An Open-Label, Single Arm Trial To Evaluate Antibody Persistence And Long Term Safety Of A Live-Attenuated Chikungunya Virus Vaccine (VLA1553) In Adults Aged 18 Years and Above
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 363
- 试验地点
- 14
- 主要终点
- Proportion of participants with seroresponse levels post-vaccination. (defined as µPRNT50 ≥150)
研究概览
简要总结
In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety will be evaluated in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724).
详细描述
In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724)
These participants will have annual follow-up visits at Months 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 after immunization. The primary objective of this trial will be to evaluate persistence of antibodies annually from 1 to 10 years after the single immunization with VLA1553. The secondary objective is to evaluate long-term safety 6 months to 2 years after the single immunization with VLA1553.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individual participated in the VLA1553-301 clinical trial;
- •Participant has an understanding of the trial and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any trial-related procedures;
- •Participant had immunogenicity blood samples taken at baseline (Visit 1) and either Day 29 (Visit 3), Day 85 (Visit 4) or Day 180 (Visit 5) in Trial VLA1553-301 and was negative for neutralizing antibodies at baseline
排除标准
- •Participant presents with clinical conditions representing a contraindication to blood draws;
- •Participant has donated blood or use of blood products prior 30 days of immunogenicity sampling;
- •Participant has received an active drug with potential immunosuppressive action or investigational drug or device within a period of 30 days prior a trial visit;
- •Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
- •Participant has any condition that, in the opinion of the Investigator, may compromise the participant's well-being, might interfere with evaluation of trial endpoints, or would limit the participant's ability to complete the trial;
- •Participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
- •Participant is a member of the team conducting the trial or in a dependent relationship with one of the trial team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the trial.
研究组 & 干预措施
VLA1553
干预措施: VLA1553 (Biological)
结局指标
主要结局
Proportion of participants with seroresponse levels post-vaccination. (defined as µPRNT50 ≥150)
时间窗: until Year 10
次要结局
- Proportion of participants with seroconversion(until Year 10)
- Immune response as measured by CHIKV-specific neutralizing antibody titers post-vaccination(until Year 10)
- Frequency of any Serious Adverse Event (SAE)(until Year 2)
- Relatedness of any Serious Adverse Event (SAE)(until Year 2)
- Fold increase of CHIKV-specific neutralizing antibody titers post-vaccination as compared to baseline (i.e. at start of trial VLA1553-301)(until Year 10)
- Proportion of participants reaching an at least 4-fold, 8-fold, 16-fold or 64-fold increase in CHIKV-specific neutralizing antibody titer compared to baseline(until Year 10)