- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03220048
Study Examining PrEP-001 in Healthy Subjects
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
At day 28, end of study visit, volunteers seen and assessed by a study physician for well-being, on-going symptoms and adverse events.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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London, United Kingdom, e1 2ax
- hVIVO Services Ltd, QMB Bioenterprise building
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Cohort A: Sentinel Group
Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0.
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Other Names:
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EXPERIMENTAL: 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.
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Other Names:
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EXPERIMENTAL: 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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Efficacy Endpoint: The Area Under the Curve (AUC) of Total Symptom Score From Day 1 (Post Viral Challenge) to Day 8 (Quarantine Discharge).
Time Frame: 8 days
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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. |
8 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Efficacy Endpoint: Symptom Scores: Peak Symptoms Score
Time Frame: 8 days
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Using the scheduled protocol assessments from Day 1 to Day 8, this endpoint represented the highest total symptom score (defined as the sum of all 10 individual composite symptoms). The minimum value, for subjects who had no symptoms, would be 0. The maximum value would be 30. Higher scores indicate worse outcome than lower scores. |
8 days
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Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Viral Shedding
Time Frame: 8 days
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The number of subjects with viral shedding.
Viral shedding was measured by PCR, testing the nasopharyngeal swab samples.
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8 days
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Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Seroconversion
Time Frame: 8 days
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The number of subjects with seroconversion.
Seroconversion was measured by the ratio of Influenza A/Perth/16/2009 (H3N2) virus antibodies at follow-up versus pre-dose.
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8 days
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Secondary Efficacy Endpoint: Viral Load Parameters: Area Under the Curve (AUC) of Viral Load, as Measured by Nasopharyngeal Swab RT-qPCR.
Time Frame: 8 days
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Viral load data was supplied in Log10 Copies/mL.
These values were used to calculate the Area Under the Curve (AUC) of Viral Load for each subject.
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8 days
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Secondary Efficacy Endpoint: Total Weight of Nasal Discharge Produced Post Viral Challenge to Quarantine Discharge
Time Frame: 8 days
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Total weight of nasal discharge (in grams) was calculated as the sum of mucus weights taken from Day 1 (Post viral challenge) to Day 8 (Quarantine Discharge).
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8 days
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PrEP-CS-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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