MedDRA version: 14.1 Level: LLT Classification code 10022002 Term: Influenza A virus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Vaccine FP-01.1
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: Fluoropeptide FA-P44
Current Sponsor code: FA-P44
Concentration unit: mg/ml milligram(s)
Sponsors
Immune Targeting Systems Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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) 90 mmHg, a systolic BP 150 mmHg, a pulse 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterise the safety and tolerability profile of Vaccine FP-01.1.;Secondary Objective: Efficacy To compare the incidence, severity and duration of signs and symptoms of influenza-like illness after virus challenge between subjects pre-vaccinated with Vaccine FP-01.1 and subjects pre-vaccinated with placebo. Pharmacodynamics To compare the incidence, magnitude and duration of viral shedding after virus challenge between subjects pre-vaccinated with Vaccine FP-01.1 and subjects pre-vaccinated with placebo. Immunogenicity -To further characterise the immunological response (both humoral and CMI) to vaccination by Vaccine FP-01.1; -To explore the relationship between the immunological response to vaccination and the clinical and pharmacodynamic response to challenge. Safety To further characterise the safety and tolerability profile of Vaccine FP-01.1. Exploratory Objective Exploratory analysis of host gene expression using microarray technology. Any results from this analysis will be reported separately from the clinical study report. ;Primary end point(s): Primary endpoints of safety and tolerability will be monitored throughout the study by assessment of AEs, concomitant medications, clinical laboratory safety tests (serum biochemistry and haematology), physical examinations, vital signs (blood pressure, pulse rate, respiratory rate), 12-lead ECGs, spirometry and local injection site reactions;Timepoint(s) of evaluation of this end point: Adverse events and monitoring of concomitant medications will be conducted throughout the trial, from screening through to the last visit. Clinical laboratory safety tests (which include serum biochemistry and haematology) will be conducted at visits 2 (days -28 to -2), 3 (day 1), 5 (day 8), 6 (day29±1), 8 (day 36), 9 (days 43±1 – 52, virus challenge quarantine period) and visit 10 (day 57±1[non-challenge] or 72±1[challenge]). Physical examinations and vital signs tests will be conducted at visits 2, 3, 6, 9 a | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Viral shedding tests for Efficacy will be conducted throughout the quarantine period (visit 9). Subject symptom scoring and oral temperature tests will be conducted during visit 9. Blood samples for T cell and HI assays, serum and cellular immunoanalysis will be conducted at one or more of the panel screening and visits 2, 3, 5, 8, 9 and 10. Optional blood samples will be taken from subjects providing consent for exploratory genomic analysis at visits 3 (day 1), 7 (day 30) and 9. ;Secondary end point(s): Efficacy evaluations following viral challenge will be based on the incidence of laboratory confirmed illness (viral shedding) and the signs and symptoms of influenza (targeted physical examinations, oral temperature and subject symptom scores). Pharmacodynamic evaluations will be based on the magnitude and duration of viral shedding and immunogenicity evaluations will be based on the T cell (PBMC assay) and antibody immunological response to vaccination (HI assays). Exploratory investigation into the changes in gene expression following vaccination and/or challenge will be based on microarray studies. | — |
Countries
United Kingdom
Contacts
Public ContactJeanette Watson
Immune Targeting Systems Ltd
Outcome results
None listed