COVID-19 吸附型灭活疫苗(CoronaVac)和额外剂量的 mRNA BNT162b2 疫苗在免疫力低下的成人与免疫力正常者中的免疫原性比较

Karim Yaqub Ibrahim, Raquel Megale Moreira, Carolina Ferreira dos Santos, Tânia Mara Varejão Strabelli, Juliana de Cássia Belizário, Maria Isabel de Moraes Pinto, Ana Karolina Barreto Berselli Marinho, Juliana Marquezi Pereira, Liliane Saraiva de Mello, Mauricio Cesar Ando, Vitor Gabriel Lopes da Silva, Paula Keiko Sato, Marcos Alves de Lima, João Italo Dias França, Ana Paula Loch, K. Miyaji, Vanessa Infante, A. Precioso, Ana Marli Christovam Sartori
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Adults with solid organ transplant (SOT), hematopoietic stem cell transplant, cancer, inborn immunity errors or rheumatic diseases were included in the IC group. Immunocompetent adults were used as control group for comparison. Participants received two CoronaVac doses within a 28-day interval. IC received two additional BNT162b2 doses and H received a third BNT162b2 dose (booster). Blood samples were collected at baseline, 28 days after each dose, pre-booster and at the trial end. We used three serological tests to detect antibodies to SARS-CoV-2 nucleocapsid (N), trimeric spike (S), and receptor binding domain (RBD). Outcomes included seroconversion rates (SCR), geometric mean titers (GMT) and GMT ratio (GMTR). A total of 241 IC and 100 H adults participated in the study. After two CoronaVac doses, IC had lower SCR than H: anti-N, 33.3% vs 79%; anti-S, 33.8% vs 86%, and anti-RBD, 48.5% vs 85%, respectively. 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摘要

摘要 免疫功能低下者接种 COVID-19 灭活疫苗的数据很少。本试验评估了两个剂量的CoronaVac和额外剂量的BNT162b2 mRNA疫苗在免疫功能低下(IC)和免疫功能正常(H)个体中的免疫原性。患有实体器官移植 (SOT)、造血干细胞移植、癌症、先天性免疫错误或风湿性疾病的成人被纳入 IC 组。免疫功能正常的成人作为对照组进行比较。参试者在28天的间隔内接受两次CoronaVac治疗。IC 组接受两次额外的 BNT162b2 剂量,H 组接受第三次 BNT162b2 剂量(加强剂)。我们分别在基线、每次用药后 28 天、加强剂量前和试验结束时采集了血样。我们使用了三种血清学检测方法来检测 SARS-CoV-2 核头壳(N)、三聚体尖峰(S)和受体结合域(RBD)抗体。结果包括血清转换率(SCR)、几何平均滴度(GMT)和GMT比值(GMTR)。共有241名IC成人和100名H成人参与了这项研究。两次服用 CoronaVac 后,IC 的 SCR 值低于 H:抗 N(33.3% 对 79%)、抗 S(33.8% 对 86%)和抗 RBD(48.5% 对 85%)。IC 的 GMT 值也低于 H:抗 N 值为 2.3 vs 15.1;抗 S 值为 58.8 vs 213.2 BAU/mL;抗 RBD 值为 22.4 vs 168.0 U/mL。在第 3 次和第 4 次服用 BNT162b2 后,IC 有明显的抗 S 和抗 RBD 血清转换,但仍低于第 3 次服用后的 H。强化后,IC 组的 GMT 有所上升,但仍低于 H 组。CoronaVac两剂免疫原性在IC组低于H组。BNT162b2异源强化剂增强了两组的免疫应答。
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Immunogenicity of COVID-19 adsorbed inactivated vaccine (CoronaVac) and additional doses of mRNA BNT162b2 vaccine in immunocompromised adults compared with immunocompetent persons
ABSTRACT Inactivated COVID-19 vaccines data in immunocompromised individuals are scarce. This trial assessed the immunogenicity of two CoronaVac doses and additional BNT162b2 mRNA vaccine doses in immunocompromised (IC) and immunocompetent (H) individuals. Adults with solid organ transplant (SOT), hematopoietic stem cell transplant, cancer, inborn immunity errors or rheumatic diseases were included in the IC group. Immunocompetent adults were used as control group for comparison. Participants received two CoronaVac doses within a 28-day interval. IC received two additional BNT162b2 doses and H received a third BNT162b2 dose (booster). Blood samples were collected at baseline, 28 days after each dose, pre-booster and at the trial end. We used three serological tests to detect antibodies to SARS-CoV-2 nucleocapsid (N), trimeric spike (S), and receptor binding domain (RBD). Outcomes included seroconversion rates (SCR), geometric mean titers (GMT) and GMT ratio (GMTR). A total of 241 IC and 100 H adults participated in the study. After two CoronaVac doses, IC had lower SCR than H: anti-N, 33.3% vs 79%; anti-S, 33.8% vs 86%, and anti-RBD, 48.5% vs 85%, respectively. IC also showed lower GMT than H: anti-N, 2.3 vs 15.1; anti-S, 58.8 vs 213.2 BAU/mL; and anti-RBD, 22.4 vs 168.0 U/mL, respectively. After the 3rd and 4th BNT162b2 doses, IC had significant anti-S and anti-RBD seroconversion, but still lower than H after the 3rd dose. After boosting, GMT increased in IC, but remained lower than in the H group. CoronaVac two-dose schedule immunogenicity was lower in IC than in H. BNT162b2 heterologous booster enhanced immune response in both groups.
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