Phase 2
N=66
Study Examining PrEP-001 in Healthy Subjects
Influenza A H3N2
Bottom Line
View on ClinicalTrials.gov: NCT03220048 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Primary Efficacy Endpoint: The Area Under the Curve (AUC) of Total Symptom Score From Day 1 (Post Viral Challenge) to Day 8 (Quarantine Discharge). — 17956.5; 4502.6; 9859.6 score*mins
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PrEP-001 (Drug); Placebo Comparator (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hvivo
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Endpoint: The Area Under the Curve (AUC) of Total Symptom Score From Day 1 (Post Viral Challenge) to Day 8 (Quarantine Discharge). |
17956.5; 4502.6; 9859.6 | — |
| SECONDARY Secondary Efficacy Endpoint: Symptom Scores: Peak Symptoms Score |
5.2; 1.7; 3.3 | — |
| SECONDARY Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Viral Shedding |
7; 13; 21 | — |
| SECONDARY Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Seroconversion |
9; 12; 16 | — |
| SECONDARY Secondary Efficacy Endpoint: Viral Load Parameters: Area Under the Curve (AUC) of Viral Load, as Measured by Nasopharyngeal Swab RT-qPCR. |
33021.8; 23781.6; 32944.4 | — |
| SECONDARY Secondary Efficacy Endpoint: Total Weight of Nasal Discharge Produced Post Viral Challenge to Quarantine Discharge |
26.580; 3.959; 13.414 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03220048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.