Influenza A/Perth/16/2009(H3N2) Virus challenge study of PrEP-001 in Healthy Volunteers

Phase 1

Conditions: Influenza A/Perth/16/2009(H3N2) Virus
MedDRA version: 18.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2015-002895-26-GB

Lead Sponsor: hVIVO Services Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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 documented medical history for a minimum of the last 2 years prior to entry into the study.
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 in a heterosexual relationship (i.e., the criteria do not apply to those 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).
Female study subjects who are not heterosexually active must have periodic confirmation of continued abstinence from heterosexual intercourse
Or
-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 who are not of child bearing potential i.e., women who are (post-menopausal [having a history of amenorrhea for at least 2 years], or have documented status as being surgically sterile,[have had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation, as confirmed by the General Practitioner (GP), or are otherwise incapable of becoming pregnant], must use a condom when having heterosexual intercourse from screening until 90 days after receiving the study drug. (The latter applies only to females participating in the study).
ii.If of childbearing potential, 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:
i.Male subjects must comply with agreed contraception at entry to quarantine, and continuing until 90 days after the date of Viral Challenge.
ii.Male subjects must not donate sperm following discharge from quarantine until 90 days after the date of Viral Challenge
iii.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 from14 days prior to entry to quarantine and continuing until 90 days after the date of Viral Challenge.
An informed consent document signed and dated by the subject and the Investigator.
Sero-suitab

Exclusion Criteria

1.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]
2.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.
3.Any history or evidence of any clinically significant cardiovascular, dermatological (including psoriasis), gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease that, in the opinion of the Investigator, may interfere with a subject completing the study.
4.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 (FEV1 and FVC).
5. History or evidence of autoimmune disease or known immunodeficiency of any cause – with the exception of atopic eczema/atopic dermatitis as described in exclusion criteria number (3).
6. Subjects with any history of COPD, pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology (see inclusion criteria number [8] for asthma).
7.Positive human immunodeficiency virus (HIV), active hepatitis A (HAV), B (HBV), or C (HCV) test.
8. Any significant abnormality altering the anatomy of the nose or nasopharynx.
9. Any clinically significant history of epistaxis (nosebleeds) within the last 12 months and/or History of being hospitalized due to epistaxis on any previous occasion.
10. Any nasal or sinus surgery within 6 months of Viral Challenge.
11.Recurrent history of fainting.
12.Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the Investigator, where available using information from a central reader.
13.Confirmed positive test for drugs of abuse deemed by the Investigator to be clinically significant
14.Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
15.Any clinically significant allergies such as allergy to the excipients in the Challenge Virus inoculum, PrEP-001 (cohort B only) or Placebo formulations (Cohort B only) as stipulated in the protocol.
16. Evidence of vaccinations within the 4 weeks prior to the planned date of first dosing with IMP or intention to receive any vaccination(s) before the last day of Follow-up. (NB. No travel restrictions will apply after the Day 28 Follow-up visit).
17. Those employed or immediate relatives of those employed at hVIVO
18. 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 or planned during the 3 months after the final visit.
19. 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.
20. Receipt of any investigational drug within 3 months prior to the planned date of first dosing with IMP. 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