RESUMEN
This was a phase 1 dose-escalation study of ZR202-CoV, a recombinant protein vaccine candidate containing a pre-fusion format of the spike (S)-protein (S-trimer) combined with the dual-adjuvant system of Alum/CpG. A total of 230 participants were screened and 72 healthy adults aged 18-59 years were enrolled and randomized to receive two doses at a 28-day interval of three different ZR202-CoV formulations or normal saline. We assessed the safety for 28 days after each vaccination and collected blood samples for immunogenicity evaluation. All formulations of ZR202-CoV were well-tolerated, with no observed solicited adverse events ≥ Grade 3 within 7 days after vaccination. No unsolicited adverse events ≥ Grade 3, or serious adverse events related to vaccination occurred as determined by the investigator. After the first dose, detectable immune responses were observed in all subjects. All subjects that received ZR202-CoV seroconverted at 14 days after the second dose by S-binding IgG antibody, pseudovirus and live-virus based neutralizing antibody assays. S-binding response (GMCs: 2708.7 ~ 4050.0 BAU/mL) and neutralizing activity by pseudovirus (GMCs: 363.1 ~ 627.0 IU/mL) and live virus SARS-CoV-2 (GMT: 101.7 ~ 175.0) peaked at 14 days after the second dose of ZR202-CoV. The magnitudes of immune responses compared favorably with COVID-19 vaccines with reported protective efficacy.
Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Adulto , Humanos , Adyuvantes Inmunológicos , Anticuerpos Neutralizantes , Anticuerpos Antivirales , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Método Doble Ciego , Inmunogenicidad Vacunal , SARS-CoV-2 , Vacunas Sintéticas/efectos adversos , Vacunas Sintéticas/genética , Adolescente , Adulto Joven , Persona de Mediana EdadRESUMEN
The pollution characteristics of polycyclic aromatic hydrocarbons (PAHs), organochlorine pesticides (OCPs), and phthalate esters (PAEs) in the surface sediments of Xiaoxingkai Lake were analyzed by GC-MS, and the main sources and biological toxicity risks of the pollutants were discussed. The results show that:â The content of PAHs in the sediments of xiaoxingkai lake ranged from 82.1 to 534.6 ng·g-1, and the concentration of PAHs in the northwestern port of the lake was higher. The content of OCPs and PAEs in the sediments ranged from 4.8 to 50.4 ng·g-1 and 33.3 to 401.6 ng·g-1, respectively. The concentration was higher in the southeastern lakes. â¡ PAHs in the sediments were dominated by 3-5-ring compounds (accounting for more than 85%), which were mainly combustion sources, among which the combustion of coal and firewood contributed 47%, the combustion of gasoline and diesel contributed 39%, and the oil product leakage contributed 14%. The OCPs were mainly HCHs (78%) from the use of new lindane and the input of a small amount of industrial HCHs. The PAEs were mainly dibutyl phthalate (DBP) and diethyl phthalate (2-ethyl hexyl) ester (DEHP; 94%), which were mainly derived from household garbage and common human articles. ⢠Compared with other lakes in China, PAHs and PAEs in the sediments of Xiaoxingkai Lake are at a low pollution level, and there is no ecological risk at present, but some OCPs at some points present a moderate ecological risk.