RESUMO
A Gamma Variant RBD-based aluminum hydroxide adjuvanted vaccine called ARVAC CG was selected for a first in human clinical trial. Healthy male and female participants (18-55 years old) with a complete COVID-19-primary vaccine scheme were assigned to receive two intramuscular doses of either a low-dose or a high-dose of ARVAC CG. The primary endpoint was safety. The secondary objective was humoral immunogenicity. Cellular immune responses were studied as an exploratory objective. The trial was prospectively registered in PRIISA.BA (Registration Code 6564) and ANMAT and retrospectively registered in ClinicalTrials.gov (NCT05656508). Samples from participants of a surveillance strategy implemented by the Ministry of Health of the Province of Buenos Aires that were boosted with BNT162b2 were also analyzed to compare with the booster effect of ARVAC CG. ARVAC CG exhibits a satisfactory safety profile, a robust and broad booster response of neutralizing antibodies against the Ancestral strain of SARS-CoV-2 and the Gamma, Delta, Omicron BA.1 and Omicron BA.5 variants of concern and a booster effect on T cell immunity in individuals previously immunized with different COVID-19 vaccine platforms.
Assuntos
COVID-19 , Vacinas , Adolescente , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Adjuvantes Imunológicos , Anticorpos Neutralizantes , Anticorpos Antivirais , Vacina BNT162 , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , SARS-CoV-2RESUMO
El aumento de la prevalencia de Pseudomonas aeruginosa multirresistente ocasiona un desafío terapéutico constante en las Unidades de Cuidados Intensivos en general y de Quemados en particular. El presente trabajo epidemiológico reveló una tasa de infecciones hospitalarias de 18,91/1000 pacientes/día, con un total de 63 episodios. La tasa de bacteriemia asociada a vía venosa central (VVC) fue de 13,48/1000 días de uso de VVC, con una taza de utilización del 80,6% y 19 episodios de bacteriemia. Los gérmenes mas frecuentemente hallados en las infecciones hospitalarias fueron Pseudomonas aeruginosa, Fusarium spp y Acinetobacter spp (37,5%, 8,3% y 6,9%, respectivamente). Pseudomona aeruginosa estuvo presente como microorganismo causal de infección hospitalaria en 27 casos, siendo multirresistente en todos y con sensibilidad exclusiva al colistin.