<?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>0253-570X</journal-id>
<journal-title><![CDATA[Revista de Salud Animal]]></journal-title>
<abbrev-journal-title><![CDATA[Rev Salud Anim.]]></abbrev-journal-title>
<issn>0253-570X</issn>
<publisher>
<publisher-name><![CDATA[Centro Nacional de Sanidad Agropecuaria]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0253-570X2023000100003</article-id>
<title-group>
<article-title xml:lang="en"><![CDATA[Safety and immunogenicity in piglets of the vaccine candidate E2-CD154, a subunit vaccine against classical swine fever. Results from phase III clinical trial]]></article-title>
<article-title xml:lang="es"><![CDATA[Seguridad e inmunogenicidad en lechones con el candidato vacunal E2-CD154, una vacuna de subunidades contra la peste porcina clásica. Resultados del ensayo clínico de fase III]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pérez-Pérez]]></surname>
<given-names><![CDATA[Danny]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sordo-Puga]]></surname>
<given-names><![CDATA[Yusmel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodríguez-Moltó]]></surname>
<given-names><![CDATA[María Pilar]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sosa-Testé]]></surname>
<given-names><![CDATA[Iliana]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[León-Goñi]]></surname>
<given-names><![CDATA[Avelina]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Sardina]]></surname>
<given-names><![CDATA[Talía]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Méndez]]></surname>
<given-names><![CDATA[Mary Karla]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Fuentes-Rodríguez]]></surname>
<given-names><![CDATA[Yohandy]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Montero-Espinosa]]></surname>
<given-names><![CDATA[Carlos A.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Duarte]]></surname>
<given-names><![CDATA[Carlos A.]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Suárez-Pedroso]]></surname>
<given-names><![CDATA[Marisela]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro de Ingeniería Genética y Biotecnología Departamento de Biotecnología Animal ]]></institution>
<addr-line><![CDATA[Playa La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Centro para la Producción de Animales de Laboratorio Centro de Toxicología Experimental ]]></institution>
<addr-line><![CDATA[ Mayabeque]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>00</month>
<year>2023</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>00</month>
<year>2023</year>
</pub-date>
<volume>45</volume>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S0253-570X2023000100003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S0253-570X2023000100003&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S0253-570X2023000100003&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT E2-CD154 is a subunit vaccine candidate that has been proven to be safe and to protect piglets from classical swine fever (CSF). In this study, those previous findings were confirmed and extended to a larger number of animals in a phase III clinical trial conducted on two production farms in Pinar del Río province. All animals in both farms were vaccinated with two doses of E2-CD154 on days 0 and 21. The study extended up to 60 weeks. The vaccine was well tolerated in piglets between 15 and 28 days of life, with neither local nor systemic side effects documented. Immunized pregnant sows were capable of transmitting high levels of maternally-derived neutralizing antibodies (MDNAs) to their offspring (Unit A, geometric mean titer = 1:1295, minimum value 1:100 and Unit B geometric mean titer = 1:474, minimum value 1:150), well above the protection threshold (1:50). These high MDNA titers in the piglets did not interfere with the immunogenicity of the candidate. All vaccinated piglets evaluated at random (more than 10% of 2804 vaccinated) developed protective neutralizing antibody titers higher than 1:400 at the four time points analyzed (nine, 21, 41, and 44 weeks) in both farms. The results of this study confirm the safety, immunogenicity and robustness of this vaccine candidate in this sensitive pig category in the field.]]></p></abstract>
<abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN El candidato vacunal E2-CD154 es una vacuna de subunidad cuya seguridad y capacidad protectora en crías frente a la peste porcina clásica ha sido demostrada en estudios previos. Esos hallazgos se confirman en el presente estudio de fase III realizado en dos unidades de producción porcina en la provincia de Pinar del Rio con un número mayor de animales. Todos los animales en ambas granjas recibieron dos dosis de E2-CD154 los días 0 y 21. El estudio se extendió por 60 semanas, la vacuna fue bien tolerada en las crías vacunadas entre los 15 y 28 días de edad, no se documentaron efectos adversos locales o sistémicos. Las cerdas gestantes inmunizadas fueron capaces de trasmitir altos títulos de anticuerpos a sus crías (Unidad A, media geométrica = 1:1295, valor mínimo 1:100 y Unidad B, media geométrica = 1:474, valor mínimo 1:150), muy por encima del umbral de protección (1:50). Estos elevados títulos de anticuerpos neutralizantes derivados de la madre no interfirieron con la inmunogenicidad del candidato vacunal en estudio. Todas las crías vacunadas estudiadas al azar (más del 10% de las 2804) desarrollaron títulos de anticuerpos neutralizantes mayores de 1:400 en los cuatro muestreos realizados (nueve, 21, 41, y 44 semanas) en ambas granjas. Los resultados de este estudio confirman la seguridad, inmunogenicidad y robustez del candidato vacunal en esta sensible categoría en condiciones de campo.]]></p></abstract>
<kwd-group>
<kwd lng="en"><![CDATA[Subunit vaccine]]></kwd>
<kwd lng="en"><![CDATA[classical swine fever]]></kwd>
<kwd lng="en"><![CDATA[maternally-derived neutralizing antibodies (MDNAs)]]></kwd>
<kwd lng="en"><![CDATA[production farm]]></kwd>
<kwd lng="en"><![CDATA[neutralizing antibodies]]></kwd>
<kwd lng="en"><![CDATA[phase III clinical trial]]></kwd>
<kwd lng="es"><![CDATA[Vacuna de subunidad]]></kwd>
<kwd lng="es"><![CDATA[peste porcina clásica]]></kwd>
<kwd lng="es"><![CDATA[anticuerpos neutralizantes derivados de la madre]]></kwd>
<kwd lng="es"><![CDATA[unidad de producción]]></kwd>
<kwd lng="es"><![CDATA[anticuerpos neutralizantes]]></kwd>
<kwd lng="es"><![CDATA[estudio clínico fase III]]></kwd>
</kwd-group>
</article-meta>
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