A Phase 1, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of VAL-181388 in Healthy Adults in a Non-endemic Chikungunya Region
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Part A: Number of Participants With Unsolicited AEs
研究概览
简要总结
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.
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
Double Blind
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
- •18 to 49 years of age
- •Body mass index between 18 and 35 kilograms (kg)/square meter (m^2)
- •In good health as determined by medical history
- •Female participants must be non pregnant and non lactating and meet one of the following criteria: a) post menopausal b) surgically sterile, or c) of childbearing potential and agree to use an adequate contraception method
- •Male participants must use an acceptable method of birth control through 3 months after the final vaccination
- •Agrees to comply with the study procedures and provides written informed consent
- •Has access to a consistent and reliable means of telephone contact and agrees to stay in contact with the study site for the duration of the study
排除标准
- •Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- •Female of childbearing potential and has a positive pregnancy test at screening or on the day of vaccination
- •Abnormal vital signs or screening safety laboratory test results including liver enzyme tests
- •Administration of an investigational product within 60 days, or 5 half-lives, whichever is longer
- •Administration of any live attenuated vaccines within 4 weeks before enrollment or inactive vaccines within 2 weeks before enrollment, or plans to receive any vaccine during the active vaccination period
- •Prior administration of a vaccine for chikungunya virus (CHIKV), dengue, Yellow Fever, tick-borne encephalitis, a history of confirmed or suspected CHIKV infection, or has lived in a CHIKV-endemic area greater than 1 year or cumulative stay of greater than 30 days in 5 years
- •Prior administration of investigational agent using formulations similar to VAL-181388
- •A history of hypersensitivity or serious reactions to previous vaccinations
- •Any known or suspected autoimmune disease or immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination
- •A history of inflammatory arthritis
- •Any neurologic disorder
- •Prior administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study drug or plans to receive such products at any time during the study
- •Any chronic administration of an immunosuppressant or other immune modifying drug
- •Daily or every other day administration of antipyretic or analgesic medication
- •Any acute illness at the time of enrollment
- •Any significant disorder of coagulation requiring ongoing or intermittent treatment
- •A history of idiopathic urticaria
- •A history of alcohol abuse or drug addiction
- •A positive test result for drugs of abuse
- •The participant has any abnormality or permanent body art (for example, tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site
- •Any condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study drug or interpretation of study results
- •A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies
- •A history of active cancer (malignancy) in the last 10 years
- •Donation of blood or blood products >450 milliliters (mL) within 30 days of dosing
- •Is an employee or first degree relative of the Sponsor, clinical research organization (CRO), or study site personnel
结局指标
主要结局
Part A: Number of Participants With Unsolicited AEs
时间窗: 28 days following each vaccination
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest
时间窗: 28 days following each vaccination
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Part B: Number of Participants With SAEs and AEs of Special Interest
时间窗: Through 1 year following the last vaccination
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events)
时间窗: 7 days following each vaccination
Solicited AEs, including local and systemic AEs were recorded by participants daily using the memory aid. Solicited local AEs include injection site induration/swelling, injection site tenderness, injection site erythema/redness, and injection site pain. Solicited systemic AEs include body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, and diarrhea. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
次要结局
未报告次要终点