背景:我们评估了SCB-2019的安全性,SCB-2019是一种包含重组SARS-CoV-2刺突(S)三聚体融合蛋白的蛋白质亚单位疫苗候选物,结合CpG-1018/明矾佐剂。
方法:这个正在进行的2/3阶段,双盲,安慰剂对照,比利时正在进行随机试验,巴西,哥伦比亚,菲律宾,和南非≥12岁的参与者。参与者被随机分配接受2剂SCB-2019或安慰剂,间隔21天肌肉注射。这里,我们介绍了SCB-2019在所有成年参与者(≥18岁)进行2剂初次疫苗接种后6个月期间的安全性结果.
结果:在2021年3月24日至2021年12月1日期间,共有30,137名成年参与者接受了至少一剂研究疫苗(n=15,070)或安慰剂(n=15,067)。未经请求的不良事件,医疗护理不良事件,特别关注的不良事件,在6个月随访期间,两个研究组的严重不良事件报告频率相似.15,070名SCB-2019接受者中有4人报告了疫苗相关的SAE(两名参与者的超敏反应,贝尔麻痹,和自然流产)和15,067名安慰剂接受者中的2名(COVID-19,肺炎,一名参与者出现急性呼吸窘迫综合征,另一名参与者出现自然流产)。没有观察到疫苗相关增强疾病的迹象。
结论:SCB-2019作为2剂量系列给药具有可接受的安全性。在初次接种疫苗后的6个月随访期间未发现安全性问题。
背景:NCT04672395;EudraCT:2020-004272-17。
We evaluated the safety of SCB-2019, a protein subunit vaccine candidate containing a
recombinant SARS-CoV-2 spike (S) trimer fusion protein, combined with CpG-1018/alum adjuvants.
This ongoing phase 2/3, double-blind, placebo-controlled, randomized
trial is being conducted in Belgium, Brazil, Colombia, the Philippines, and South Africa in participants ≥ 12 years of age. Participants were randomly assigned to receive 2 doses of SCB-2019 or placebo administered intramuscularly 21 days apart. Here, we present the safety results of SCB-2019 over the 6-month period following 2-dose primary vaccination series in all adult participants (≥18 years of age).
A total of 30,137 adult participants received at least one dose of
study vaccine (n = 15,070) or placebo (n = 15,067) between 24 March 2021 and 01 December 2021. Unsolicited adverse events, medically-attended adverse events, adverse events of special interest, and serious adverse events were reported in similar frequencies in both
study arms over the 6-month follow-up period. Vaccine-related SAEs were reported by 4 of 15,070 SCB-2019 recipients (hypersensitivity reactions in two participants, Bell\'s palsy, and spontaneous abortion) and 2 of 15,067 placebo recipients (COVID-19, pneumonia, and acute respiratory distress syndrome in one participant and spontaneous abortion in the other one). No signs of vaccine-associated enhanced disease were observed.
SCB-2019 administered as a 2-dose series has an acceptable safety profile. No safety concerns were identified during the 6-month follow-up after the primary vaccination.
NCT04672395; EudraCT: 2020-004272-17.