Perez Marc Gonzalo, Coria Lorena M, Ceballos Ana, Rodriguez Juan Manuel, Lombardo Mónica E, Bruno Laura, Páez Córdoba Federico, Fascetto Cassero Clara G, Salvatori Melina, Rios Medrano Mayra, Fulgenzi Fabiana, Alzogaray María F, Mykietiuk Analía, Uriarte Ignacio Leandro, Itcovici Nicolás, Smith Casabella Tomás, Corral Gonzalo, Bruno Miriam, Roldán Oscar, Núñez Sebastián A, Cahn Florencia, Yerino Gustavo A, Bianchi Alejandra, Braem Virginia, Christmann Analía, Corradetti Santiago, Darraidou Martín C, Di Nunzio Lucila, Estrada Tatiana, López Castelo Rocío, Marchionatti Carla, Pitocco Lucila, Trias Uriarte Virgina, Wood Cristian, Zadoff Romina, Bues Florencia, Garrido Rosa M, Montomoli Emanuele, Manenti Alessandro, Demaría Agostina, Prado Lineia, Pueblas Castro Celeste, Saposnik Lucas, Geffner Jorge, Montes de Oca Federico, Vega Julio C, Fló Juan, Bonvehí Pablo, Cassará Jorge, Pasquevich Karina A, Cassataro Juliana
Hospital Militar Central, Ciudad Autónoma Buenos Aires (1426), Argentina; ARVAC Clinical Trial Study Group. Argentina, Buenos Aires (1426), Argentina.
Instituto de Investigaciones Biotecnológicas, Universidad Nacional de San Martín (UNSAM) - Consejo Nacional de Investigaciones Científicas y Técnicas (CONICET), San Martín (1650), Buenos Aires, Argentina; Escuela de Bio y Nanotecnologías (EByN), Universidad Nacional de San Martín, San Martín (1650), Buenos Aires, Argentina.
Vaccine. 2025 Apr 30;54:127045. doi: 10.1016/j.vaccine.2025.127045. Epub 2025 Apr 3.
A randomized, placebo-controlled, crossover, double-blind, phase II/III study was conducted to evaluate the immunogenicity, safety, and tolerability of a recombinant booster vaccine (ARVAC) containing the SARS-CoV-2 spike protein receptor binding domain in three versions: ARVAC, ARVAC, and ARVAC in adults with ≤3 previous SARS-CoV-2 booster doses. Primary endpoint was seroconversion rate of neutralizing antibodies compared to placebo and to a > 75 % seroconversion rate to vaccine antigen homologous variants. All vaccine versions significantly increased seroconversion rates to SARS-CoV-2 variants compared to placebo. In participants aged 18-60 years, all versions met the primary endpoint; in those over 60 years old, ARVAC and ARVAC met this endpoint. No vaccine-related serious adverse events were recorded, and most adverse events were mild. Plasma levels of anti-spike-specific IgG and anti-S1-specific IgA in saliva increased in participants receiving any vaccine. The increase in plasma neutralizing antibodies induced by the vaccine was independent of the number of previous booster doses (0, 1 or 2), the primary vaccine platform (adenovirus, single-dose adenovirus, mRNA, inactivated virus, heterologous vaccination, and virus-like particle [VLP]) and the history of previous COVID-19. The neutralizing Ab response induced by the vaccine in healthy participants was similar to that triggered in participants with underlying medical conditions associated with an increased risk of severe COVID-19. ARVAC induced high seroconversion rates (>90 %) against multiple variants and was superior to other ARVAC-versions. It increased neutralizing antibodies against SARS-CoV-2 variants (Ancestral, Gamma, Omicron, XBB and JN.1) and SARS-CoV-1. (NCT05752201).
开展了一项随机、安慰剂对照、交叉、双盲的II/III期研究，以评估一种含有三种版本严重急性呼吸综合征冠状病毒2（SARS-CoV-2）刺突蛋白受体结合域的重组加强疫苗（ARVAC）在既往接受SARS-CoV-2加强剂量≤3剂的成年人中的免疫原性、安全性和耐受性。主要终点是与安慰剂相比的中和抗体血清转化率，以及对疫苗抗原同源变体的血清转化率>75%。与安慰剂相比，所有疫苗版本均显著提高了对SARS-CoV-2变体的血清转化率。在18至60岁的参与者中，所有版本均达到主要终点；在60岁以上的参与者中，ARVAC和ARVAC达到了该终点。未记录到与疫苗相关的严重不良事件，且大多数不良事件为轻度。接受任何疫苗的参与者血浆中抗刺突特异性IgG水平和唾液中抗S1特异性IgA水平均升高。疫苗诱导的血浆中和抗体增加与既往加强剂量的数量（0、1或2）、主要疫苗平台（腺病毒、单剂量腺病毒、信使核糖核酸、灭活病毒、异源疫苗接种和病毒样颗粒[VLP]）以及既往新冠病毒病病史无关。健康参与者中疫苗诱导的中和抗体反应与有与严重新冠病毒病风险增加相关的基础疾病的参与者中引发的反应相似。ARVAC诱导针对多种变体的高血清转化率（>90%），且优于其他ARVAC版本。它增加了针对SARS-CoV-2变体（原始株、伽马株、奥密克戎株、XBB和JN.1）和SARS-CoV-1的中和抗体。（临床试验注册号：NCT05752201）
