A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 20
- 主要终点
- Number of Participants with Solicited Injection Site Adverse Events (AEs)
研究概览
简要总结
Epstein Barr virus (EBV) is a virus which can cause infectious mononucleosis and is associated with certain kinds of cancer and multiple sclerosis. Researchers are looking for new ways to prevent disease related to EBV and have developed a new study vaccine (V350A and V350B). The main goal of this study is to learn about the safety and tolerability of V350A and V350B in healthy adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to the following:
- •Is in good health before randomization.
- •Has a body mass index between 18 and 38 kg/m^2, inclusive, for adults 18-30; has a body mass index between 15 and 38 kg/m^2, inclusive, for adolescents 12-17.
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a confirmed or suspected case of infectious mononucleosis within 12 months prior to enrollment.
- •Has any immunosuppressive medical condition or receive any immunosuppressive therapy.
研究组 & 干预措施
V350B
Participants will receive V350B vaccinations on Day 1, Month 2, and Month 6.
干预措施: V350B (Biological)
Placebo
Participants will receive placebo vaccinations on Day 1, Month 2, and Month 6.
干预措施: Placebo (Biological)
V350A
Participants will receive V350A vaccinations on Day 1, Month 2, and Month 6.
干预措施: V350A (Biological)
结局指标
主要结局
Number of Participants with Solicited Injection Site Adverse Events (AEs)
时间窗: Up to approximately 6 months
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs will be recorded on a vaccination report card (VRC).
Number of Participants with Solicited Systemic AEs
时间窗: Up to approximately 6 months
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will be recorded on a VRC.
Number of Participants with Immediate AEs Following Vaccinations
时间窗: Up to approximately 6 months
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Participants will be observed following vaccination for immediate AEs.
Number of Participants with Unsolicited AEs
时间窗: Up to approximately 7 months
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited AEs will be recorded on a VRC.
Number of Participants with Serious AEs
时间窗: Up to approximately 18 months
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.
Number of Participants with Medically Attended Adverse Events (MAAEs)
时间窗: Up to approximately 18 months
A MAAE is an AE in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered MAAEs.
Number of Participants with Events of Clinical Interest (ECIs)
时间窗: Up to approximately 18 months
ECIs are selected serious and nonserious AEs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs).
次要结局
- Geometric Mean Titers (GMT) of Immunoglobulin G (IgG) Antibodies Response Against Vaccine-matched Epstein Barr Virus (EBV) Antigens(Up to approximately 18 months)
- Geometric Mean Fold Rise (GMFR) of IgG Antibody Response against Vaccine-matched EBV Antigens(Baseline and up to approximately 18 months)