Author: Guimaraes, Lays Cordeiro ; Rodrigues Alves, Marco Túllio ; Birbrair, Alexander ; Shepherd, Sarah ; da Silva, Natália Jordana Alves ; Marim, Fernanda Martins ; Braga, Ana Carolina Soares ; de Oliveira, Leonardo Camilo ; Ferreira, Heloísa Athaydes Seabra ; Teixeira, Mauro Martins ; Queiroz-Junior, Celso Martins ; Mitchell, Michael J ; Santos, Anderson Kenedy ; Scalzo Júnior, Sérgio Ricardo Aluotto ; da Silva, Walison Nunes ; Guimaraes, Pedro Pires Goulart ; Hamilton, Alex ; de Faria, Kevin Kelton Santos ; Fukumasu, Heidge ; Vasconcelos Costa, Vivian ; Costa, Pedro Augusto Carvalho ; de Aguiar, Renato Santana ; Teixeira-Carvalho, Andréa ; Figueiredo, Maria Marta ; Frezard, Frederic

AbstractA safe and effective vaccine with long-term protection against SARS-CoV-2 variants of concern (VOCs) is a global health priority. Here, we develop lipid nanoparticles (LNPs) to provide safe and effective delivery of plasmid DNA (pDNA) and show protection against VOCs in female small animal models. Using a library of LNPs encapsulating unique barcoded DNA (b-DNA), we screen for b-DNA delivery after intramuscular administration. The top-performing LNPs are further tested for their capacity of pDNA uptake in antigen-presenting cells in vitro. The lead LNP is used to encapsulate pDNA encoding the HexaPro version of SARS-CoV-2 spike (LNP-HPS) and immunogenicity and protection is tested in vivo. LNP-HPS elicit a robust protective effect against SARS-CoV-2 Gamma (P.1), correlating with reduced lethality, decreased viral load in the lungs and reduced lung damage. LNP-HPS induce potent humoral and T cell responses against P.1, and generate high levels of neutralizing antibodies against P.1 and Omicron (B.1.1.529). Our findings indicate that the protective efficacy and immunogenicity elicited by LNP-HPS are comparable to those achieved by the approved COVID-19 vaccine from Biontech/Pfizer in animal models. Together, these findings suggest that LNP-HPS hold great promise as a vaccine candidate against VOCs.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Preclinical	Brazil	Universidade Federal de Minas Gerais	18 Jan 2024

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