Flu vaccination MedDRA version: 20.0 Level: LLT Classification code 10016794 Term: Flu vaccination System Organ Class: 100000004865
Conditions
Interventions
Product Name: Multimeric-001
Product Code: M-001
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: N/A
Current Sponsor code: M-001
Other descriptive name: MULTIMERIC-001
Concentratio
Sponsors
BiondVax Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible to participate in this study must meet all of the following inclusion criteria: 1. Male and female subjects 50 years of age (inclusive) or older, willing and able to give the written informed consent prior to study entry. 2. Able to comply with the trial procedures and be available for all study visits including answering phone calls and coming to the site as defined by the Protocol. 3. Medically stable (subjects may have underlying systemic chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled; if they are on systemic pharmacological treatment for such condition, the treatment must have been stable for at least 3 months preceding first vaccination). 4. Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice adequate effective contraception - barrier or hormone-based methods or intra uterine device (IUD) for women and a condom for males -whose female partner has childbearing potential - throughout the study treatment and for at least up to day 81 (for females) and day 111 (for males) of the trial (i.e. 60 (for females) and 90 (for males) days after the last dose of the IMP). In addition, women of childbearing potential must have practiced the contraception for a minimum of 30 days prior to study product exposure. 5. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to both study vaccinations. 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 6000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6000
Exclusion criteria
Exclusion criteria: Subjects eligible to participate in this study must not meet any of the following exclusion criteria: 1. History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine. 2. Known or suspected (or have a high risk of developing) significant impairment/alteration of immune function (excluding that normally associated with advanced age - as judged by PI/SI 3. Receipt of: a) Current (including within 60 days or planned during the study) daily use of immunosuppressive drugs: i) systemic glucocorticoids = 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 6 months before the study or planned during the study e) Other vaccines within 30 days before, or planned during, the study. 4. Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, or congestive heart failure, as judged by the PI/SI. 5. An acute illness, which occurred within 1 week before first vaccination, as judged by the PI/SI, or body temperature greater than: for participants age 50-59 37.9ºC (axillary or forehead) or 38.4 ºC (oral), or 38.9ºC (ear/tympanic or rectal); for participants of age 60 or more, greater than 37.2ºC (axillary or forehead) or 37.7 ºC (oral), or 38.2ºC (ear/tympanic or rectal), which occurred within 1 week before first vaccination. 6. Anatomical deficiencies which exclude possibility of taking NP swab or throat and nasal swab. 7. Women who are breastfeeding or planning pregnancy during the period of the study Institutionalized subjects or subjects unable to come to the study site as expected by the Protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Safety: To assess M-001 Safety by solicited local and systemic reactogenicity events occurring within 8 days (day of the vaccination inclusive) following receipt of each of the two doses of M-001 or placebo and to assess SAEs, and new-onset of chronic medical illnesses (NOCIs) during period from Day 0 until end of first passive surveillance period in each group. To assess M-001 Safety by occurrence of unsolicited AEs from the time of first study vaccination through 22 days after each M-001 vaccination (day of the vaccination inclusive). Clinical Efficacy: Compare the occurrence of either qRT-PCR or culture confirmed influenza in the M-001 experimental group vs. placebo (= 15 days after the second vaccination until epidemiological levels of influenza are low as defined by the medical director) caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness (ILI is defined as symptoms that include one of the following respiratory symptoms (sore throat, cough, sputum production, nasal discharge or congestion, wheezing or difficult breathing) and at least one additional systemic symptom [fever (oral temperature >37.2°C for age 50-59, or >36.7°C for age 60 or more, or increased = 1.3°C from baseline), headache, myalgia and/or arthralgia, chills, and fatigue (tiredness for at least 12 hours)]. NP (Nasopharyngeal) or combined nasal and throat swab will be collected from participants who meet the ILI definition for qRT-PCR analysis of influenza A and/or B virus. Influenza positive samples by PCR will be further analysed for culture confirmation;Main Objective: Safety: To assess M-001 Safety by solicited local and systemic reactogenicity events occurring within 8 days (day of the vaccination inclusive) following receipt of each of the two doses of M-001 or placebo and to assess SAEs and new-onset of chronic medical illnesses (NOCIs) during period from Day 0 until end of first passive surveillance period in each group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: June 2020;Secondary end point(s): 1. Compare the occurrence of culture confirmed influenza in the M-001 experimental group vs. placebo (= 15 days after the second vaccination until epidemiological levels of influenza are low as defined by the medical director) caused by any influenza A or B virus in association with a protocol defined ILI. Nasopharyngeal swab will be collected from participants who meet the ILI definition within 24 hours from ILI being reported to or identified by study personnel for qRT-PCR confirmation of influenza A and/or B virus (a nasal and throat sample can be collected as alternative method), and the samples identified with qRT-PCR as positive for influenza A or B virus will be verified with virus culture. 2. Reduced Severity of influenza illness Reduction of either qRT-PCR or Culture-confirmed influenza illness severity; The timereduction due to lM-001 in the average number of days with respiratory or systemic symptoms during the first laboratory-confirmed influenza illness episode 3. The percentage of subjects having ILI symptoms in the experimental and control group 4. The change from baseline in the percentage of CD4+ lymphocytes producing Th1 cytokine (e.g. INF-?) in response to any of the 9 peptides in M-001. This endpoint will be assessed within a randomly selected subset of participants from pre-selected sites participating to the substudy in Year 2. | — |
Countries
Bulgaria, Croatia, Georgia, Hungary, Latvia, Poland, Ukraine
Contacts
Public ContactTamar Ben-Yedidia
BiondVax Pharmaceuticals Ltd.
Outcome results
None listed