Lemos-Pérez Gilda, Barrese-Pérez Yinet, Chacón-Quintero Yahima, Uranga-Piña Rolando, Avila-Albuerne Yisel, Figueroa-García Iglermis, Calderín-Marín Osaida, Gómez-Vázquez Martha M, Piñera-Martínez Marjoris, Chávez-Valdés Sheila, Martínez-Rosales Ricardo, Ávila-Díaz Lismary, Vázquez-Arteaga Amalia, González-Formental Hany, Freyre-Corrales Giselle, Coizeau-Rodríguez Edelgis, Limonta-Fernández Miladys, Ayala-Avila Marta, Martínez-Díaz Eduardo, Pimentel-Vazquez Eulogio, Guillen Gerardo
Center for Genetic Engineering and Biotechnology (CIGB), P.O. Box 6162, La Habana 10600, Cuba.
National Coordinating Center for Clinical Trials (CENCEC), La Habana 11300, Cuba.
Vaccines (Basel). 2024 Sep 1;12(9):1001. doi: 10.3390/vaccines12091001.
A phase 1-2, prospective, multicenter, randomized, open-label clinical trial (Code RPCEC00000382), with parallel groups, involving 1161 participants, was designed to assess the safety and immunogenicity of two Cuban COVID-19 vaccines (Mambisa and Abdala) in boosting COVID-19 immunity of convalescent adults after receiving one dose of either vaccine. The main safety outcome was severe vaccination adverse events occurring in <5% of vaccinees. Main immunogenicity success endpoints were a ≥4-fold anti-RBD IgG seroconversion or a ≥20% increase in ACE2-RBD inhibitory antibodies in >55% of vaccinees in Phase 1 and >70% in Phase 2. Neutralizing antibody titers against SARS-CoV-2 variants were evaluated. Both vaccines were safe-no deaths or severe adverse events occurred. Mild intensity adverse events were the most frequent (>73%); headaches predominated for both vaccines. Phase 1 responders were 83.3% ( = 0.0018) for Abdala. Mambisa showed similar results. Phase 2 responders were 88.6% for Abdala ( < 0.0001) and 74.2% for Mambisa ( = 0.0412). In both phases, anti-RBD IgG titers, inhibition percentages and neutralizing antibody titers increased significantly after the booster dose. Both vaccines were safe and their immunogenicity surpassed the study endpoints.
一项1-2期前瞻性多中心随机开放标签临床试验（代码RPCEC00000382），采用平行组设计，纳入1161名参与者，旨在评估两种古巴新冠疫苗（曼比萨和阿卜杜拉）在增强已接种一剂这两种疫苗之一的康复期成年人的新冠免疫力方面的安全性和免疫原性。主要安全性结局是疫苗接种者中发生严重不良事件的比例<5%。主要免疫原性成功终点是在第1阶段>55%的疫苗接种者和第2阶段>70%的疫苗接种者中，抗受体结合域（RBD）免疫球蛋白G（IgG）血清转化率≥4倍或血管紧张素转换酶2（ACE2）-RBD抑制性抗体增加≥20%。评估了针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）变体的中和抗体滴度。两种疫苗均安全——未发生死亡或严重不良事件。轻度不良事件最为常见（>73%）；两种疫苗中头痛最为突出。阿卜杜拉疫苗在第1阶段的应答者为83.3%（ = 0.0018）。曼比萨疫苗显示出类似结果。阿卜杜拉疫苗在第2阶段的应答者为88.6%（ < 0.0001），曼比萨疫苗为74.2%（ = 0.0412）。在两个阶段，加强剂量后抗RBD IgG滴度、抑制百分比和中和抗体滴度均显著增加。两种疫苗均安全，其免疫原性超过了研究终点。
