First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating the Safety and Immunogenicity of IVT Shigella-04 in Healthy Young Adults
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of participants with reactogenicity events for 7 days after each dose
研究概览
简要总结
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
详细描述
A phase 1 single-site, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety and immunogenicity of a 2-dose regimen of IM injection of 5 dose formulations of IVT Shigella-04 vaccine with and without adjuvant among 60 healthy individuals aged 18 to 49 years. Approximately 12 eligible participants will be enrolled in the specified 5 sequential dose cohorts and randomized in a 5:1 ratio to receive 2 IM injections of IVT Shigella-04 or placebo (normal saline) at a 28-day interval.
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
- Double (Participant, Investigator)
盲法说明
Subjects and investigators will be blinded to treatment assignment. The vaccine and placebo will be prepared and administered by dedicated unblinded staff not involved in other aspects of the study and will be concealed from the participant at the time of dosing. Unblinding will occur only after database lock or in the event of a medical emergency requiring knowledge of treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 49 Years（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
Shigella-04 Low Dose without adjuvant (0.5 mL dose)
Subjects will receive a 0.5 mL dose of the Shigella-04 low-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29
干预措施: IVT Shigella-04 (Biological)
Shigella-04 Low Dose with adjuvant (0.5 mL dose)
Subjects will receive a 0.5 mL dose of the Shigella-04 low-dose formulation of each conjugated OPS, with adjuvant, administered via intramuscular injection on Day 1 and 29
干预措施: IVT Shigella-04 (Biological)
Shigella-04 Medium Dose without adjuvant (0.5 mL dose)
Subjects will receive a 0.5 mL dose of the Shigella-04 medium-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29
干预措施: IVT Shigella-04 (Biological)
Shigella-04 Medium Dose with adjuvant (0.5 mL dose)
Subjects will receive a 0.5 mL dose of the Shigella-04 medium-dose formulation of each conjugated OPS, with adjuvant, administered via intramuscular injection on Day 1 and 29
干预措施: IVT Shigella-04 (Biological)
Shigella-04 High Dose without adjuvant (1.0 mL dose)
Subjects will receive a 1.0 mL dose of the Shigella-04 high-dose formulation of each conjugated OPS, and administered via intramuscular injection on Day 1 and 29
干预措施: IVT Shigella-04 (Biological)
Placebo - 0.9% Saline
0.9% saline
干预措施: Placebo (0.9% saline) (Biological)
结局指标
主要结局
Percentage of participants with reactogenicity events for 7 days after each dose
时间窗: 7 days after Doses 1 and 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 2
时间窗: After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with medically attended AE's (MAAEs) from Dose 1 to 6 months after Dose 2
时间窗: After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from Dose 1 to 6 months after Dose 2
时间窗: After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with AEs of special interest (AESIs) from Dose 1 to 6 months after Dose 2
时间窗: After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
Percentage of participants with serious AEs (SAEs) from Dose 1 to 6 months after Dose 2
时间窗: After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
次要结局
- Percentage of participants achieving 4-fold increase in anti-IpaB and serotype-specific anti-OPS immunoglobulin G (IgG) concentration at 28 days after each dose and 6 months after Dose 2(At 28 days after each dose and 6 months after Dose 2)
- Geometric mean concentration (GMCs) of anti-IpaB and serotype-specific anti-OPS IgG at 28 days after each dose and 6 months after Dose 2(At 28 days after each dose and 6 months after Dose 2)
- Geometric mean fold rises (GMFRs) in anti-IpaB and serotype-specific anti-OPS IgG concentration at 28 days after each dose and 6 months after Dose 2(At 28 days after each dose and 6 months after Dose 2)
- Percentage of participants achieving 4-fold increase in serotype-specific anti-OPS functional antibody titer measured by serum bactericidal assay (SBA) at 28 days after each dose(At 28 days after each dose)
- Geometric mean titers (GMTs) of serotype-specific anti-OPS functional antibody as measured by SBA at 28 days after each dose(At 28 days after each dose)
- GMFRs in serotype-specific anti-OPS functional antibody titer as measured by SBA at 28 days after each dose(At 28 days after each dose)