy exhibited seroconversion after COVID-19 vaccination, although the extent of both humoral and cell immune response was substantially hampered in those treated by CT.</p><p><strong>Trial registration: </strong>EudraCT No. 2021-000566-14 (registration date February 17, 2021).</p>","PeriodicalId":23053,"journal":{"name":"Therapeutic Advances in Medical Oncology","volume":"17 ","pages":"17588359251316224"},"PeriodicalIF":4.3000,"publicationDate":"2025-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085753/pdf/","citationCount":"0","resultStr":"{\"title\":\"Patterns of SARS-CoV-2-specific humoral and cellular immune response in actively treated patients with solid cancer following prime BNT162b2 COVID-19 vaccination: results from phase IV CoVigi trial.\",\"authors\":\"Radka Lordick Obermannova, Iveta Selingerova, Regina Demlova, Dominika Okruhlicova, Jiri Nevrlka, Katerina Cerna-Pilatova, Kristina Greplova, Zdenka Cermakova, Dalibor Valik, Igor Kiss, Marketa Palacova, Alexandr Poprach, Hana Lejdarova, Sarka Selvekerova, Martina Vaneckova, Lenka Zdrazilova-Dubska\",\"doi\":\"10.1177/17588359251316224\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Cancer patients are particularly vulnerable during the COVID-19 pandemic. Vaccinations are essential in controlling the pandemic. However, due to their exclusion from clinical trials for COVID-19 vaccines, there is limited data on the vaccines' effectiveness and safety for this group.</p><p><strong>Objectives: </strong>We evaluated humoral (anti-S antibody) and cellular (T-cell) immune response in patients with solid cancer on systemic anticancer treatment versus healthy controls prime-vaccinated by the BNT162b2 COVID-19 mRNA vaccine.</p><p><strong>Methods: </strong>CoVigi was the phase IV prospective open-label non-randomized multicentric clinical trial evaluating anti-S and anti-N SARS-CoV-2 antibodies and SARS-CoV-2-specific T-cell response by IFN-γ-release assay in several time points during the prime COVID-19 mRNA vaccination (prior to the first vaccine dose, prior to the second dose, at 4-8 weeks, at 3 months, and 6 months after vaccination). Immune response was analyzed in the context of previous SARS-CoV-2 infection and anticancer therapy (chemotherapy (CT) + monoclonal antibodies (mAb), mAb, immune checkpoint inhibitors, tyrosine kinase inhibitors, and curative radiotherapy).</p><p><strong>Results: </strong>Among 204 patients with solid cancer and 73 healthy controls, 65% of SARS-CoV-2-naïve patients with cancer developed anti-S antibodies after the first vaccine dose, rising to 92% after the second dose. By 6 months, all BNT162b2-vaccinated patients with solid cancer developed antibody response. Patients treated with CT showed impaired both humoral and cellular immune response to BNT162b2 vaccination. Antibody levels in SARS-CoV-2-recovered patients were comparable to healthy controls. T-cell response peaked after the second dose of BNT162b2 and was not significantly impaired in solid cancer patients except those treated with CT.</p><p><strong>Conclusion: </strong>Immune response to BNT162b2 COVID-19 mRNA vaccine is substantially shaped by pre-vaccination COVID-19 infection. All patients with solid cancer on active anticancer therapy exhibited seroconversion after COVID-19 vaccination, although the extent of both humoral and cell immune response was substantially hampered in those treated by CT.</p><p><strong>Trial registration: </strong>EudraCT No. 2021-000566-14 (registration date February 17, 2021).</p>\",\"PeriodicalId\":23053,\"journal\":{\"name\":\"Therapeutic Advances in Medical Oncology\",\"volume\":\"17 \",\"pages\":\"17588359251316224\"},\"PeriodicalIF\":4.3000,\"publicationDate\":\"2025-05-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12085753/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Medical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/17588359251316224\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Medical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/17588359251316224","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
Patterns of SARS-CoV-2-specific humoral and cellular immune response in actively treated patients with solid cancer following prime BNT162b2 COVID-19 vaccination: results from phase IV CoVigi trial.
Background: Cancer patients are particularly vulnerable during the COVID-19 pandemic. Vaccinations are essential in controlling the pandemic. However, due to their exclusion from clinical trials for COVID-19 vaccines, there is limited data on the vaccines' effectiveness and safety for this group.
Objectives: We evaluated humoral (anti-S antibody) and cellular (T-cell) immune response in patients with solid cancer on systemic anticancer treatment versus healthy controls prime-vaccinated by the BNT162b2 COVID-19 mRNA vaccine.
Methods: CoVigi was the phase IV prospective open-label non-randomized multicentric clinical trial evaluating anti-S and anti-N SARS-CoV-2 antibodies and SARS-CoV-2-specific T-cell response by IFN-γ-release assay in several time points during the prime COVID-19 mRNA vaccination (prior to the first vaccine dose, prior to the second dose, at 4-8 weeks, at 3 months, and 6 months after vaccination). Immune response was analyzed in the context of previous SARS-CoV-2 infection and anticancer therapy (chemotherapy (CT) + monoclonal antibodies (mAb), mAb, immune checkpoint inhibitors, tyrosine kinase inhibitors, and curative radiotherapy).
Results: Among 204 patients with solid cancer and 73 healthy controls, 65% of SARS-CoV-2-naïve patients with cancer developed anti-S antibodies after the first vaccine dose, rising to 92% after the second dose. By 6 months, all BNT162b2-vaccinated patients with solid cancer developed antibody response. Patients treated with CT showed impaired both humoral and cellular immune response to BNT162b2 vaccination. Antibody levels in SARS-CoV-2-recovered patients were comparable to healthy controls. T-cell response peaked after the second dose of BNT162b2 and was not significantly impaired in solid cancer patients except those treated with CT.
Conclusion: Immune response to BNT162b2 COVID-19 mRNA vaccine is substantially shaped by pre-vaccination COVID-19 infection. All patients with solid cancer on active anticancer therapy exhibited seroconversion after COVID-19 vaccination, although the extent of both humoral and cell immune response was substantially hampered in those treated by CT.
Trial registration: EudraCT No. 2021-000566-14 (registration date February 17, 2021).
期刊介绍：
Therapeutic Advances in Medical Oncology is an open access, peer-reviewed journal delivering the highest quality articles, reviews, and scholarly comment on pioneering efforts and innovative studies in the medical treatment of cancer. The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in medical oncology, providing a forum in print and online for publishing the highest quality articles in this area. This journal is a member of the Committee on Publication Ethics (COPE).
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