García-Rivera Dagmar, Puga-Gómez Rinaldo, Fernández-Castillo Sonsire, Paredes-Moreno Beatriz, Ricardo-Delgado Yariset, Rodríguez-González Meiby, Silva Carmen Valenzuela, Pérez-Nicado Rocmira, Rodríguez-Noda Laura, Santana-Mederos Darielys, Climent-Ruiz Yanet, Noa-Romero Enrique, Cruz-Sui Otto, Sánchez-Ramírez Belinda, Hernández-García Tays, Palenzuela-Diaz Ariel, Martínez-Perez Marisel, García-López Arilia, Valdés-Balbín Yury, Vérez-Bencomo Vicente G
Finlay Vaccine Institute, Av. 21 #19810, Atabey, Playa, Havana 11600, Cuba.
Pediatric Hospital "Juan Manuel Márquez". Av. 31, Marianao, Havana 11400, Cuba.
Vaccine X. 2024 Dec 6;22:100595. doi: 10.1016/j.jvacx.2024.100595. eCollection 2025 Jan.
The heterologous three-dose schedule of the protein subunit anti-COVID-19 SOBERANA®02 and SOBERANA® Plus vaccines has proved its safety, immunogenicity and efficacy in pediatric population, but durability of immunogenicity is not yet dilucidated. This study reports the safety and durability of the humoral and cellular responses in children and adolescents 5-7 months after receiving the heterologous vaccine schedule of SOBERANA® 02 and SOBERANA® Plus.
Children participating in a phase I/II clinical trial were followed-up for 5-7 months after the last dose. They were clinically examined by medical doctors, and their parents were interviewed searching for long-term adverse events. Blood samples were collected to evaluate the duration of humoral and cellular immune responses. Sera were tested for the presence of SARS-CoV-2 nucleocapsid (N) protein.
There were no reports of severe adverse events such as coagulation disorders, myocarditis, or pericarditis. None of the participants who withdrew from the trial during the follow-up period did so due to post-vaccination adverse events. The humoral response waned in time for N-negative children, but levels of specific and neutralizing antibodies remained similar to those attained after the second dose of SOBERANA® 02 in the heterologous schedule. Neutralizing antibodies against SARS-CoV-2 D614G and omicron BA.1 were detected 5-7 months post-vaccination. RBD-specific IFN-γ secreting cells showed no significant change compared to levels following primary immunization, in both N-negative and N-positive children.
The vaccination regimen was safe over time, and both humoral and cellular immunity persisted in the vaccinated population aged 3-18 years, 5-7 months after receiving the heterologous SOBERANA® 02 and SOBERANA® Plus vaccine schedule.Trial registry: https://rpcec.sld.cu/trials/RPCEC00000374-En.
蛋白亚单位抗新冠病毒SOBERANA®02和SOBERANA® Plus疫苗的异源三剂次接种方案已在儿童人群中证明了其安全性、免疫原性和有效性，但免疫原性的持久性尚未阐明。本研究报告了儿童和青少年在接种SOBERANA® 02和SOBERANA® Plus异源疫苗方案5至7个月后的体液和细胞免疫反应的安全性及持久性。
参与一项I/II期临床试验的儿童在最后一剂接种后随访5至7个月。由医生进行临床检查，并与他们的父母进行访谈以寻找长期不良事件。采集血样以评估体液和细胞免疫反应的持续时间。检测血清中是否存在新冠病毒核衣壳（N）蛋白。
未报告有凝血障碍、心肌炎或心包炎等严重不良事件。在随访期间退出试验的参与者中，没有一人是因为接种疫苗后的不良事件而退出。对于N阴性儿童，体液反应随时间减弱，但特异性抗体和中和抗体水平仍与异源接种方案中第二剂SOBERANA® 02接种后所达到的水平相似。接种疫苗5至7个月后检测到针对新冠病毒D614G和奥密克戎BA.1的中和抗体。在N阴性和N阳性儿童中，RBD特异性分泌IFN-γ的细胞与初次免疫后的水平相比均无显著变化。
随着时间推移，该疫苗接种方案是安全的，并且在3至18岁的接种人群中，接种SOBERANA® 02和SOBERANA® Plus异源疫苗方案5至7个月后，体液免疫和细胞免疫均持续存在。试验注册：https://rpcec.sld.cu/trials/RPCEC00000374-En 。
