Influenza virus MedDRA version: 19.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Influenza virus vaccine
Product Code: FLU-v
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: FLU-5
Sponsors
PepTcell Limited (trade name SEEK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy males and females aged =18 and =55 years of age at the point of enrolment. 2) Willingness to remain in isolation for the duration of viral shedding and to 3) comply with all study requirements. The following criteria are applicable to subjects in a heterosexual relationship and female subjects in a same sex relationship (i.e., the criteria do not apply to male subjects in a 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 - Two forms of effective contraceptive methods among (between) the couple, which are defined as: For males: 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: § 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 females participating in the study). § If of childbearing potential, then acceptable forms of contraception include: § Established (a minimum of 2 weeks prior to admission) 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: § Males: ·Comply with agreed contraception at entry to quarantine, and continuing until 90 days after the date of viral challenge/last dosing with IMP (whichever occurs last). · Must not donate sperm following discharge from quarantine until 90 days after the date of viral challenge/last dosing with IMP (whichever occurs last). § Females: If of childbearing potential must have a negative pregnancy test at screening and just prior to the date of Viral Challenge, and must be using contraception consisting of two forms of birth control (one of which must be a barrier method) starting from at least 2 weeks prior to entry to quarantine and continuing until 90 days after the date of Viral Challenge/last dosing with IMP (whichever occurs last). 4) Willing to have samples stored for future research. 5) Sero-suitable to the study challenge virus within 90 days of Day 0. 6) Agrees to abstain from alcohol intake 24 hours before admission on Day -2 and all other outpatient visits. 7) Agrees to not use prescription or over-the-counter medications (including aspirin, decongestants, antihistamines, and other NSAIDs), and herbal medication (including, but not limited to, Vitamin C, Vitamin D, immune booster products, herbal tea, St. John’s Wort), within 14 days prior to study vaccine administration through the final follow-up visit, unless approved by the inves
Exclusion criteria
Exclusion criteria: 1) For information on smoking and how it affects participation in the trial, please see Protocol Section 7.3 – Exclusion Criteria 2) Presence of self-reported or medically documented significant medical condition. For more detailed information, please see Protocol Section 7.3 - Exclusion Criteria 3) Individual with body mass index (BMI) =18 and =35. 4) Acute illness within 7 days of first vaccine administration day. 5) Clinically significant abnormal electrocardiogram (ECG) and/or parameters, as determined by the Investigator 6) Subjects with clinically significant abnormal systolic and diastolic blood pressure or clinically significant abnormal pulse rate. 7) Subject has abnormal pulmonary function as measured by spirometry defined as a forced vital capacity or forced expiratory volume in 1 second (FEV1) < 80% of predicted or peripheral arterial oxygen saturation (SpO2) < 92% on room air. 8) Known allergy to treatments for influenza (including but not limited to oseltamivir, nonsteroidals). 9) For more information on participant allergies and how they might affect their participation, please see Protocol Section 7.3 - Exclusion Criteria. 10) Daily or household contact with vulnerable populations as defined by 5.2.4.1 11) (a) Receipt of any investigational drug within 3 months prior to the planned date of Viral Challenge/first dosing with IMP (whichever occurs first) (b) Receipt of three or more investigational drugs within the previous 12 months prior to the planned date of Viral Challenge/first dosing with IMP (whichever occurs first). (c) Prior inoculation with a virus from the same virus-family as the Challenge Virus. (d) Prior participation in another Human Viral Challenge study with a respiratory virus in the preceding 12 months taken from the date of Viral Challenge/first dosing with IMP (whichever occurs first) in the previous study to the date of expected Viral Challenge in this study. 12) Receipt of any vaccine within 6 months of enrolment. 13) Self-reported or known history of alcoholism or drug abuse (including marijuana) within 6 months prior to enrolment, or positive urine/serum test for drugs of abuse during the study. 14) Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI to be a contraindication to protocol participation. 15) History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis. 16) Any condition or event that, in the judgment of the PI, is a contraindication to protocol participation or impairs the volunteer’s ability to give informed consent. 17) History or evidence of autoimmune disease or known immunodeficiency of any cause – with the exception of atopic dermatitis/eczema and atopic rhinitis. 18) Subjects with any history of physician diagnosed and/or objective test confirmed asthma (except as per inclusion criteria 10, reactive airway disease, COPD, pulmonary hypertension, or chronic lung condition of any aetiology. 19) Positive human immunodeficiency virus (HIV) within 60 days of first vaccination visit, active hepatitis A (HAV), B (HBV), or C (HCV) test. 20) Any sig
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of FLU-v on reducing the incidence of Mild to Moderate Influenza Disease (MMID) defined as detectable viral shedding plus at least one symptom of influenza ;Secondary Objective: To determine the overall effect of FLU-v on measurements of disease severity;Primary end point(s): Incidence of Mild to Moderate Influenza Disease ;Timepoint(s) of evaluation of this end point: upto Day 35 (+/- 3 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Viral shedding duration • Viral shedding quantitation • Symptom duration • Total number of symptoms experienced • Symptom severity score as measured by FLU-PRO • Incidence of vaccine related adverse events (diary card for 21 days after each vaccine) ;Timepoint(s) of evaluation of this end point: up to day 35 (+/- 3 days) | — |
Countries
United Kingdom
Contacts
Public ContactClinical trials information
PepTcell Limited (trading as SEEK)
Outcome results
None listed