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| Name | Class |
|---|---|
| Prep Biopharm Limited | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Sentinel Group | Other | Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0. |
|
| Cohort B: PrEP-001 | Experimental | 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. |
|
| Cohort B: Placebo | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrEP-001 | Drug |
|
| |
| Placebo Comparator |
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Efficacy Endpoint: Symptom Scores: Peak Symptoms Score | 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. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Efthimiou | Sponsor's representative | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hVIVO Services Ltd, QMB Bioenterprise building | London | E1 2AX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29567461 | Derived | Malcolm BA, Aerts CA, Dubois KJ, Geurts FJ, Marien K, Rusch S, Van Dijck AH, Verloes R, Vingerhoets J. PrEP-001 prophylactic effect against rhinovirus and influenza virus - RESULTS of 2 randomized trials. Antiviral Res. 2018 May;153:70-77. doi: 10.1016/j.antiviral.2018.03.005. Epub 2018 Mar 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Sentinel Group | Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Sentinel Group | Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Deviation | score*mins | 8 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A: Sentinel Group | Sentinel group in which subjects received a challenge virus inoculum volume of 100uL on Day 0. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim Sharpington | hVIVO | 02071480862 | t.sharpington@hvivo.com |
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| ID | Term |
|---|---|
| C000600709 | G004 compound |
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| Other |
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| 8 days |
| Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Viral Shedding | The number of subjects with viral shedding. Viral shedding was measured by PCR, testing the nasopharyngeal swab samples. | 8 days |
| Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Seroconversion | 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. | 8 days |
| Secondary Efficacy Endpoint: Viral Load Parameters: Area Under the Curve (AUC) of Viral Load, as Measured by Nasopharyngeal Swab RT-qPCR. | 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. | 8 days |
| Secondary Efficacy Endpoint: Total Weight of Nasal Discharge Produced Post Viral Challenge to Quarantine Discharge | 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). | 8 days |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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, or 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. PrEP-001 |
| OG002 | Cohort B: Placebo | Placebo Comparator |
|
|
| Secondary | Secondary Efficacy Endpoint: Symptom Scores: Peak Symptoms Score | 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. | Posted | Mean | Standard Deviation | Score | 8 days |
|
|
|
| Secondary | Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Viral Shedding | The number of subjects with viral shedding. Viral shedding was measured by PCR, testing the nasopharyngeal swab samples. | Posted | Count of Participants | Participants | 8 days |
|
|
|
| Secondary | Secondary Efficacy Endpoint: Incidence(s) of Illness and Infection: Seroconversion | 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. | Posted | Count of Participants | Participants | 8 days |
|
|
|
| Secondary | Secondary Efficacy Endpoint: Viral Load Parameters: Area Under the Curve (AUC) of Viral Load, as Measured by Nasopharyngeal Swab RT-qPCR. | 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. | Posted | Mean | Standard Deviation | mins*log10 copy number/mL | 8 days |
|
|
|
| Secondary | Secondary Efficacy Endpoint: Total Weight of Nasal Discharge Produced Post Viral Challenge to Quarantine Discharge | 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). | Posted | Mean | Standard Deviation | grams | 8 days |
|
|
|
| 0 |
| 11 |
| 10 |
| 11 |
| EG001 | 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. | 0 | 27 | 17 | 27 |
| EG002 | 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. | 0 | 28 | 21 | 28 |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood fibrinogen increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Nervous system disorders | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Infections and infestations | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
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