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Boletín Científico No. 18 (1-10 julio/2021) EN ESTE NÚMERO VacCiencia es una publicación dirigida a Resumen de candidatos vacu- investigadores y especialistas dedicados a nales contra la COVID-19 ba- la vacunología y temas afines, con el ob- sadas en la plataforma de sub- jetivo de serle útil. Usted puede realizar unidad proteica en desarrollo a sugerencias sobre los contenidos y de es- nivel mundial. (segunda parte) ta forma crear una retroalimentación Artículos científicos más que nos permita acercarnos más a sus recientes de Medline sobre necesidades de información. vacunas. Patentes más recientes en Patentscope sobre vacunas. Patentes más recientes en USPTO sobre vacunas. 1| Copyright © 2020. Todos los derechos reservados | INSTITUTO FINLAY DE VACUNAS Resumen de vacunas contra la COVID-19 basadas en la plataforma de subunidad proteica en desarrollo a nivel mundial (segunda parte) Las vacunas de subunidades antigénicas son aquellas en las que solamente se utilizan los fragmentos específicos (llamados «subunidades antigénicas») del virus o la bacteria que es indispensable que el sistema inmunitario reconozca. Las subunidades antigénicas suelen ser proteínas o hidratos de carbono. La mayoría de las vacunas que figuran en los calendarios de vacunación infantil son de este tipo y protegen a las personas de enfermedades como la tos ferina, el tétanos, la difteria y la meningitis meningocócica. Este tipo de vacunas solo incluye las partes del microorganismo que mejor estimulan al sistema inmunitario. En el caso de las desarrolladas contra la COVID-19 contienen generalmente, la proteína S o fragmentos de la misma como el Dominio de Unión al Receptor (RBD, por sus siglas en inglés). Una vez que el sistema inmunitario reconoce el antígeno, crea anticuerpos y glóbulos blancos de defensa. Si una persona se infecta con el virus SARS-CoV-2, los anticuerpos combatirán al virus. Vacunas reportadas en el draft landscape de la Organización Mundial de la Salud hasta el 9 de julio, basadas en la plataforma de subunidades proteicas (en el orden de aparición en el listado). _____________________________________________________________________________________ Nombre: EpiVacCorona Fabricante/País: Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"/Rusia Descripción: Es una vacuna basada en inmunógenos peptídicos de la proteína S del coronavirus del SARS- CoV-2 sintetizados químicamente y conjugados a la proteína N recombinante del SARS-CoV-2 (proteína transportadora) y adsorbidos en hidróxido de aluminio (adyuvante). Fase de ensayo clínico: 3 Vía de administración: Intramuscular. Esquema de administración: Dos dosis en un intervalo de 21 días. _____________________________________________________________________________________ Nombre: Insect Vaccine Fabricante/País: West China Hospital + Sichuan University/China Descripción: Vacuna recombinante basada en proteínas cultivadas a partir de células de insectos (baculovirus) expresadas en células Sf9. Fase de ensayo clínico: 3 Vía de administración: Intramuscular Esquema de inmunización: Dos dosis con intervalo de 28 días. _____________________________________________________________________________________ Nombre: IMP CoVac-1 Fabricante/País: University Hospital Tübingen/Alemania. Descripción: La vacuna comprende múltiples péptidos que consisten en varios epítopos virales. Los péptidos se administraron junto con Montanide™ ISA51 VG y un nuevo adyuvante lipopéptido, el ligando TLR2 / 1 XS15. Fase de ensayo clínico: 1 Vía de administración: Subcutánea. Esquema de inmunización: Una dosis. _____________________________________________________________________________________ Nombre: UB-612 Fabricante/País: United Biomedical Inc. Asia, Vaxxinity/Taiwán. Descripción: Es una vacuna basada en la proteína S1-RBD de diseño de alta precisión patentada que incorpora un conjunto de péptidos de epítopo Th / CTL que podría unirse a MHC-I y MHC-II humanos para activar las células T. Fase de ensayo clínico: 2/3. Vía de administración: Intramuscular. Esquema de inmunización: Dos dosis en un intervalo de 28 días. _____________________________________________________________________________________ Nombre: AdimrSC-2f Fabricante/País: Adimmune Corporation/Taiwán. Descripción: Es un candidato vacunal desarrollado usando el sistema de expresión de baculovirus-células de insecto, se amplifica y purifica el dominio de unión al receptor recombinante (RBD) de la proteína S del SARS-CoV-2. Está formulado en las diferentes dosis de proteína S con o sin contenido de aluminio como adyuvante. Fase de ensayo clínico: 1. Vía de administración: ND. Esquema de inmunización: ND. _____________________________________________________________________________________ Nombre: Mambisa (CIGB-669) Fabricante/País: Centro de Ingeniería Genética y Biotecnología (CIGB)/Cuba. Descripción: Se basa en la formulación de la proteína de RBD (Dominio de Unión al Receptor) y un inmunopotenciador evaluado por el centro: el antígeno de la nucleocápsida de la Hepatitis B. Fase de ensayo clínico: 1/2. Vía de administración: Intranasal. Esquema de inmunización: Tres dosis en un intervalo de 14 días o 28 días. _____________________________________________________________________________________ Nombre: Abdala (CIGB-66) Fabricante/País: Centro de Ingeniería Genética y Biotecnología (CIGB)/Cuba. Descripción: Vacuna que se basa en el dominio de la unión del receptor (RBD) de la proteína S del virus SARS-CoV-2, su segmento más protuberante. Se seleccionó la levadura Pichia pastoris como sistema de expresión. Al ser el RBD una glicoproteína asociada covalentemente, los sacáridos de Pichia pastoris le aportan un efecto inmunopotenciador que favorece la inmunogenicidad. Esta formulación está adyuvada en hidróxido de aluminio. Fase de ensayo clínico: 3. Vía de administración: Intramuscular. Esquema de inmunización: Tres dosis en un intervalo de 14 días. Eficacia: 92.28 %. _____________________________________________________________________________________ Nombre: CorbeVax Fabricante/País: Biological E. Limited/India. Descripción: Vacuna basada en el RBD, y como adyuvante Alhydrogel (Alum), en combinación con CpG1018. El RBD de la subunidad S1 se une al receptor de la enzima convertidora de angiotensina-2 (ACE2) en la membrana de la célula huésped y facilita la entrada del virus. La proteína RBD se expresa en la levadura Pichia pastoris. Fase de ensayo clínico: 1/2 Vía de administración: Intramuscular Esquema de inmunización: Dos dosis en un intervalo de 28 días. _____________________________________________________________________________________ Nombre: Nanocovax. Fabricante/País: Nanogen Pharmaceutical Biotechnology/Vietnam. Descripción: Vacuna desarrollada mediante el uso de la subunidad de proteína S recombinante que se une a nanopartículas de sílice, con adyuvante de aluminio. Fase de ensayo clínico: 3 Vía de administración: Intramuscular Esquema de inmunización: Dos dosis en un intervalo de 21 días. _____________________________________________________________________________________ Nombre: S-268019. Fabricante/País: Shionogi/Japón. Descripción: Vacuna desarrollada mediante el uso de la subunidad de proteína S recombinante que se une a nanopartículas de sílice, con adyuvante de aluminio. Fase de ensayo clínico: 1/2. Vía de administración: Intramuscular Esquema de inmunización: Dos dosis en un intervalo de 21 días. _____________________________________________________________________________________ Nombre: AKS-452 (SARS-CoV-2-RBD-Fc) Fabricante/País: University Medical Center Groningen + Akston Biosciences Inc./ Países Bajos, Estados Unidos. Descripción: Esta es una nueva proteína de fusión SARS-CoV-2-RBD-Fc diseñada biológicamente para inducir o potenciar una respuesta inmune mixta Th1 / Th2 en pacientes contra el RBD de la nueva proteína S de coronavirus. Fase de ensayo clínico: 1/2. Vía de administración: Subcutánea o Intramuscular Esquema de inmunización: Una dosis o dos dosis en un intervalo de 21 días. _____________________________________________________________________________________ Nombre: COVAC-1 y COVAC-2 Fabricante/País: University of Saskatchewan/Canadá. Descripción: En el caso de COVAC-2 contiene un segmento de proteína de pico SARS-CoV-2, llamada S1 y SWE como adyuvante que pertenece a una familia de adyuvantes a base de aceite. Fase de ensayo clínico: 1/2. Vía de administración: Intramuscular. Esquema de inmunización: Dos dosis en un intervalo de 28 días. _____________________________________________________________________________________ Nombre: GBP510 Fabricante/País: SK Bioscience Co., Ltd., CEPI/Corea del Sur, Noruega. Descripción: Vacuna de nanopartículas SARS-CoV-2 con AS03 (hidróxido de aluminio) como adyuvante. Fase de ensayo clínico: 1/2. Vía de administración: Intramuscular. Esquema de inmunización: Dos dosis en un intervalo de 28 días. _____________________________________________________________________________________ Nombre: Razi Cov Pars Fabricante/País: Razi Vaccine and Serum Research Institute/Irán. Descripción: La vacuna emplea versiones recombinantes de la proteína S y protege al sistema inmunológico contra el virus mediante la producción de anticuerpos. Fase de ensayo clínico: 2. Vía de administración: Intramuscular e Intranasal. Esquema de inmunización: Tres dosis, las dos primeras dosis por vía intramuscular y en un intervalo de 21 días y la tercera dosis por vía intranasal a los 51 días a partir de la primera dosis. _____________________________________________________________________________________
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