A Phase II, Repeated Dose, Double-Blinded, Randomised, Controlled Study to Examine the Prophylactic Efficacy, Safety and Tolerability of PrEP-001 in Healthy Subjects Subsequently Challenged With Influenza A/Perth/16/2009 (H3N2) Virus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Hvivo
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint: The Area Under the Curve (AUC) of Total Symptom Score From Day 1 (Post Viral Challenge) to Day 8 (Quarantine Discharge).
研究概览
简要总结
Phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.
详细描述
Screening took place up to 90 days before quarantine. Volunteers completed an informed consent and underwent screening assessments to determine their eligibility.
There were 2 study groups:
Cohort A: (Sentinel): determined the Challenge Virus infection rate after inoculation with Influenza Virus on Day 0. There was 12 subjects (open label, no randomisation) invited to attend Quarantine on Day -2 or -1.
Cohort B: Examined the prophylactic efficacy, safety and tolerability of PrEP-001 compared to placebo (randomised 1:1). Subjects attended on Day -4/-3, dosed with PrEP-001 or Placebo on Day -2 AND Day-1 and then challenged with virus (volume confirmed from Cohort A) on Day 0.
Volunteers remained in quarantine unit for 8 days after inoculation.
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
- •Female subjects were required to provide of a history of reliable contraceptive practice.
- •Exclusion criteria:
- •Subjects who have a significant history of any tobacco use at any time.
- •Any history or evidence of any clinically significant cardiovascular, dermatological gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal disease.
- •Abnormal ECG
排除标准
- 未提供
研究组 & 干预措施
Cohort A: Sentinel Group
Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0.
干预措施: Placebo Comparator (Other)
Cohort B: PrEP-001
PrEP-001 6400μg dose administered equally over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
干预措施: PrEP-001 (Drug)
Cohort B: Placebo
Nasal dose of placebo Comparator equally divided over both nostrils and on 2 consecutive days, using a single dose nasal powder device, as per randomisation schedule.
干预措施: Placebo Comparator (Other)
结局指标
主要结局
Primary Efficacy Endpoint: The Area Under the Curve (AUC) of Total Symptom Score From Day 1 (Post Viral Challenge) to Day 8 (Quarantine Discharge).
时间窗: 8 days
Area Under the Curve (AUC) of total symptom scores (upper respiratory tract (URT), lower respiratory tract (LRT) and systemic viral symptoms (SVS)). Total symptom scores (from the symptom diary card) were used to calculate the AUC. The time unit used was minutes. Thus, the AUC unit is the total symptom score multiplied by the time period from first to last assessment in minutes (i.e score\*mins). The minimum AUC value would be 0, for a subject who did not report any symptoms. The maximum AUC value is not provided as it would be theoretical only, with no real meaning in terms of severity. Higher scores indicate worse outcome than lower scores.
次要结局
- Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Viral Shedding(8 days)
- Secondary Efficacy Endpoint: Total Weight of Nasal Discharge Produced Post Viral Challenge to Quarantine Discharge(8 days)
- Secondary Efficacy Endpoint: Symptom Scores: Peak Symptoms Score(8 days)
- Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Seroconversion(8 days)
- Secondary Efficacy Endpoint: Viral Load Parameters: Area Under the Curve (AUC) of Viral Load, as Measured by Nasopharyngeal Swab RT-qPCR.(8 days)