A Randomized, Observer-Blind, Phase 2 Study To Assess the Safety and Immunogenicity of CRV-101 Vaccine Head-To-Head With SHINGRIX® for the Prevention of Herpes Zoster in Adults Aged 50 Years and Older
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Curevo Inc
- 入组人数
- 1,516
- 试验地点
- 1
- 主要终点
- Occurrence of serious adverse events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety and immunogenicity of amezosvatein (CRV-101), an investigational vaccine compared to Shingrix® for the prevention of herpes zoster in adults aged 50 years and older
详细描述
In the first part of the trial, participants will be randomized 1:1:1 to amezosvatein high antigen dose (Arm A), amezosvatein low antigen dose (B), or Shingrix (C). In the second part of the trial, participants will be randomized 5:1 to receive amezosvatein adjuvant dose D or Shingrix (E), adjuvant dose F or Shingrix (G), or adjuvant dose H or Shingrix (I). In the third part of the trial, participants will be randomized 3:1 to receive amezosvatein adjuvant dose J or Shingrix (K) or amezosvatein adjuvant dose L or Shingrix (M). Both study vaccines, amezosvatein and Shingrix, will be administered by intramuscular injection on Month 0 and Month 2. Safety, reactogenicity, and immunogenicity analysis will be performed overall and by age group. Participants will be followed for safety, immunogenicity, and herpes zoster cases from Day 0 to the main study end (Month 14), and through the long-term follow up (LTFU) extension period of up to 5 additional years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
Arm A
Investigational Vaccine
干预措施: Amezosvatein Antigen High Dose Arm A (Biological)
Arm B
Investigational Vaccine
干预措施: Amezosvatein Antigen Low Dose Arm B (Biological)
Arm C
Active comparator
干预措施: Shingrix (Biological)
Arm D
Investigational Vaccine
干预措施: Amezosvatein Adjuvant Dose Arm D (Biological)
Arm E
Active Comparator
干预措施: Shingrix (Biological)
Arm F
Investigational Vaccine
干预措施: Amezosvatein Adjuvant Dose Arm F (Biological)
Arm G
Active Comparator
干预措施: Shingrix (Biological)
Arm H
Investigational Vaccine
干预措施: Amezosvatein Adjuvant Dose Arm H (Biological)
I
Active Comparator
干预措施: Shingrix (Biological)
Arm J
Investigational Vaccine
干预措施: Amezosvatein Adjuvant Dose Arm J (Biological)
Arm K
Active Comparator
干预措施: Shingrix (Biological)
Arm L
Investigational Vaccine
干预措施: Amezosvatein Adjuvant Dose Arm L (Biological)
Arm M
Active Comparator
干预措施: Shingrix (Biological)
结局指标
主要结局
Occurrence of serious adverse events (SAEs)
时间窗: Day 0 - Day 421 [Month 14] (as noted in description)
Occurrence and relationship to vaccination of all serious adverse events (SAE) from after first vaccination (Day 0) to main study end (Day 421 \[Month 14\])
Occurrence of solicited local and systemic signs and symptoms
时间窗: Day 0-Day 6 for each vaccination timepoint
Occurrence, severity, and duration of solicited local injection site reactions within 7 days (Day 0-Day 6) following each vaccination. (i.e., pain, redness, swelling) Occurrence, severity, and duration of solicited systemic reactions within 7 days (Day 0-Day 6) following each vaccination. (i.e., myalgia, fatigue, headache, chills, fever)
To compare the reactogenicity of amezosvatein to that of the standard 2-dose schedule of Shingrix®
时间窗: Day 0-Day 6 for each vaccination timepoint
Comparison of the proportion of participants reporting solicited local and systemic reactogenicity events following each vaccination
Occurrence of unsolicited non-serious adverse events
时间窗: Day 0-Day 28 following each vaccination
Occurrence, severity, and relationship to vaccination of unsolicited adverse events within 29 days (Day 0-Day 28) following each vaccination
Occurrence of adverse events (AEs) of special interest
时间窗: Day 0 - Day 421 [Month 14] (as noted in description)
Occurrence of any Potential Immune-Mediated Medical Conditions (PIMMCs) from post first vaccination (Day 0) to main study end (Day 421 \[Month 14\]) Medically attended adverse events (MAAEs) from post first vaccination (Day 0) to study end (Day 421 \[Month 14\])
To evaluate safety as measured by hematology and biochemistry parameters
时间窗: Day 7 and Day 63
Occurrence, intensity, and relationship to vaccination of clinically significant hematologic and biochemical adverse events at at Day 7 and Day 63
Vaccine protein-specific antibody concentrations (GMC) elicited by vaccination between Month 0 and Month 3
时间窗: Month 3
Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
Vaccine Response Rate (≥ 4 fold increase in antibody concentration from pre-vaccination) at Month 3 for arms A, B, and C
时间窗: Month 3
• Assess humoral immune response as determined by Enzyme-linked Immunosorbent Assay (ELISA)
To compare the humoral immune response of Shingrix® to amezosvatein
时间窗: Month 3
Comparison of humoral response between amezosvatein and Shingrix at Month 3
次要结局
- Fold rise of vaccine protein-specific antibody concentrations elicited in response to vaccination for durability post Month 3(Month 3)
- Anti-Varicella Zoster Virus (VZV) neutralizing antibody titer in response to vaccination between Day 0 and Month 3 for arms A, B, and C(Month 3)
- Frequency of vaccine protein-specific CD4+ T cells expressing at least 2 activation markers in response to vaccination between Month 0 and Month 3 for arms A, B, and C(Month 3)
- To compare the frequency of vaccine protein-specific CD4+ T cells expressing at least 2 activation markers of Shingrix® to amezosvatein between Month 0 and Month 3 for arms A, B, and C.(Month 3)
- CMI Vaccine Response rate (≥ 2-fold increase in the frequency of vaccine protein-specific CD4+ T cell expressing at least 2 activation markers) at Month 3 for arms A, B, and C.(Month 3)
- Vaccine Response Rate (≥ 4 fold increase in antibody concentration from pre-vaccination) at Month 3 for arms D through M(Month 3)