A Phase Ia, Dose-finding Study to Assess the Safety and Immunogenicity of an Orf Virus-based COVID-19 Vaccine Booster (Prime-2-CoV_Beta) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Proportion of participants with unsolicited treatment-emergent adverse events throughout the study
研究概览
简要总结
This is an open-label, first-in-human, dose-finding study to evaluate the safety and immunogenicity of a booster vaccination of Prime-2-CoV_Beta in healthy participants who had received the full course of vaccination, including booster vaccination (i.e., having received 3 doses) with the Pfizer/BioNTech-BNT162b2 vaccine (Comirnaty).
详细描述
Eligible participants will undergo baseline assessments and will receive 1 injection of Prime-2-CoV_Beta at Day 1. Participants will be followed up through 6 months post-booster vaccination. Follow-up visits will be performed at Days 4, 8, 15, 29, and Months 3 and 6, to assess the safety, tolerability, and immunogenicity of Prime-2-CoV_Beta. Additional safety and tolerability data will be assessed 1 day and 2 days after booster vaccination (Days 2 and 3) by telephone. A total of 60 participants is planned to be vaccinated in 5 cohorts of 12 participants each. Dose ranging of Prime-2-CoV_Beta will be done by dose escalation with doses ranging from 3x10000 plaque forming units (PFUs) up to 3x10 000 000 PFUs
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Prime-2-CoV_Beta, dose: 30 000 PFUs
干预措施: Prime-2-CoV_Beta (Biological)
Cohort 2
Prime-2-CoV_Beta, dose: 300 000 PFUs
干预措施: Prime-2-CoV_Beta (Biological)
Cohort 3
Prime-2-CoV_Beta, dose: 3 000 000 PFUs
干预措施: Prime-2-CoV_Beta (Biological)
Cohort 4
Prime-2-CoV_Beta, dose: 150 000 000 PFUs
干预措施: Prime-2-CoV_Beta (Biological)
Cohort 5
Prime-2-CoV_Beta, dose: 30 000 000 PFUs
干预措施: Prime-2-CoV_Beta (Biological)
结局指标
主要结局
Proportion of participants with unsolicited treatment-emergent adverse events throughout the study
时间窗: Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)
All unsolicited adverse events which occur after the first administration of investigational product are defined as treatment-emergent adverse events. Treatment-emergent adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.
Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study
时间窗: Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)
All safety data will be summarized descriptively overall and by cohort. TEAEs will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.
Proportion of participants with solicited local adverse events (first 7 days after Prime-2-CoV_Beta booster vaccination): pain at injection site, redness, induration, and swelling.
时间窗: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)
Solicited local adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events).
Proportion of participants with solicited systemic adverse events (first 7 days after Prime-2-CoV_Beta booster vaccination): fever, fatigue, headache, chills, vomiting, nausea, diarrhea, new or worsened muscle pain, new or worsened joint pain.
时间窗: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)
Solicited systemic adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events).
次要结局
- Geometric mean titers (GMT) of receptor-binding protein-specific IgG antibodies(Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days))
- Proportion of participants with adverse events of special interest throughout the study(Day 1 (vaccination day) to day 8 (Visit 3; ±1 day))
- Level of neutralizing antibody titers versus SARS CoV-2 (Wuhan wild type) at each post-booster vaccination assessment(Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days))
- Geometric mean fold rise (GMFR) of neutralizing antibodies (versus Wuhan wild type) from Baseline to each post-booster vaccination assessment(Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days))
- IgG antibody titer versus SARS-CoV-2 receptor-binding protein(Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days))
- Geometric mean fold rise of receptor-binding protein-specific IgG antibodies from Baseline(Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days))
研究者
Sponsor Clinical Trial Contact
Scientific
Universitaetsklinikum Tuebingen AöR