SOBERANA02已在比较同源与异源时间表的I期和IIa期研究中进行了评估(这一个,包括SOBERANAPlus)。这里,我们报告了免疫原性的结果,安全,和SOBERANA02在成人两剂量或三剂量异源方案中的反应原性。
IIb阶段是平行的,多中心,适应性,双盲,随机化,和安慰剂对照试验。年龄在19-80岁之间的受试者(n=810)被随机分配接受两剂与破伤风类毒素(SOBERANA02)结合的SARS-CoV-2RBD和第三剂二聚体RBD(SOBERANAPlus),间隔28天;评估了两批生产的SOBERANA02活性成分。主要结果是抗RBD免疫球蛋白G(IgG)浓度≥4倍的血清转化受试者的百分比。次要结果是安全性,反应原性,和中和抗体。
接种两剂后,接种疫苗的血清转化率为76.3%,第三剂SOBERANAPlus后为96.8%(安慰剂组为7.3%)。检测到针对D614G和关注变体(VOCs)α的中和IgG抗体,Beta,Delta,还有Omicron.Specific,第三次给药后7~8个月检测功能性抗体.与疫苗接种相关的严重不良事件(AE)的频率非常低(0.1%)。局部疼痛是最常见的AE。
两种剂量的SOBERANA02在成人中是安全和免疫原性的。与SOBERANAPlus的异源组合增加了中和抗体,在第三次给药后7-8个月可检测到。
https://rpcec。sld.cu/trials/RPCEC00000347基金:这项工作得到了Finlay疫苗研究所的支持,BioCubaFarma,和CienciayTécnica国家基金会(FONCI-CITMA-Cuba,合同2020-20)。
SOBERANA 02 has been evaluated in phase I and IIa studies comparing homologous versus heterologous schedule (this one, including SOBERANA Plus). Here, we report results of immunogenicity, safety, and reactogenicity of SOBERANA 02 in a two- or three-dose heterologous scheme in adults.
Phase IIb was a parallel, multicenter, adaptive, double-blind, randomized, and placebo-controlled trial. Subjects (n = 810) aged 19-80 years were randomized to receive two doses of SARS-CoV-2 RBD conjugated to tetanus toxoid (SOBERANA 02) and a third dose of dimeric RBD (SOBERANA Plus) 28 days apart; two production batches of active ingredients of SOBERANA 02 were evaluated. Primary outcome was the percentage of seroconverted subjects with ≥4-fold the anti-RBD immunoglobulin G (IgG) concentration. Secondary outcomes were safety, reactogenicity, and neutralizing antibodies.
Seroconversion rate in vaccinees was 76.3% after two doses and 96.8% after the third dose of SOBERANA Plus (7.3% in the placebo group). Neutralizing IgG antibodies were detected against D614G and variants of concern (VOCs) Alpha, Beta, Delta, and Omicron. Specific, functional antibodies were detected 7-8 months after the third dose. The frequency of serious adverse events (AEs) associated with vaccination was very low (0.1%). Local pain was the most frequent AE.
Two doses of SOBERANA 02 were safe and immunogenic in adults. The heterologous combination with SOBERANA Plus increased neutralizing antibodies, detectable 7-8 months after the third dose.
https://rpcec.sld.cu/trials/RPCEC00000347 FUNDING: This work was supported by Finlay Vaccine Institute, BioCubaFarma, and the Fondo Nacional de Ciencia y Técnica (FONCI-CITMA-Cuba, contract 2020-20).