一项3期随机、观察者盲法、安慰剂对照试验，评估研究性SARS-CoV-2 mRNA疫苗CVnCoV在德国美因茨成年医护人员中的安全性和免疫原性。
A phase 3, randomised, observer-blinded, placebo controlled-trial evaluating the safety and immunogenicity of investigational SARS-CoV-2 mRNA vaccine CVnCoV in adult healthcare workers in Mainz (Germany).
作者信息
Kowalzik Frank, Teschner Daniel, Mesquita Margarida, Jensen Christian, Schreiner Daniel, Kronfeld Kai, Tubic-Grozdanis Marija, Cheatham-Seitz Darline, Hettich Franziska, Quintini Gianluca, Schoenborn-Kellenberger Oliver, Codó Paula, von Eisenhart-Rothe Philipp, Mann Philipp, Oostvogels Lidia, Gehring Stephan
机构信息
Children's Hospital, University Medical Center of the Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, D-55131, Mainz, Germany.
Department of Hematology, and Medical Oncology, University Medical Center of the Johannes Gutenberg-Universität Mainz, Langenbeckstr. 1, D-55131, Mainz, Germany.
出版信息
Vaccine X. 2024 Jun 20;19:100512. doi: 10.1016/j.jvacx.2024.100512. eCollection 2024 Aug.
BACKGROUND
CV-NCOV-005 was conducted to generate additional safety and immunogenicity data for the former CVnCoV SARS-CoV-2 mRNA vaccine candidate in healthcare workers (HCW).
METHODS
Randomised, observer blinded, placebo-controlled, phase 3 trial performed at the University Medical Center Mainz, Germany. HCWs aged ≥18 years with no history of SARS-CoV-2 infection/positive serology were randomly assigned to receive two doses of CVnCoV, or two doses of placebo (0.9% NaCl). The primary objectives were to expand the safety database of CVnCoV and assess antibody responses against SARS-CoV-2. Primary safety and reactogenicity outcomes included solicited adverse events (AEs) within 7 days after each dose and unsolicited AEs within 28 days after each dose, with safety follow-up for 13 months after first vaccination. Since HCWs became eligible to receive an authorised vaccine during enrolment and efficacy results from HERALD CVnCoV trial were made available on 30 of June 2021, this study was unblinded and converted to an open label design.
RESULTS
Most participants in the CVnCoV group reported at least one solicited AE, a relatively high number being Grade 3 (43.3% in CVnCoV group and 6.4% in placebo group). Most AEs were short in duration and did not affect vaccine compliance. The percentage of participants with unsolicited AEs up to 28 days after any dose was slightly higher in CVnCoV group (37.0%) compared with placebo group (31.2%). IgG binding antibodies against the receptor binding domain of the SARS-CoV-2 spike protein were observed after vaccination, with higher seroconversion rates and antibody levels after the second dose.
CONCLUSION
No safety concerns for CVnCoV were identified up to 1 year post second dose. IgG responses against SARS-CoV-2 were observed after two doses, with a higher seroconversion rate and antibody levels observed after second vaccination.Study registration: ClinicalTrials.gov NCT04674189, study period: 23 of December 2020 to 8 of June 2022.
背景
开展CV-NCOV-005研究，以获取关于此前的CVnCoV新冠病毒mRNA候选疫苗在医护人员中的更多安全性和免疫原性数据。
方法
在德国美因茨大学医学中心进行的随机、观察者盲法、安慰剂对照3期试验。年龄≥18岁且无新冠病毒感染史/血清学检测呈阳性的医护人员被随机分配接受两剂CVnCoV或两剂安慰剂（0.9%氯化钠）。主要目标是扩大CVnCoV的安全性数据库，并评估针对新冠病毒的抗体反应。主要安全性和反应原性结局包括每剂接种后7天内的主动报告不良事件（AE）和每剂接种后28天内的非主动报告AE，并在首次接种后进行13个月的安全性随访。由于医护人员在入组期间有资格接种已获授权的疫苗，且HERALD CVnCoV试验的疗效结果于2021年6月30日公布，本研究揭盲并转换为开放标签设计。
结果
CVnCoV组的大多数参与者报告了至少一项主动报告AE，其中3级AE的数量相对较多（CVnCoV组为43.3%，安慰剂组为6.4%）。大多数AE持续时间较短，未影响疫苗接种依从性。CVnCoV组在任何一剂接种后28天内出现非主动报告AE的参与者百分比（37.0%）略高于安慰剂组（31.2%）。接种疫苗后观察到针对新冠病毒刺突蛋白受体结合域的IgG结合抗体，第二剂接种后的血清转化率和抗体水平更高。
结论
在第二剂接种后1年内未发现CVnCoV存在安全性问题。两剂接种后观察到针对新冠病毒的IgG反应，第二次接种后的血清转化率和抗体水平更高。研究注册号：ClinicalTrials.gov NCT04674189，研究期：2020年12月23日至2022年6月8日。
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