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

Eugenia-Toledo-Romani, Maria; Carmenate, Mayra García; Valenzuela-Silva, Carmen; Rodríguez, Waldemar Baldoquín; Martínez-Pérez, Marisel; Rodríguez-González, Meiby; Paredes-Moreno, Beatriz; Mendoza-Hernández, Ivis; Gonzalez-Mugica, Raul; Samón-Tabío, Oscar; Velazco-Villares, Pablo; Bacallao-Castillo, Juan Pablo; Licea-Martín, Ernesto; Rodríguez-Ortega, Misladys; Herrera-Marrero, Nuris; Caballero-González, Esperanza; Egües-Torres, Liudmila; Duartes-González, Reinaldo; García-Blanco, Serguey; Pérez-Cabrera, Suzette; Huete-Ferreira, Santos; Idalmis-Cisnero, Kirenia Idalmis-Cisnero; Fonte-Galindo, Omayda; Meliá-Pérez, Dania; Rojas-Remedios, Ivonne; Doroud, Delaram; Gouya, Mohammad Mehdí; Biglari, Alireza; Stuyft, Patrick Van der; Fernández-Castillo, Sonsire; Climent-Ruíz, Yanet; Valdés-Balbín, Yury; García-Rivera, Dagmar; Vérez-Bencomo, Vicente

doi:10.2139/ssrn.4174293

Cited by 2 publications

(2 citation statements)

References 20 publications

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“…The RBD is thought to transiently sample an "up" conformation compatible with Ace2 binding, which exposes neutralizing epitopes including some that may cross-protect against other coronaviruses (22)(23)(24)(25)(26). Consistent with these observations, the native RBD sequence is an effective vaccine (27,28). However, the RBD contacts other domains in the context of the full-length (FL)-spike protein, contains nonneutralizing epitopes, and may not stably present all neutralizing epitopes.…”

Section: Introductionmentioning

confidence: 94%

Design of the SARS-CoV-2 RBD vaccine antigen improves neutralizing antibody response

et al. 2022

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The receptor binding domain (RBD) of the SARS-CoV-2 spike protein is the primary target of neutralizing antibodies and is a component of almost all current vaccines. Here, RBD immunogens were created with stabilizing amino acid changes that improve the neutralizing antibody response, as well as characteristics for production, storage, and distribution. A computational design and in vitro screening platform identified three improved immunogens, each with approximately nine amino acid changes relative to the native RBD sequence, and four key changes conserved between immunogens. The changes are adaptable to all vaccine platforms and compatible with mutations in emerging variants of concern. The immunogens elicit higher levels of neutralizing antibodies than native RBD, focus the immune response to structured neutralizing epitopes, and have increased production yields and thermostability. Incorporating these variant-independent amino acid changes in next-generation COVID vaccines may enhance the neutralizing antibody response and lead to longer duration and broader protection.

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Section: Introductionmentioning

confidence: 94%

Design of the SARS-CoV-2 RBD vaccine antigen improves neutralizing antibody response

et al. 2022

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“…According to the published results of phase 1 and phase 2a clinical trials, the Soberana 02 vaccine is safe and elicits an immune response in people aged 19–80 years and it induces neutralizing antibodies and a specific T-cell response [ 116 ]. The results of phase 3 clinical trials have shown the effectiveness of two doses of the Soberana 02 vaccine to be at 71.0%, while the addition of the Soberana Plus vaccine as a third dose (SARS-CoV-2 RBD dimer in combination with aluminum hydroxide) increases the effectiveness to 92.4% (IFV/COR/09) [ 117 ].…”

Section: Recombinant Covid-19 Vaccinesmentioning

confidence: 99%

Recombinant Protein Vaccines against Human Betacoronaviruses: Strategies, Approaches and Progress

Kovalenko

Ryabchevskaya

Evtushenko

et al. 2023

IJMS

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Betacoronaviruses have already troubled humanity more than once. In 2002–2003 and 2012, the SARS-CoV and MERS-CoV, respectively, caused outbreaks of respiratory syndromes with a fatal outcome. The spread of the SARS-CoV-2 coronavirus has become a pandemic. These three coronaviruses belong to the genus Betacoronavirus and have a zoonotic origin. The emergence of new coronavirus infections in the future cannot be ruled out, and vaccination is the main way to prevent the spread of the infection. Previous experience in the development of vaccines against SARS and MERS has helped to develop a number of vaccines against SARS-CoV-2 in a fairly short time. Among them, there are quite a few recombinant protein vaccines, which seem to be very promising in terms of safety, minimization of side effects, storage and transportation conditions. The problem of developing a universal betacoronavirus vaccine is also still relevant. Here, we summarize the information on the designing of vaccines based on recombinant proteins against highly pathogenic human betacoronaviruses SARS-CoV, MERS-CoV and SARS-CoV-2.

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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

Cited by 2 publications

References 20 publications

Design of the SARS-CoV-2 RBD vaccine antigen improves neutralizing antibody response

Design of the SARS-CoV-2 RBD vaccine antigen improves neutralizing antibody response

Recombinant Protein Vaccines against Human Betacoronaviruses: Strategies, Approaches and Progress

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