■我们的目的是评估疗效,安全,和SARS-CoV-2mRNA疫苗(OmicronBA.5)LVRNA012的免疫原性在中国已免疫但无SARS-CoV-2感染的成年人中作为加强剂。
■这是一个单中心,随机化,双盲,安慰剂对照的3期临床试验招募健康的成年参与者(≥18岁),这些参与者至少在6个月前完成了两剂或三剂灭活的COVID-19疫苗,在蚌埠,安徽省,中国。符合条件的参与者被随机分配(1:1)接受LVRNA012疫苗(100ug)或安慰剂的加强肌内疫苗接种。主要终点是疫苗接种后14天,加强剂量的LVRNA012疫苗或安慰剂对任何严重程度的症状性COVID-19的保护功效。干预后14天至180天,实验室确认的COVID-19感染被确定,在干预后7至90天之间,每月8次积极监测有症状的疾病,在90至180天之间每月至少一次。
■招募了2615名参与者,并以1:1的比例随机分配到疫苗组(1308)或安慰剂组(1307)。在加强免疫后14天,共有141人(LVRNA012组46人,安慰剂组95人)出现有症状的COVID-19感染,显示疫苗效力为51.9%(95%CI,31.3%至66.4%)。在XBB在社区流行期间,大多数感染是在干预后90天检测到的。在LVRNA012疫苗接种后,64%的参与者报告了不良反应,但大多数是轻度或中度的。与安慰剂组(GMT12.5[8.4,18.7])相比,在第14天,用LVRNA012mRNA疫苗的加强疫苗接种可显著增强针对Omicron变体XBB.1.5(GMT132.3[99.8,175.4])的中和抗体滴度(先前免疫的个体)。
■LVRNA012mRNA疫苗具有免疫原性,在omicron占主导地位的时期,在预防COVID-19方面表现出强劲的疗效。
■ClinicalTrials.gov,标识符NCT05745545。
UNASSIGNED: We aimed to evaluate the efficacy, safety, and immunogenicity of a SARS-CoV-2 mRNA vaccine (Omicron BA.5) LVRNA012 given as the booster in immunized but SARS-CoV-2 infection-free adults in China.
UNASSIGNED: This is a single-center, randomized, double-blind, placebo-controlled phase 3 clinical trial enrolling healthy adult participants (≥18 years) who had completed two or three doses of inactivated COVID-19 vaccines at least 6 months before, in Bengbu, Anhui province, China. Eligible participants were randomly assigned (1:1) to receive a booster intramuscular vaccination with an LVRNA012 vaccine (100ug) or placebo. The primary endpoint was the protective efficacy of a booster dose of the LVRNA012 vaccine or placebo against symptomatic COVID-19 of any severity 14 days after vaccination. Laboratory-confirmed COVID-19 infections were identified from 14 days to 180 days after intervention, with active surveillance for symptomatic illness 8 times per month between 7 to 90 days and at least once per month between 90 to 180 days after intervention.
UNASSIGNED: 2615 participants were recruited and randomly assigned in a 1:1 ratio to either the vaccine group (1308) or the placebo group (1307). A total of 141 individuals (46 in the LVRNA012 group and 95 in the placebo group) developed symptomatic COVID-19 infection 14 days after the booster immunization, showing a vaccine efficacy of 51.9% (95% CI, 31.3% to 66.4%). Most infections were detected 90 days after intervention during a period when XBB was prevalent in the community. Adverse reactions were reported by 64% of participants after the LVRNA012 vaccination, but most of them were mild or moderate. The booster vaccination with the LVRNA012 mRNA vaccine could significantly enhance neutralizing antibody titers against the Omicron variant XBB.1.5 (GMT 132.3 [99.8, 175.4]) than did those in the placebo group (GMT 12.5 [8.4, 18.7]) at day 14 for the previously immunized individuals.
UNASSIGNED: The LVRNA012 mRNA vaccine is immunogenic, and shows robust efficacy in preventing COVID-19 during the omicron-predominate period.
UNASSIGNED: ClinicalTrials.gov, identifier NCT05745545.