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Efficacy and Safety of SOBERANA 02, a COVID-19 conjugate vaccine in heterologous three doses combination

Maria Eugenia Toledo-Romani, Mayra Garcia-Carmenate, Carmen Valenzuela Silva, Waldemar Baldoquin-Rodriguez, Marisel Martinez Perez, Meiby C Rodriguez Gonzalez, Beatriz Paredes Moreno, Ivis Mendoza Hernandez, Raul Gonzalez-Mujica Romero, Oscar Samon Tabio, Pablo Velazco Villares, Juan Pablo Bacallao Castillo, Ernesto Licea Martin, Misladys Rodriguez Ortega, Nuris Liem Herrera Marrero, Esperanza Caballero Gonzalez, Liudmila Ibelin Egues Torres, Reinaldo Duarte Gonzalez, Serguey Garcia Blanco, Suzette Perez Cabrera, Santos Huete Ferreira, Kirenia Idalmis Idalmis Cisnero, Omaida Fonte Galindo, Dania Melia Perez, Ivonne Rojas Remedios, Sonsire Fernandez Castillo, Yanet Climent Ruiz, Yury Valdes Balbin, Dagmar Garcia Rivera, Vicente Verez-Bencomo
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Background: SOBERANA 02 is a COVID19 conjugate vaccine (recombinant RBD conjugated to tetanus toxoid). Phase 1 and 2 clinical trials demonstrated its high immunogenicity, promoting neutralizing IgG together with specific T-cell response. A third dose of SOBERANA Plus (SARS-CoV-2 RBD-dimer) further increased the specific anti-RBD neutralizing antibodies. Methods: In a randomized, double-blinded, placebo-controlled, phase 3 trial we randomly assigned 44 031 participants, aged 19-80 years to three groups in a 1:1:1 ratio to receive 28 days apart either a) two doses of 25 microg SOBERANA 02, or b) two doses of 25 microg SOBERANA 02 followed by a third dose of 50 microg SOBERANA Plus, or c) two doses of placebo. Reported study endpoints are vaccine efficacy (VE) evaluated through laboratory-confirmed symptomatic COVID-19 cases and safety. During the trial, the SARS CoV-2 isolates in Havana were predominantly (beta 74.0 %) and shift gradually to delta (100%). Results: Two doses of SOBERANA 02 protects against symptomatic COVID-19: 43 cases in the two-dose group (14 371) vs. 155 in the placebo group (14 403), VE 71.0%, adjusted (CI 95%58.9-79.1). The heterologous three dose combination with SOBERANA Plus protected against symptomatic COVID-19: 15 cases in the vaccine groups (13 833) vs. 155 in the placebo group (14 303), VE 92.4%, adjusted (CI 95% 86.9-95.6%). For two-dose schedule VE against severe COVID-19 was 63.0% and for death 59.0%; for heterologous three-dose schedule, 100% in both cases. Conclusions: This is the first phase 3 study of a three-dose, heterologous vaccine combination against SARS-CoV-2. Two doses of the conjugate vaccine SOBERANA 02 was safe and attained efficacy of 71.0% in adults population 19-80 y/o; incorporating SOBERANA Plus after two doses of SOBERANA 02, increased efficacy from 71.0 % to 92.4% (Clinical Trials IFV/COR/09 number, RPCEC00000354.)

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Publicado en el sitio 2021-11-02 09:39:01

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