A study to assess the safety and tolerability of an influenza strain A vaccine and the efficacy and immune response following vaccination and infection with influenza virus. The study will be controlled using both the investigational vaccine and an equivalent placebo and be conducted in healthy volunteers.

Phase 1

• Conditions: MedDRA version: 14.1Level: LLTClassification code 10022002Term: Influenza A virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-004612-22-GB
• Lead Sponsor: Immune Targeting Systems Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-05
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Male or female aged 18 to 45 years inclusive, with a body mass index of 18.0 to 32.0 kg/m2 inclusive and body weight of 50.0 to 110.0 kg inclusive;
•Subjects who are able and willing to give written informed consent to participate;
•Healthy, as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical safety laboratory examinations at screening (Visit 2) and Day C-1 (prior to virus challenge), as determined by the Investigator;
•Absent or low levels of detectable pre-existing antibodies to the challenge H1N1 virus (HI titre of =10) and predicted seasonal H3N2 virus (HI titre of =40) prior to vaccination;
•Subjects who are non-smokers for at least 3 months preceding screening (Visit 2) and able to refrain from smoking until after the completion of Visit 9 [Day C29];
•Females of non-childbearing potential or female subjects of childbearing potential who are using medically acceptable methods of contraception;
•Comprehension of the study requirements, expressed availability for the required study period, and ability to be quarantined for up to 10 days and to attend the scheduled follow-up visits (Day C29 and Day 209);
•Negative alcohol and urine drug screening tests on screening (Visit 2) and prior to entering quarantine (Day C-1);
•Being willing to adhere to the prohibitions and restrictions specified in the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 138
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Receipt of any influenza vaccine after 31 August 2011;
•Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition such as chronic sinusitis;
•Abnormal nasal structure including septal deviation and nasal polyps;
•History of asthma (childhood asthma allowed), bronchiectasis, emphysema, chronic obstructive pulmonary disease or any other chronic lung disease in the last 10 years;
•Current use or use within the last 7 days from screening day (Visit 2) of intranasal corticosteroids;
•Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders;
•Subjects who do not agree to use medically acceptable methods of contraception
•Female subjects who are pregnant, trying to become pregnant or are breast feeding;
•Diastolic blood pressure (BP) <50 or >90 mmHg, a systolic BP <100 or >150 mmHg, a pulse <40 or >100 beats per minute (bpm) after resting for 5 minutes;
•FEV1 =80% of predicted FEV1;
•Blood haemoglobin A1c >6.0%;
•Positive serology for human immunodeficiency virus (HIV) 1 or HIV 2, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies;
•Cancer or treatment for cancer, within 5 years of Visit 2, excluding basal cell carcinoma of the skin, which is allowed;
•Presence of immunosuppression or any medical condition that may be associated with impaired immune responsiveness, including, but not limited to, diabetes mellitus and inflammatory bowel disease;
•Presently receiving (or history of receiving) or during the 3-month period prior to screening, any medications or other treatments that may adversely affect the immune system.
•A17.Anticipated presence of a household contact with documented severe immunosuppression (including but not limited to HIV, anyone who has haematological malignancy or is taking immunosuppressant medication), either as a result of disease and/or therapy within 2 weeks following discharge from the virus challenge quarantine period;
•Anticipated presence of a household contact age 5 years or younger, within 2 weeks following virus challenge quarantine period;
•Anticipated presence of a household contact age 65 years or older, within 2 weeks following virus challenge;
•Anticipated presence of a household contact with diagnosed emphysema, chronic obstructive pulmonary disease, severe lung disease or a lung transplant, within 2 weeks following virus challenge quarantine period;
•Current professional activity as a carer or healthcare workers who will return to work within 2 weeks following virus challenge;
•Anticipated presence of a pregnant household contact, within 2 weeks following virus challenge;
•History of anaphylactic type reaction to egg or egg protein ;
•History of Guillain-Barré syndrome;
•History of drug or chemical/alcohol abuse in the year before the study (Visit 2);
•Receipt of any investigational virus product or any IMP within 3 months prior to first vaccination, or currently enrolled in any investigational drug study or intends to enrol in such a study within the ensuing study period;
•Receipt of blood or blood products 6 months prior to first vaccination or planned administration during the study period;
•Blood donation in the 3 months prior to screening (Visit 2);
•Acute

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified