{"id":237402,"date":"2021-04-12T11:29:36","date_gmt":"2021-04-12T15:29:36","guid":{"rendered":"https:\/\/oncubanews.com\/en\/?p=237402"},"modified":"2021-04-12T11:29:36","modified_gmt":"2021-04-12T15:29:36","slug":"cuba-second-phase-of-trials-with-soberana-plus-in-convalescent-covid-19-patients-approved","status":"publish","type":"post","link":"https:\/\/oncubanews.com\/en\/coronavirus\/cuba-second-phase-of-trials-with-soberana-plus-in-convalescent-covid-19-patients-approved\/","title":{"rendered":"Cuba: Second phase of trials with Soberana Plus in convalescent COVID-19 patients approved"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">The Cuban Center for State Control of Medicines, Equipment and Medical Devices (CECMED) approved this Friday the Phase II clinical trial of a dose of the Soberana Plus <\/span><a href=\"https:\/\/oncubanews.com\/en\/tag\/cuban-vaccine-against-covid-19\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">vaccine candidate<\/span><\/a><span style=\"font-weight: 400;\"> in convalescent <\/span><a href=\"https:\/\/oncubanews.com\/en\/coronavirus\/\"><span style=\"font-weight: 400;\">COVID-19<\/span><\/a><span style=\"font-weight: 400;\"> patients.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The study, which will be developed at the Institute of Hematology and Immunology and at the National Center for Sex Education, aims to evaluate the safety, reactogenicity and immunogenicity of the Cuban drug, <\/span><a href=\"http:\/\/www.cubadebate.cu\/noticias\/2021\/04\/09\/aprueba-cecmed-inicio-del-ensayo-clinico-fase-ii-de-soberana-plus-en-convalecientes-de-covid-19\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Cubadebate<\/span><\/a><span style=\"font-weight: 400;\"> reported.<\/span><\/p>\n<blockquote class=\"twitter-tweet\" data-width=\"500\" data-dnt=\"true\">\n<p lang=\"es\" dir=\"ltr\">Aprueba el CECMED el inicio del Ensayo Cl\u00ednico Fase II del candidato vacunal SOBERANA Plus,  en convalecientes de COVID-19. <a href=\"https:\/\/t.co\/qLKycDjsTj\">https:\/\/t.co\/qLKycDjsTj<\/a><\/p>\n<p>&mdash; CECMED (@cubacecmed) <a href=\"https:\/\/twitter.com\/cubacecmed\/status\/1380684234063544323?ref_src=twsrc%5Etfw\">April 10, 2021<\/a><\/p><\/blockquote>\n<p><script async src=\"https:\/\/platform.twitter.com\/widgets.js\" charset=\"utf-8\"><\/script><\/p>\n<p><span style=\"font-weight: 400;\">Soberana Plus is the world\u2019s first vaccine candidate designed for recovered COVID-19 patients to reach clinical trials, the source said.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">According to the Cuban regulatory authority, the trial will involve volunteer \u201cconvalescent adults of both sexes, aged between 19-80, with a history of mild or moderate COVID-19, or asymptomatic infection.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A <\/span><a href=\"https:\/\/www.cecmed.cu\/noticias\/aprueba-cecmed-inicio-ensayo-clinico-fase-ii-candidato-vacunal-soberana-plus\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">note<\/span><\/a><span style=\"font-weight: 400;\"> from CECMED adds that the approval of the study is based on the results obtained in the previous phase of clinical trials with the vaccine candidate, which demonstrated the ability to \u201cinduce high titers of neutralizing antibodies in convalescents.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">For her part, the director of research at the Finlay Vaccine Institute (IFV), Dagmar Garc\u00eda, stated that the formula has shown \u201cexcellent safety and immunogenicity results with a single dose in Phase I, which position this strategy.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Developed by IFV scientists, the drug was included as a third dose\u2014also called a booster dose\u2014in vaccination schemes of the three phases of clinical trials with Soberana 02, and in Phase I with Soberana 01.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Cited by the source, Garc\u00eda affirmed that this is a new step in the search for a vaccine for convalescents from the contagious disease, \u201ctoday more necessary in the scenario of mutants.\u201d<\/span><\/p>\n<blockquote class=\"wp-embedded-content\" data-secret=\"gYI8cCcxNf\"><p><a href=\"https:\/\/oncubanews.com\/en\/coronavirus\/cuba-prepared-for-more-dangerous-coronavirus-mutation\/\">Cuba prepared for more dangerous coronavirus mutation<\/a><\/p><\/blockquote>\n<p><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; clip: rect(1px, 1px, 1px, 1px);\" title=\"&#8220;Cuba prepared for more dangerous coronavirus mutation&#8221; &#8212; OnCubaNews English\" src=\"https:\/\/oncubanews.com\/en\/coronavirus\/cuba-prepared-for-more-dangerous-coronavirus-mutation\/embed\/#?secret=CWhUTRUTeE#?secret=gYI8cCcxNf\" data-secret=\"gYI8cCcxNf\" width=\"500\" height=\"282\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe><\/p>\n<p><span style=\"font-weight: 400;\">Cuba is prepared for the most dangerous mutation of the coronavirus registered in some of its variants, the president of the Cuban Biotechnology and Pharmaceutical Industries (BioCubaFarma) conglomerate, Eduardo Mart\u00ednez, said this Thursday.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u201cWe have the genes that codify for the Receptor Binding Domain (RBD) variant of this mutation,\u201d the most worrying because it decreases the neutralizing capacity of antibodies, both in convalescents and in vaccinated people, Mart\u00ednez said during the Mesa Redonda television program<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The study, which will be developed at the Institute of Hematology and Immunology and at the National Center for Sex Education, aims to evaluate the safety, reactogenicity and immunogenicity of the Cuban drug.<\/p>\n","protected":false},"author":3134,"featured_media":237405,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[33393,13916],"tags":[15273,33386],"ppma_author":[33546],"class_list":["post-237402","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-coronavirus","category-science-in-cuba","tag-cuban-science","tag-cuban-vaccine-against-covid-19"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cuba: Second phase of trials with Soberana Plus in convalescent COVID-19 patients approved | OnCubaNews English<\/title>\n<meta name=\"description\" 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