<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>2304-0106</journal-id>
<journal-title><![CDATA[Anales de la Academia de Ciencias de Cuba]]></journal-title>
<abbrev-journal-title><![CDATA[Anales de la ACC]]></abbrev-journal-title>
<issn>2304-0106</issn>
<publisher>
<publisher-name><![CDATA[Academia de Ciencias de Cuba]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2304-01062023000100020</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Diseño, desarrollo y evaluación preclínica de SOBERANA®02: una vacuna cubana contra COVID-19]]></article-title>
<article-title xml:lang="en"><![CDATA[Design, development and preclinical evaluation of SOBERANA02: A Cuban vaccine against COVID-19]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Valdés Balbín]]></surname>
<given-names><![CDATA[Yury]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Santana Mederos]]></surname>
<given-names><![CDATA[Darielys]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Quintero Moreno]]></surname>
<given-names><![CDATA[Lauren María]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fernández Castillo]]></surname>
<given-names><![CDATA[Sonsire]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodríguez Noda]]></surname>
<given-names><![CDATA[Laura Marta]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sánchez Ramírez]]></surname>
<given-names><![CDATA[Belinda]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pérez Nicado]]></surname>
<given-names><![CDATA[Rocmira]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Acosta Grogues]]></surname>
<given-names><![CDATA[Claudia Ofelia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Méndez Gómez]]></surname>
<given-names><![CDATA[Yanira]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[García Ricardo]]></surname>
<given-names><![CDATA[Manuel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández García]]></surname>
<given-names><![CDATA[Tays]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Bergado Báez]]></surname>
<given-names><![CDATA[Gretchen]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pi Estopiñán]]></surname>
<given-names><![CDATA[Franciscary]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Valdés Zayas]]></surname>
<given-names><![CDATA[Anet]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Carmenate Portilla]]></surname>
<given-names><![CDATA[Tania]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ramírez González]]></surname>
<given-names><![CDATA[Ubel Jesús]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Oliva Hernández]]></surname>
<given-names><![CDATA[Reynaldo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Soubal Mora]]></surname>
<given-names><![CDATA[Jean Pierre]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Garrido Arteaga]]></surname>
<given-names><![CDATA[Raine]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cardoso San Jorge]]></surname>
<given-names><![CDATA[Felix]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Chovel Cuervo]]></surname>
<given-names><![CDATA[Mario Landys]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[González Rodríguez]]></surname>
<given-names><![CDATA[Humberto]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fariñas Medina]]></surname>
<given-names><![CDATA[Mildrey]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Hernández Salazar]]></surname>
<given-names><![CDATA[Tamara]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Enríquez Puertas]]></surname>
<given-names><![CDATA[Juliet M.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Noa Romero]]></surname>
<given-names><![CDATA[Enrique]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Suárez Batista]]></surname>
<given-names><![CDATA[Anamary]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Espinosa Rodríguez]]></surname>
<given-names><![CDATA[Luis Ariel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ramos Gómez]]></surname>
<given-names><![CDATA[Yassel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[González López]]></surname>
<given-names><![CDATA[Luis Javier]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Climent Ruiz]]></surname>
<given-names><![CDATA[Yanet]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rojas Dorantes]]></surname>
<given-names><![CDATA[Gertrudis]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Relova Hernández]]></surname>
<given-names><![CDATA[Ernesto]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cabrera Infante]]></surname>
<given-names><![CDATA[Yanelys]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Lozada Chang]]></surname>
<given-names><![CDATA[Sum Lai]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Boggiano Ayo]]></surname>
<given-names><![CDATA[Tammy]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ojito Magaz]]></surname>
<given-names><![CDATA[Eduardo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[León Monzón]]></surname>
<given-names><![CDATA[Kalet]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
<xref ref-type="aff" rid="A0"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Chiodo]]></surname>
<given-names><![CDATA[Fabrizio]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Paquet]]></surname>
<given-names><![CDATA[Françoise]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Castellanos Serra]]></surname>
<given-names><![CDATA[Lila Rosa]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
<xref ref-type="aff" rid="Aaf"/>
<xref ref-type="aff" rid="A0"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[García Rivera]]></surname>
<given-names><![CDATA[Daniel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[García Rivera]]></surname>
<given-names><![CDATA[Dagmar]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Verez Bencomo]]></surname>
<given-names><![CDATA[Vicente Guillermo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Instituto Finlay de Vacunas  ]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Centro de Inmunología Molecular  ]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Laboratorio de Síntesis Química y Biomolecular Facultad de Química Universidad de La Habana]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af4">
<institution><![CDATA[,Centro de Investigaciones de la Defensa Civil  ]]></institution>
<addr-line><![CDATA[ Mayabeque]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af5">
<institution><![CDATA[,Centro de Promoción Fenglin Glycodrug  ]]></institution>
<addr-line><![CDATA[ Shanghai]]></addr-line>
<country>Republica de China</country>
</aff>
<aff id="Af6">
<institution><![CDATA[,Centro de Ingeniería Genética y Biotecnología  ]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af7">
<institution><![CDATA[,Instituto de Química Biomolecular Departmento de Biología Molecular e Immunología ]]></institution>
<addr-line><![CDATA[ Napoles]]></addr-line>
<country>Italia</country>
</aff>
<aff id="Af8">
<institution><![CDATA[,Centro de Biofísica Molécular  ]]></institution>
<addr-line><![CDATA[ Orléans]]></addr-line>
<country>Francia</country>
</aff>
<aff id="Af9">
<institution><![CDATA[,Chengdu Olisynn Biotech Laboratorio del Centro de Terapia Biológica y Cáncer Hospital Oeste de China, Sichuan Universidad]]></institution>
<addr-line><![CDATA[ Chengdu]]></addr-line>
<country>República Popular de China</country>
</aff>
<aff id="A10">
<institution><![CDATA[,Academia de Ciencias de Cuba  ]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>04</month>
<year>2023</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>04</month>
<year>2023</year>
</pub-date>
<volume>13</volume>
<numero>1</numero>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S2304-01062023000100020&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S2304-01062023000100020&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S2304-01062023000100020&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Introducción:  El control de la pandemia global de COVID-19 depende, entre otras medidas, del desarrollo de vacunas preventivas contra el SARS-CoV-2. La infección del virus está mediada por la interacción del trímero de la glicoproteína espiga, a través de su dominio de unión al receptor (RBD), con el receptor celular del hospedero. Las vacunas en uso o en desarrollo buscan generar anticuerpos neutralizantes para bloquear la interacción del virus con el receptor ACE2. La respuesta de anticuerpos hacia este dominio correlaciona bien con la neutralización viral.  Métodos:  El desarrollo y la evaluación preclínica de SOBERANA02 se realizó en 4 etapas fundamentales: diseño del inmunógeno; obtención del antígeno viral RBD mediante técnica recombinante; obtención y caracterización de conjugados RBDn-TT y evaluación de la inmunogenicidad de los conjugados en animales de laboratorios.  Resultados y discusión:  Este trabajo muestra que una construcción macromolecular compuesta de RBD recombinante conjugado a toxoide tetánico (TT) induce una respuesta inmune potente en animales de laboratorios. Algunas ventajas de la inmunización con el conjugado RBD-TT son la respuesta predominante de IgG contra el RBD debido a la maduración de la afinidad y una respuesta en memoria de células B específicas. Conclusiones, Este resultado demostró el potencial de este candidato vacunal contra COVID-19 y permitió su avance a ensayos clínicos, abriendo el camino para otras vacunas conjugadas antivirales.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Introduction:  Controlling the global COVID-19 pandemic depends, among other measures, on developing preventive vaccines against SARS-CoV-2. Virus infection is mediated by the interaction of the spike glycoprotein trimer, via its receptor binding domain (RBD), with the host&#8217;s cellular receptor. Vaccines in use or under development seek to elicit neutralizing antibodies to block virus binding to ACE2 receptor. Antibody response to this domain is an important outcome of immunization and correlates well with viral neutralization.  Methods:  The development and preclinical evaluation of SOBERANA02 was carried out in four fundamental stages: immunogen design; obtaining the RBD viral antigen by recombinant technique; obtaining and characterizing RBDn-TT conjugates, and evaluation of conjugates immunogenicity in laboratory animals.  Results and discussion:  Here we show that macromolecular constructs with recombinant RBD conjugated to tetanus toxoid (TT) induce a potent immune response in laboratory animals. Some advantages of immunization with RBD-TT conjugates include a predominant anti-RBD IgG immune response due to affinity maturation and long-term specific B-memory cells. Conclusions, this result demonstrated the potential of this COVID-19 conjugate vaccine candidate and enabled its advance to clinical evaluation, paving the way for other antiviral conjugate vaccines.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Infección por SARS-CoV-2]]></kwd>
<kwd lng="es"><![CDATA[vacunas contra la COVID-19]]></kwd>
<kwd lng="es"><![CDATA[inmunidad]]></kwd>
<kwd lng="es"><![CDATA[vacunas conjugadas]]></kwd>
<kwd lng="en"><![CDATA[SARS-CoV-2 Infection]]></kwd>
<kwd lng="en"><![CDATA[COVID-19 vaccines]]></kwd>
<kwd lng="en"><![CDATA[immunity]]></kwd>
<kwd lng="en"><![CDATA[vaccines, conjugate]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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