RESUMO
Evolution of SARS-CoV-2 variants emphasizes the need for multivalent vaccines capable of simultaneously targeting multiple strains. SCTV01E is a tetravalent COVID-19 vaccine derived from the spike protein of SARS-CoV-2 variants Alpha, Beta, Delta, and Omicron BA.1. In this double-blinded placebo-controlled pivotal efficacy trial (NCT05308576), the primary endpoint was vaccine efficacy (VE) against COVID-19 seven days post-vaccination in individuals without recent infection. Other endpoints included evaluating safety, immunogenicity, and the VE against all SARS-CoV-2 infections in individuals meeting the study criteria. Between December 26, 2022, and January 15, 2023, 9,223 individuals were randomized at a 1:1 ratio to receive SCTV01E or a placebo. SCTV01E showed a VE of 69.4% (95% CI: 50.6, 81.0) 7 days post-vaccination, with 75 cases in the placebo group and 23 in the SCTV01E group for the primary endpoint. VEs were 79.7% (95% CI: 51.0, 91.6) and 82.4% (95% CI: 57.9, 92.6), respectively, for preventing symptomatic infection and all SARS-CoV-2 infections 14 days post-vaccination. SCTV01E elicited a 25.0-fold higher neutralizing antibody response against Omicron BA.5 28 days post-vaccination compared to placebo. Reactogenicity was generally mild and transient, with no reported vaccine-related SAE, adverse events of special interest (AESI), or deaths. The trial aligned with the shift from dominant variants BA.5 and BF.7 to XBB, suggesting SCTV01E as a potential vaccine alternative effective against present and future variants.
Assuntos
Anticorpos Antivirais , Vacinas contra COVID-19 , COVID-19 , SARS-CoV-2 , Eficácia de Vacinas , Humanos , Vacinas contra COVID-19/imunologia , Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Método Duplo-Cego , Feminino , Masculino , COVID-19/prevenção & controle , COVID-19/imunologia , COVID-19/virologia , SARS-CoV-2/imunologia , Adulto , Pessoa de Meia-Idade , Anticorpos Antivirais/imunologia , Glicoproteína da Espícula de Coronavírus/imunologia , Anticorpos Neutralizantes/imunologia , Idoso , Adulto Jovem , Imunogenicidade da Vacina , Adolescente , Vacinação/métodosRESUMO
The title mononuclear Zn(II) complex, [ZnCl(2)(C(15)H(13)N(5))(2)], is isotypic with the previously reported Hg(II) complex. The Zn(II) atom is located on a twofold rotation axis and has a distorted tetra-hedral environment of two Cl atoms and two N atoms from two heterocyclic ligands. In the crystal, complex mol-ecules are extended by inter-molecular π-π inter-actions [centroid-centroid distance = 3.792â (2)â Å] into a three-dimensional supra-molecular network.