Safety and immunogenicity of the FINLAY-FR-1A vaccine in COVID-19 convalescent participants: an open-label phase 2a and double-blind, randomised, placebo-controlled, phase 2b, seamless, clinical trial

Ochoa-Azze, Rolando Felipe; Monteagudo, Arturo Chang; Climent-Ruíz, Yanet; Macías-Abraham, Consuelo; Valenzuela-Silva, Carmen; García-García, María de los Ángeles; Jerez-Barceló, Yanet; Triana-Marrero, Yenisey; Ruiz-Villegas, Laura; Rodríguez-Prieto, Luis Dairon; Guerra-Chaviano, Pedro Pablo; Sánchez-Ramírez, Belinda; Hernández-García, Tays; Orosa-Vázquez, Ivette; Díaz-Hernández, Marianniz; Chiodo, Fabrizio; Calcagno, Andrea; Ghisetti, Valeria; Rodríguez-Acosta, Mireida; Noa-Romero, Enrique; Enríquez-Puertas, Juliet; Ortega-León, Darién; Valdivia-Álvarez, Irinia; Delahanty-Fernández, Aurora; Palenzuela-Díaz, Ariel; Rodríguez-Noda, Laura; Gonzalez-Mugica, Raul; Valdés-Balbín, Yury; García-Rivera, Dagmar; Vérez-Bencomo, Vicente

doi:10.1016/s2213-2600(22)00100-x

Cited by 23 publications

(17 citation statements)

References 32 publications

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“… 4 , 8 SOBERANA-Plus antigen is a dimeric RBD (50 μg) adsorbed on 1250 μg alumina. 15 , 16 The placebo contained SOBERANA-02 ingredients except the active principle. All were stored at 2–8 °C and distributed daily to the clinical sites.…”

Section: Methodsmentioning

confidence: 99%

Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial

Toledo-Romaní¹,

García-Carmenate²,

Valenzuela-Silva³

et al. 2023

The Lancet Regional Health - Americas

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Section: Methodsmentioning

confidence: 99%

Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial

Toledo-Romaní¹,

García-Carmenate²,

Valenzuela-Silva³

et al. 2023

The Lancet Regional Health - Americas

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“…4, 8 SOBERANA-Plus antigen is a dimeric RBD (50 μg) adsorbed on 1250 μg alumina. 14, 15 The placebo contained SOBERANA-02 ingredients except the active principle. All were stored at 2-8°C and distributed daily to the clinical sites.…”

Section: Methodsmentioning

confidence: 99%

Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-PLUS: double-blind, randomised, placebo-controlled phase 3 clinical trial

Toledo-Romaní

García-Carmenate²,

Valenzuela-Silva

et al. 2021

Preprint

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BackgroundSOBERANA 02 is a COVID-19 conjugate vaccine (recombinant RBD conjugated to tetanus toxoid). Phase 1 and 2 clinical trials demonstrated its high immunogenicity, promoting neutralizing IgG and specific T-cell response. A third dose, of SOBERANA Plus (RBD-dimer), further increased the specific anti-RBD neutralizing antibodies.MethodsIn a randomized, double-blind, placebo-controlled, phase-3 trial (https://rpcec.sld.cu/trials/RPCEC00000354-En) we randomly assigned 44 031 participants, aged 19–80 years to three groups to receive a) two doses, SOBERANA 02, or b) two doses, SOBERANA 02 and a third dose, SOBERANA Plus, or c) placebo. Study endpoints are vaccine efficacy (VE) evaluated through confirmed symptomatic COVID-19 and safety. During the trial, the SARS CoV-2 isolates in Havana were 74.0 % β, shifting gradually to 100% δ.ResultsTwo doses of SOBERANA 02 protected 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 increased the protection: 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 the two-dose schedule, VE against severe COVID-19 was 63.0% and for death, 59.0%; for the heterologous three-dose schedule, VE was 100% in both cases.ConclusionsThis is the first phase-3 study of a three-dose, heterologous COVID-19 vaccine. Two doses of SOBERANA 02 were safe and attained efficacy of 71.0% in the adult population 19-80 y/o; incorporating SOBERANA Plus increased efficacy from 71.0 % to 92.4%.

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“…FINLAY-FR-2 (Soberana 02) is a protein subunit vaccine conjugated to the tetanus toxoid carrier protein and has shown potential in preclinical studies 2,3 and phase 1, 2, and 3 trials. [4][5][6][7] FINLAY-FR-1A (Soberana Plus), which is an RBD dimer without conjugation, has enhanced neutralization response in individuals recovering from COVID-19 8 and, when used as the third dose to FINLAY-FR-2, induced neutralizing anti-RBD immunoglobulin G (IgG) antibodies (eMethods in Supplement 2). 4 On approval of the first sets of COVID-19 vaccines, governments all over the world rushed to place orders for supplies, based on the assumed effectiveness and relevance of the vaccine for their populations.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine

et al. 2023

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ImportanceThe protein-based SARS-CoV-2 vaccines FINLAY-FR-2 (Soberana 02) and FINLAY-FR-1A (Soberana Plus) showed good safety and immunogenicity in phase 1 and 2 trials, but the clinical efficacy of the vaccine remains unknown.ObjectiveTo evaluate the efficacy and safety of a 2-dose regimen of FINLAY-FR-2 (cohort 1) and a 3-dose regimen of FINLAY-FR-2 with FINLAY-FR-1A (cohort 2) in Iranian adults.Design, Setting, and ParticipantsA multicenter, randomized, double-blind, placebo-controlled, phase 3 trial was conducted at 6 cities in cohort 1 and 2 cities in cohort 2. Participants included individuals aged 18 to 80 years without uncontrolled comorbidities, coagulation disorders, pregnancy or breastfeeding, recent immunoglobulin or immunosuppressive therapy, and clinical presentation or laboratory-confirmed COVID-19 on enrollment. The study was conducted from April 26 to September 25, 2021.InterventionsIn cohort 1, 2 doses of FINLAY-FR-2 (n = 13 857) or placebo (n = 3462) were administered 28 days apart. In cohort 2, 2 doses of FINLAY-FR-2 plus 1 dose of FINLAY-FR-1A (n = 4340) or 3 placebo doses (n = 1081) were administered 28 days apart. Vaccinations were administered via intramuscular injection.Main Outcomes and MeasuresThe primary outcome was polymerase chain reaction–confirmed symptomatic COVID-19 infection at least 14 days after vaccination completion. Other outcomes were adverse events and severe COVID-19. Intention-to-treat analysis was performed.ResultsIn cohort 1 a total 17 319 individuals received 2 doses and in cohort 2 5521 received 3 doses of the vaccine or placebo. Cohort 1 comprised 60.1% men in the vaccine group and 59.1% men in the placebo group; cohort 2 included 59.8% men in the vaccine group and 59.9% in the placebo group. The mean (SD) age was 39.3 (11.9) years in cohort 1 and 39.7 (12.0) years in cohort 2, with no significant difference between the vaccine and placebo groups. The median follow-up time in cohort 1 was 100 (IQR, 96-106) days and, in cohort 2, 142 (137-148) days. In cohort 1, 461 (3.2%) cases of COVID-19 occurred in the vaccine group and 221 (6.1%) in the placebo group (vaccine efficacy: 49.7%; 95% CI, 40.8%-57.3%) vs 75 (1.6%) and 51 (4.3%) in cohort 2 (vaccine efficacy: 64.9%; 95% CI, 49.7%-59.5%). The incidence of serious adverse events was lower than 0.1%, with no vaccine-related deaths.Conclusions and RelevanceIn this multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of the efficacy and safety of FINLAY-FR-2 and FINLAY-FR-1A, 2 doses of FINLAY-FR-2 plus the third dose of FINLAY-FR-1A showed acceptable vaccine efficacy against symptomatic COVID-19 as well as COVID-19–related severe infections. Vaccination was generally safe and well tolerated. Therefore, Soberana may have utility as an option for mass vaccination of the population, especially in resource-limited settings, because of its storage condition and affordable price.Trial Registrationisrctn.org Identifier: IRCT20210303050558N1

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Safety and immunogenicity of the FINLAY-FR-1A vaccine in COVID-19 convalescent participants: an open-label phase 2a and double-blind, randomised, placebo-controlled, phase 2b, seamless, clinical trial

Cited by 23 publications

References 32 publications

Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial

Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-Plus: a double-blind, randomised, placebo-controlled phase 3 clinical trial

Safety and efficacy of the two doses conjugated protein-based SOBERANA-02 COVID-19 vaccine and of a heterologous three-dose combination with SOBERANA-PLUS: double-blind, randomised, placebo-controlled phase 3 clinical trial

Efficacy and Safety of a Protein-Based SARS-CoV-2 Vaccine

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