Phase 2, Single-arm, Open-label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular HIL-214 Norovirus Vaccine in Adults Aged 18 to 49 Years
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- HilleVax
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Primary Immunogenicity for Panel Formation
研究概览
简要总结
The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
详细描述
This single-arm trial serves to obtain serum for proficiency testing to confirm assay validity is maintained. Exploratory aspects of this trial include evaluating additional assays used for the assessment of immune responses to HIL-214 in peripheral-blood samples. Given the large volume of blood required, the pediatric dose will be tested in healthy adults. The main scientific rationale for the trial is to identify immune assays that can assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Male or female subjects aged 18 to 49 years, inclusive.
- •Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
- •The individual signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements.
- •Individuals willing and able to comply with trial procedures and are available for the duration of follow-up.
排除标准
- •Females who are pregnant or breastfeeding.
- •Gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration).
- •Known hypersensitivity or allergy to any of the HIL-214 components (including excipients).
- •Known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
- •Any serious chronic or progressive disease (including hepatitis B or C).
- •Previous exposure to an experimental norovirus vaccine.
- •Subject or subject's first-degree relatives are involved in the trial conduct.
研究组 & 干预措施
Open Arm Study
One dose given to all participants
干预措施: HIL-214 (Biological)
结局指标
主要结局
Primary Immunogenicity for Panel Formation
时间窗: Day 1 to Day 29
Serum samples were obtained for validation of the norovirus GI.1 and GII.4c histoblood group antigen (HBGA)-blocking and total immunoglobulin (pan-Ig) assays. The percentage of participants with a predefined seroresponse (≥4-fold rise in antibody concentration from Day 1 to Day 29) to the GI.1 and GII.4c components of HIL-214 and 95% confidence interval are reported.
次要结局
- Adverse Events Leading to Participant Withdrawal From the Trial(Day 1 to Day 85)
- Percentage of Participants With Solicited Local (Injection Site) Adverse Events Within 7 Days of Vaccine Administration(Day 1 to Day 7)
- Percentage of Participants With Solicited Systemic Adverse Events (AEs) Within 7 Days of Vaccine Administration(Day 1 to Day 7)
- Percentage of Participants With at Least One Unsolicited AEs After the Dose of Trial Vaccine(Day 1 to Day 28)