NCT04690335已完成2 期
A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Prophylactic Efficacy of MV-012-968 Against Respiratory Syncytial Virus (RSV) Infection in the Virus Challenge Model.
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Frequency of symptomatic RSV infection, as defined as the occurrence of both:
研究概览
简要总结
The purpose of this research study is to evaluate whether the investigational, live attenuated, intranasally delivered vaccine MV-012-968 ('study vaccine') may have prophylactic efficacy against symptomatic RSV infection when administered to adults 18-45 years of age in the Human Viral Challenge model.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An informed consent document signed and dated by the participant and the Investigator.
- •Aged between 18 and 45 years old on the day of signing the consent form.
- •In good general health with no history, or current evidence, of clinically significant medical conditions (including respiratory, cardiac and immunodeficiency), and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination (including vital signs), electrocardiogram (ECG), and routine laboratory tests as determined by the Investigator.
- •A documented medical history prior to enrolment.
- •Females of child bearing potential must have a negative pregnancy test prior to enrollment.
- •Females and Males must agree to adhere to the highly effective contraceptive requirements of the study from 2 weeks prior to the first study visit until 90 days after the date of study vaccination.
- •Sero-suitable to the challenge virus, as defined in the study Analytical Plan.
排除标准
- •History of symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit
- •Rhinitis which is clinically active
- •History of moderate to severe rhinitis
- •Acute sinusitis during Screening
- •Use of corticosteroid in respiratory tract (e.g. nasal or inhaled steroid) in the 30 days leading up to study vaccination
- •Females who are breastfeeding or have been pregnant within 6 months prior to the study
- •Participants who have smoked ≥ 10 pack years at any time [10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years])
- •Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test
- •Those employed or immediate relatives of those employed at hVIVO or the Sponsor
- •Participants may not live or work in direct close contact with, or live with anyone whose work brings them into direct close contact with, children under 2 years of age
- •Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study
研究组 & 干预措施
Placebo
Placebo Comparator
Sodium Chloride 0.9% w/v intravenous infusion B.P (Normal Saline) matched to reference article product, given intranasally.
干预措施: Placebo (Other)
MV-012-968
Experimental
Dose: 1 x10^6 Plaque Forming Unit (PFU), given intranasally, followed approximately 28 days later by inoculation with RSV-A (Memphis 37b).
干预措施: MV-012-968 (Biological)
结局指标
主要结局
Frequency of symptomatic RSV infection, as defined as the occurrence of both:
时间窗: 10 days (days 2 to 12)
* At least 1 quantifiable plaque assay sample in nasal wash specimens and * Symptoms meeting either: (i) a symptom of any grade from 2 different symptom categories from the participant Symptom Diary Card \[SDC\] (Upper Respiratory, Lower Respiratory, Systemic) or (ii) at least 1 Grade 2 upper or lower respiratory symptom from the participant SDC
次要结局
- Frequency of symptomatic RSV infection, as defined as occurrence of both:(10 days (days 2 to 12))
- Frequency of RSV infection, as defined as the occurrence of 2 quantifiable RT-qPCR samples on 2 consecutive days (i.e. at least 1 on each of 2 consecutive days) in nasal wash specimens(10 days (Day 2 to 12))
- Frequency of RSV infection, as defined as the occurrence of at least 1 quantifiable plaque assay sample in nasal wash specimens(10 days (Day 2 to 12))
- Mean daily total symptom score using the SDC(10 days (Day 2 to 12))
- Mean daily weight of nasal (mucus) discharge(10 days (Day 2 to 12))
- RSV load Area Under the Curve (AUC), as measured by RT-qPCR analysis of nasal wash specimens(10 days (Day 2 to 12))
- Peak RSV load, as measured by RT-qPCR of nasal wash specimens(10 days (Day 2 to 12))
- Frequency of solicited adverse events (AEs) as reported in the Subject Vaccination Diary Card, categorized by severity. Solicited AEs are predefined AEs that may occur after study vaccine administration.(Time Frame: 7 days (Day -28 to -21))
- Frequency of unsolicited AEs after study vaccination, categorized by severity and by study vaccine relatedness.(28 days (Day -28 to 0))
- Frequency of unsolicited AEs after RSV-A challenge, categorized by severity and by study vaccine relatedness.(29 days (Day 0 to 28))
- Frequency of serious AEs (SAEs) after study vaccination, categorized by study vaccine relatedness.(180 days (Day -28 to 152))
- Frequency of medically attended AEs (MAEs) after study vaccination, categorized by study vaccine relatedness.(180 days (Day -28 to 152))
研究者
研究点 (1)
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