International Journal of Infectious Diseases (Jan 2023)

Open-label phase I/II clinical trial of SARS-CoV-2 receptor binding domain-tetanus toxoid conjugate vaccine (FINLAY-FR-2) in combination with receptor binding domain-protein vaccine (FINLAY-FR-1A) in children

  • Rinaldo Puga-Gómez,
  • Yariset Ricardo-Delgado,
  • Chaumey Rojas-Iriarte,
  • Leyanis Céspedes-Henriquez,
  • Misleidys Piedra-Bello,
  • Dania Vega-Mendoza,
  • Noelvia Pestana Pérez,
  • Beatriz Paredes-Moreno,
  • Meiby Rodríguez-González,
  • Carmen Valenzuela-Silva,
  • Belinda Sánchez-Ramírez,
  • Laura Rodríguez-Noda,
  • Rocmira Pérez-Nicado,
  • Raul González-Mugica,
  • Tays Hernández-García,
  • Talía Fundora-Barrios,
  • Martha Dubet Echevarría,
  • Juliet María Enriquez-Puertas,
  • Yenicet Infante-Hernández,
  • Ariel Palenzuela-Díaz,
  • Evelyn Gato-Orozco,
  • Yanet Chappi-Estévez,
  • Julio Cesar Francisco-Pérez,
  • Miladi Suarez-Martinez,
  • Ismavy C. Castillo-Quintana,
  • Sonsire Fernandez-Castillo,
  • Yanet Climent-Ruiz,
  • Darielys Santana-Mederos,
  • Yanelda García-Vega,
  • María Eugenia Toledo-Romani,
  • Delaram Doroud,
  • Alireza Biglari,
  • Yury Valdés-Balbín,
  • Dagmar García-Rivera,
  • Vicente Vérez-Bencomo,
  • María Elena Mesa-Herrera,
  • Yarmila García-Cristiá,
  • Leonor Verdecia-Sánchez,
  • Rafael del Valle Rodríguez,
  • Yudalvies Oquendo-de la Cruz,
  • Daysi Álvarez-Montalvo,
  • Randy Grillo-Fortún,
  • Liset López-González,
  • Omaida Fonte Galindo,
  • Yeseni Reyes-González,
  • Ana Beatriz González-Álvarez,
  • Linet Gorrita-Mora,
  • Rodrigo Valera-Fernández,
  • Ivis Ontivero-Pino,
  • Marisel Martínez-Pérez,
  • Esperanza Caballero-Gonzalez,
  • Aniurka Garcés-Hechavarría,
  • Dayle Martínez-Bedoya,
  • Maite Medina-Nápoles,
  • Yeney Regla Domínguez-Pentón,
  • Yadira Cazañas-Quintana,
  • Thais Fundora Barrios,
  • Diana R. Hernández Fernández,
  • Gretchen Bergado-Báez,
  • Ivette Orosa-Vazquez,
  • Franciscary Pi-Estopiñan,
  • Marianniz Díaz-Hernández,
  • Otto Cruz-Sui,
  • Enrique Noa-Romero,
  • Arilia García-López,
  • Sandra Rivadereira Muro,
  • Gerardo Baro-Roman

Journal volume & issue
Vol. 126
pp. 164 – 173

Abstract

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Objectives: To evaluate a heterologous vaccination scheme in children 3-18 years old (y/o) combining two SARS-CoV-2r- receptor binding domain (RBD)protein vaccines. Methods: A phase I/II open-label, adaptive, and multicenter trial evaluated the safety and immunogenicity of two doses of FINLAY-FR-2 (subsequently called SOBERANA 02) and the third heterologous dose of FINLAY-FR-1A (subsequently called SOBERANA Plus) in 350 children 3-18 y/o in Havana Cuba. Primary outcomes were safety (phase I) and safety/immunogenicity (phase II) measured by anti-RBD immunoglobulin (Ig)G enzyme-linked immunoassay (ELISA), molecular and live-virus neutralization titers, and specific T-cells response. A comparison with adult immunogenicity and predictions of efficacy were made based on immunological results. Results: Local pain was the unique adverse event with frequency >10%, and none was serious neither severe. Two doses of FINLAY-FR-2 elicited a humoral immune response similar to natural infection; the third dose with FINLAY-FR-1A increased the response in all children, similar to that achieved in vaccinated young adults. The geometric mean (GMT) neutralizing titer was 173.8 (95% confidence interval [CI] 131.7; 229.5) vs Alpha, 142 (95% CI 101.3; 198.9) vs Delta, 24.8 (95% CI 16.8; 36.6) vs Beta and 99.2 (95% CI 67.8; 145.4) vs Omicron. Conclusion: The heterologous scheme was safe and immunogenic in children 3-18 y/o. Trial registry: https://rpcec.sld.cu/trials/RPCEC00000374

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