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- W2004694423 abstract "<h3>ABSTRACT</h3> <h3>Background</h3> SOBERANA 02 is a COVID-19 conjugate vaccine (recombinant RBD conjugated to tetanus toxoid). Phase 1 and 2 clinical trials demonstrated its high immunogenicity, promoting neutralizing IgG and specific T-cell response. A third dose, of SOBERANA Plus (RBD-dimer), further increased the specific anti-RBD neutralizing antibodies. <h3>Methods</h3> In a randomized, double-blind, placebo-controlled, phase-3 trial (https://rpcec.sld.cu/trials/RPCEC00000354-En) we randomly assigned 44 031 participants, aged 19–80 years to three groups to receive a) two doses, SOBERANA 02, or b) two doses, SOBERANA 02 and a third dose, SOBERANA Plus, or c) placebo. Study endpoints are vaccine efficacy (VE) evaluated through confirmed symptomatic COVID-19 and safety. During the trial, the SARS CoV-2 isolates in Havana were 74.0 % β, shifting gradually to 100% δ. <h3>Results</h3> Two doses of SOBERANA 02 protected against symptomatic COVID-19: 43 cases in the two-dose group (14 371) vs. 155 in the placebo group (14 403), VE 71.0%, adjusted (CI 95%, 58.9–79.1). The heterologous three-dose combination increased the protection: 15 cases in the vaccine groups (13 833) vs. 155 in the placebo group (14 303), VE 92.4%, adjusted (CI 95%, 86.9–95.6%). For the two-dose schedule, VE against severe COVID-19 was 63.0% and for death, 59.0%; for the heterologous three-dose schedule, VE was 100% in both cases. <h3>Conclusions</h3> This is the first phase-3 study of a three-dose, heterologous COVID-19 vaccine. Two doses of SOBERANA 02 were safe and attained efficacy of 71.0% in the adult population 19-80 y/o; incorporating SOBERANA Plus increased efficacy from 71.0 % to 92.4%." @default.
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- W2004694423 date "2003-12-01" @default.
- W2004694423 modified "2023-09-27" @default.
- W2004694423 title "Greenberg dysplasia (HEM) and lethal X linked dominant Conradi-Hunermann chondrodysplasia punctata (CDPX2): presentation of two cases with overlapping phenotype" @default.
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- W2004694423 doi "https://doi.org/10.1136/jmg.40.12.e129" @default.
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