肺癌患者感染SARS-CoV-2和COVID-19的严重并发症的风险增加，但关于这些患者抗SARS-CoV-2疫苗的有效性的信息很少。我们旨在评估COVID-19疫苗在这一人群中的安全性和免疫原性。这项前瞻性、全国性的SOLID子研究招募了已完成COVID-19疫苗全程接种的肺癌成年患者。使用化学发光微粒免疫分析法定量评估最后一剂疫苗接种后两周和六个月时的血清抗SARS-CoV-2 IgG抗体水平。估计与人口统计学和临床因素与疫苗接种后抗体阴性率之间的关联的多元逻辑回归比值。共招募了1973名肺癌患者。大多数患者为第四期疾病（66%）并正在接受积极的癌症治疗（82.7%）。与未接受积极癌症治疗的患者相比，在接种完全疫苗后抗SARS-CoV-2 IgG抗体阴性率的概率没有显著差异（p = 0.396）。免疫疗法或口服靶向治疗以及接种mRNA-1273 COVID-19疫苗与接种后抗体阳性率增加的概率独立相关。所有患者中，1405人接受了第二剂疫苗，接种后两周观察到93.6%的患者抗体滴度水平较高。六个月后，多元逻辑回归分析显示，疫苗接种后状态表现≥2与接种完全疫苗后抗体阴性率较高的概率独立相关，比值比为4.15。另一方面，接受化疗或口服靶向治疗以及接种mRNA-1273疫苗与接种完全疫苗后抗体阴性率较低的概率独立相关，比值比为0.52、0.37和0.34。肺癌患者在完成疫苗接种后可以安全地产生强烈的抗SARS-CoV-2免疫应答，无论接受何种癌症治疗。NCT04407143。版权所有©2023 The Authors，由Elsevier B.V.出版。保留所有权利。

Patients with lung cancer are at increased risk of SARS-CoV-2 infection and severe complications from COVID-19, but information on the efficacy of anti-SARS-CoV-2 vaccine in these patients is scarce. We aimed at evaluating the safety and immunogenicity of COVID-19 vaccines in this population.The prospective, nationwide SOLID substudy, enrolled adults with lung cancer who were fully vaccinated against COVID-19. Serum anti-SARS-CoV-2 IgG antibody levels were quantitatively assessed two weeks and six months after receipt of the last dose using a chemiluminescent microparticle immunoassay. Multivariate odds ratios for the association between demographic and clinical factors and seronegativity after vaccination were estimated.1973 lung cancer patients were enrolled. Most patients had stage IV disease (66%) and were receiving active cancer treatment (82.7%). No significant differences were found in the probability of being seronegative for anti-SARS-CoV-2 IgG antibodies after full vaccination between patients who were receiving active cancer treatment and those who were not (p = 0.396). The administration of immunotherapy or oral targeted therapy and immunization with mRNA-1273 COVID-19 vaccine were factors independently associated with increased odds of being seropositive after vaccination. From all patients, 1405 received the second dose of vaccine and high levels of antibody titers were observed in 93.6% of patients two weeks after second dose. At six months, multivariate logistic regression analysis showed that performance status ≥ 2 was independently associated with a higher probability of being seronegative after full vaccination with an OR 4.15. On the other hand, received chemotherapy or oral target therapy and vaccination with mRNA-1273 were a factor independently associated with lower odds of being seronegative after full vaccination with an OR 0.52, 0.37 and 0.34, respectively.Lung cancer patients can safely achieve a strong immune response against SARS-CoV-2 after full vaccination, regardless of the cancer treatment received.NCT04407143.Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.