Viral Upper Respiratory Tract InfectionPhase 2NCT03338556
A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16
A Phase 2 study testing PrEP-001 in people with Viral Upper Respiratory Tract Infection, run by Prep Biopharm Limited at 1 site in United Kingdom.
Trial summary
A study to examine the duration of effect of PrEP-001 in healthy subjects challenged with HRV-16 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Upper Respiratory Tract Infection
- What is being tested?
- PrEP-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 2016to 30 Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 55 years on the day of first dosing with Investigational Medicinal Product (IMP).
- In good health with no history of major medical conditions from the medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation. A subject with a history of Herpes type 1 or 2 infection may be included if there are no active lesions present and the subject is not taking active medication.
- A total body weight ≥50 kg and Body Mass Index (BMI) ≥18 kg/m2. If the BMI is more than 30 kg/m2, the subject may be included if the waist measurement is less than 102 cm (male), or less than 88 cm (female).
- The following inclusion criteria are applicable to subjects who are in a heterosexual relationship and female subjects in a female same sex relationship (i.e. the criteria do not apply to those in a male same sex relationship):
- True abstinence - when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
- Or
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- Two forms of effective contraceptive methods among (between) the couple, which are defined as:
- For males: i. Condom with spermicidal foam/gel/film/cream, sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate. This applies only to males participating in the study).
- For females: i. Women no longer of child bearing potential (post-menopausal females are defined as having a history of amenorrhea for at least 2 years, otherwise they should have documented status as being surgically sterile or post hysterectomy. The latter applies only to female subjects participating in the study).
- If of childbearing potential, then acceptable forms of contraception include:
- o Established (a minimum of 2 weeks prior to first dosing with IMP) use of oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception or occlusive cap (diaphragm or cervical/vault caps), both with one of the following - spermicidal foam/gel/film/cream/suppository.
- The longevity of contraception is as follows: i. Male subjects must comply with agreed contraception from the first IMP dosing, and continuing until 90 days after the date of the last IMP dosing or Viral Challenge which ever happens later.
- Male subjects must not donate sperm following the first IMP dosing, and continuing until 90 days after the date of the last IMP dosing or Viral Challenge which ever happens later.
- Female subjects of childbearing potential must have a negative pregnancy test at screening and just prior to the date of first dosing with IMP and must be using contraception consisting of two forms of birth control (one of which must be a barrier method) starting from at least 14 days prior to the first IMP dosing and continuing until 90 days after the date of the last IMP dosing or Viral Challenge whichever happens later.
- An informed consent document signed and dated by the subject and the Investigator.
- Sero-suitable for the Challenge Virus.
- Subjects must be willing to comply with the protocol visit schedule including both face to face and phone visits.
Who cannot join
- Subjects who have a significant history of any tobacco use at any time (total ≥10 pack year history [10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years]).
- Females who:
- Are breastfeeding, or
- Have been pregnant within 6 months prior to the study, or
- Have a positive pregnancy test at any point during screening or prior to first dosing with IMP
- Any history or evidence of any clinically significant cardiovascular, dermatological (including psoriasis), gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, renal, and/or other major disease that, in the opinion of the Investigator, may interfere with a subject completing the study. The following conditions apply:
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- Subjects with clinically mild atopic eczema/atopic dermatitis may be included at the Investigator's discretion (e.g., if there is no regular use of topical steroids, no eczema in cubital fossa)
- Subjects with any history of significant psychiatric illness should be excluded unless the illness resolved within 3 months, Subjects with a diagnosis of mild or moderate depressive episode(s) which occurred 2 or more years ago, with good evidence of preceding stressors and which resolved within approximately 3 months may be included in the Investigator's opinion
- During screening, if subjects have a total cholesterol level > 6mmol/l they will be excluded from the study.
- Any concurrent serious illness (e.g., COPD, history of malignancy) that may interfere with a subject completing the study. Basal cell carcinoma within 5 years of initial diagnosis or with evidence of recurrence is also an exclusion
- Abnormal pulmonary function in the opinion of the Investigator as evidenced by the responses to the respiratory screening questions and/or clinically significant abnormalities in spirometry (forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)).
- History or evidence of autoimmune disease or known immunodeficiency of any cause - with the exception of atopic eczema/atopic dermatitis as described in exclusion criterion number (3).
- Subjects with any history of COPD, pulmonary hypertension, asthma or chronic lung condition of any aetiology.
- A history of childhood asthma before the age of 12 years is acceptable provided the subject is asymptomatic without treatment. Subjects with a single episode of wheezing (lasting less than 8 weeks) after age 12 years can be included at the Investigator's discretion provided the episode was more than 4 years ago and did not require a hospital admission and/or oral/intravenous steroids.
- Positive HIV, active hepatitis A (HAV), B (HBV), or C (HCV) test.
- Any significant abnormality altering the anatomy of the nose or nasopharynx.
- Any clinically significant history of epistaxis (nosebleeds) within the last 12 months and/or a history of being hospitalized due to epistaxis on any previous occasion.
- Any nasal or sinus surgery within 6 months of first dosing (due to intranasal IMP).
- Recurrent history of fainting.
- Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the Investigator.
- Confirmed positive test for drugs of abuse or cotinine deemed by the Investigator to be clinically significant.
- Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
- Any clinically significant allergies such as allergy to the excipients in the Challenge Virus inoculum as stipulated in the protocol.
- Evidence of vaccinations within the 4 weeks prior to the planned date of first dosing with IMP or an intention to receive any vaccination(s) before the last day of the study.
- Those employed, or immediate relatives of those employed, at hVIVO or the Sponsor.
- Receipt of blood or blood products, or loss (including blood donations) of 450 mL or more of blood during the 3 months prior to the planned date of first dosing with IMP (whichever occurs first) or planned during the 3 months after the final visit.
- Use within 7 days prior to the planned date of first dosing with IMP of any medication or product (prescription or over-the-counter), for symptoms of hay fever, rhinitis, nasal congestion or respiratory tract infections including the use of nasal steroids.
- Receipt of any investigational drug within 3 months prior to the planned date of first dosing with IMP or receipt of three or more investigational drugs within the previous 12 months prior to the planned date of first dosing with IMP.
- Prior inoculation with a virus from the same virus-family as the Challenge Virus or prior participation in another Human Viral Challenge study with a respiratory virus in the preceding 12 months taken from the date of first dosing with IMP in the previous study to the date of expected first dosing in this study.
- Receipt of systemic (intravenous and/or oral) glucocorticoids or systemic antiviral drugs within 6 months prior to the planned date of first dosing with IMP. History of chemotherapy of therapy with immunomodulators.
- History suggestive of respiratory infection within 14 days prior to first dosing or presence of significant respiratory symptoms on the day of first dosing with IMP
- Use or anticipated use during the conduct of the study of concomitant medications (prescription and/or non-prescription), including vitamins or herbal and dietary supplements within the specified windows, unless in the opinion of the Investigator and/or Sponsor's Medical Expert, the medication will not interfere with the study procedures or compromise subject safety. Specifically, the following are excluded:
- Herbal supplements within 7 days prior to the planned date of first dosing with IMP
- Chronically used medications, vitamins or dietary supplements, including any medication known to be an inducer or inhibitor of cytochrome P450 (CYP450) enzymes, within 21 days prior to the planned date of dosing with IMP
- Over the counter medications (e.g., paracetamol or ibuprofen) where the dose taken over the preceding 7 days prior to the planned date of first dosing with IMP has exceeded the maximum permissible 24-hour dose (e.g., ≥4 g paracetamol over the preceding week)
- Any other finding that, in the opinion of the Investigator, deems the subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
hVIVO Services Limited, QMB Innovation Centre
London, E1 2AX
About this study
Official title: A Phase IIa, Randomised, Double-blind, Placebo-controlled Outpatients Study to Investigate the Duration of Effect and Safety of PrEP-001 Given Prophylactically in Healthy Subjects, Subsequently Challenged With Human Rhinovirus (HRV-16)
A study to examine the duration of effect of PrEP-001 in healthy subjects challenged with HRV-16
Read the detailed description
A phase IIa, randomised, double-blind, placebo-controlled study using outpatient setting to assess the prophylactic effect of repeated intranasal dosing of PrEP-001 in healthy subjects, subsequently challenged with HRV-16, on the changes in clinical symptoms when compared to placebo at two different dosing regimens
- Conditions
- Viral Upper Respiratory Tract Infection
- Being tested
- PrEP-001, Placebo
- Keywords
- Rhinovirus, Healthy volunteer, Outpatient, Cold virus, HRV-16
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP-001Drug
Also called Poly-IC
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - PrEP-001 | Active comparator | PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). Receives: Drug: PrEP-001 |
| Cohort A - Placebo | Placebo comparator | Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). Receives: Other: Placebo |
| Cohort B- PrEP-001 | Active comparator | PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). Receives: Drug: PrEP-001 |
| Cohort B - Placebo | Placebo comparator | Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Symptom Scores
Overall total symptom score (TSS), defined as the sum of the total symptom scores from day 1 to day 8 inclusive, using the 10-point symptom diary card on a 0 - 3 point scale
The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities:
Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache.
Diary cards were filled out 3 times/day on Day 1-7 and once on Day 8. Possible range of outcomes for TSS: 0 - 660 (higher numbers indicating worse outcomes)
Measured: 8 days
Secondary outcomes (2)
Area Under Curve of Symptom Scores
Total symptom scores (from the 10-item modified Jackson symptom diary card) were used to calculate the AUC, from Day 1 (Assessment 1) to Day 8, after challenge, for each subject using the trapezium rule, based on the available non-missing calculated total symptom scores between Day 1 (Assessment 1) and Day 8. The 10-point symptom diary card, measured three times daily was combined to generate total symptom score. The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities:
Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache
Measured: 8 days
Incidence(s) of Laboratory Confirmed Illness
The number of subjects with laboratory confirmed HRV-16 infection (as defined by a positive quantitative polymerase chain reaction (qPCR) result from the combined nasal washes of days 3, 4 and 5) who displayed clinical symptoms of upper respiratory tract (using the 10-item diary card, Day 1 to Day 8) - ITT analysis set
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start6 Apr 2016
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Viral Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prep Biopharm Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hvivo
- Responsible party
- Sponsor
- Investigators
- Cyrus Ghobadi, MD, Principal investigator, hVIVO Services Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338556
- Sponsor's protocol ID
- PrEP-CS-003
- Status last verified
- Nov 2018
- First submitted
- 20 Oct 2017
- Last updated
- 9 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa, Randomised, Double-blind, Placebo-controlled Outpatients Study to Investigate the Duration of Effect and Safety of PrEP-001 Given Prophylactically in Healthy Subjects, Subsequently Challenged With Human Rhinovirus (HRV-16)
- ClinicalTrials.gov ID
- NCT03338556
- Acronym / sponsor ID
- PrEP-CS-003
- Conditions
- Viral Upper Respiratory Tract Infection
- Keywords
- Rhinovirus, Healthy volunteer, Outpatient, Cold virus, HRV-16
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Prep Biopharm LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Hvivo
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 27 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to examine the duration of effect of PrEP-001 in healthy subjects challenged with HRV-16
Detailed description
A phase IIa, randomised, double-blind, placebo-controlled study using outpatient setting to assess the prophylactic effect of repeated intranasal dosing of PrEP-001 in healthy subjects, subsequently challenged with HRV-16, on the changes in clinical symptoms when compared to placebo at two different dosing regimens
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A - PrEP-001 | Active comparator | Drug: PrEP-001PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). |
| Cohort A - Placebo | Placebo comparator | Other: PlaceboPlacebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). |
| Cohort B- PrEP-001 | Active comparator | Drug: PrEP-001PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). |
| Cohort B - Placebo | Placebo comparator | Other: PlaceboPlacebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). |
Who may qualify
- Ages
- 18 to 55 years
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Aged 18 to 55 years on the day of first dosing with Investigational Medicinal Product (IMP).
- In good health with no history of major medical conditions from the medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation. A subject with a history of Herpes type 1 or 2 infection may be included if there are no active lesions present and the subject is not taking active medication.
- A total body weight ≥50 kg and Body Mass Index (BMI) ≥18 kg/m2. If the BMI is more than 30 kg/m2, the subject may be included if the waist measurement is less than 102 cm (male), or less than 88 cm (female).
- The following inclusion criteria are applicable to subjects who are in a heterosexual relationship and female subjects in a female same sex relationship (i.e. the criteria do not apply to those in a male same sex relationship):
- Or
Key exclusion criteria (36 listed)
- Subjects who have a significant history of any tobacco use at any time (total ≥10 pack year history [10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years]).
- Females who:
- Any history or evidence of any clinically significant cardiovascular, dermatological (including psoriasis), gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, renal, and/or other major disease that, in the opinion of the Investigator, may interfere with a subject completing the study. The following conditions apply:
- Abnormal pulmonary function in the opinion of the Investigator as evidenced by the responses to the respiratory screening questions and/or clinically significant abnormalities in spirometry (forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)).
- History or evidence of autoimmune disease or known immunodeficiency of any cause - with the exception of atopic eczema/atopic dermatitis as described in exclusion criterion number (3).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP-001Also: Poly-IC | Drug | Cohort A - PrEP-001, Cohort B- PrEP-001 |
| Placebo | Other | Cohort A - Placebo, Cohort B - Placebo |
Primary outcome
Total Symptom Scores
Time frame: 8 days
Overall total symptom score (TSS), defined as the sum of the total symptom scores from day 1 to day 8 inclusive, using the 10-point symptom diary card on a 0 - 3 point scale The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities: Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache. Diary cards were filled out 3 times/day on Day 1-7 and once on Day 8. Possible range of outcomes for TSS: 0 - 660 (higher numbers indicating worse outcomes)
2 secondary outcomes
Area Under Curve of Symptom Scores
Time frame: 8 days
Incidence(s) of Laboratory Confirmed Illness
Time frame: 8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyrus Ghobadi, MD principal investigator
hVIVO Services Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PrEP-001 in people with Viral Upper Respiratory Tract Infection, run by Prep Biopharm Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Symptom Scores (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.