vaccine against influenza MedDRA version: 18.1 Level: LLT Classification code 10016794 Term: Flu vaccination System Organ Class: 100000004865
Conditions
Interventions
Product Name: Multimeric-001 1 mg
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 influ
Sponsors
BiondVax Pharmaceuticals ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Healthy male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 60 years, inclusive; -Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice adequate contraception (a combination of barrier and hormone methods for women and a condom for men) throughout the study treatment and for at least up to day 51 (for female) and day 111 (for male) of the trial (i.e. 30 (for female) and 90 (for male) days after the last dose of the IMP) -Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), blood chemistry test (electrolytes, renal/kidney function, liver function, C-reactive protein, complete blood count), medical history, general physical examination, self-reported illness and clinical judgment of the investigator -Able to understand and comply with planned study procedures -Provides signed informed consent form after receiving a detailed explanation of the study protocol prior to any study procedures. 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 222 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Has a known allergy to components of the vaccine (e.g. egg products) -Has a history of severe reactions following immunization with contemporary influenza virus vaccines -Persons with immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy -Has a positive urine pregnancy test prior to vaccination or women who are breastfeeding -Has a history of any of the following (reported by subjects): Acute disseminated encephalomyelitis (ADEM); Active neoplastic disease; Asthma or severe allergic disease; Bleeding disorders Chronic Hepatitis B and/or C infection; Chronic liver disease; Diabetes mellitus; Guillain-Barré syndrome; HIV; Rheumatoid arthritis or other autoimmune diseases; Severe renal disease; Transplant recipients; Unstable or progressive neurological disorders. Receipt of medicines/treatments that may affect evaluation of immunogenicity such as: Oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs; Immunoglobulin or other blood products (within the 3 months prior to vaccination in this study); Experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expects to receive an experimental agent (during the 18-month study period). Influenza antiviral medication (within the 4 weeks prior to vaccination in this study). -Has received any influenza vaccine within 6 months prior to vaccination in this study. -Has influenza-like illness within 6 months prior to vaccination in this study. -Has an acute illness, including an oral temperature greater than 38 degrees oC, within 1 week before vaccination -Has a history of alcohol or drug abuse -Any abnormal hematology values and/or serum chemistries judged by the Investigator as clinically significant -Ineligible subject based on the judgement of the investigator -In case there is uncertainty about the participant’s medical status regarding any of the exclusion criteria mentioned, the participant’s primary care physician will be consulted. Consultation of the primary care physician will only take place after having received written approval from the participant, and will concern medical information about exclusion criteria only
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the immunogenicity and safety of M-001 in a prime-boost strategy with H5N1 vaccination in healthy adults.;Secondary Objective: To evaluate the humoral immune responses (serum hemagglutination inhibition (HAI) titer) in all groups 0 and 63 days following M-001 and H5N1 vaccination in all subjects towards the H5N1 vaccine strain.;Primary end point(s): For immunogenicity: To evaluate the cellular immune responses based on multiparametric FACS analysis in all groups at 0 and 42 days following M-001 vaccination, in all subjects. For safety: (1) To evaluate the solicited AEs in all subjects until 21 days after the last dosing of the study vaccine (M-001); (2) To evaluate the unsolicited AEs and SAEs in all subjects for 180 days after the first dosing of M-001.;Timepoint(s) of evaluation of this end point: 180 days after the first dosing of M-001 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the humoral immune responses (serum hemagglutination inhibition (HAI) titer) in all groups at 0 and 63 days following M-001 and H5N1 vaccination in all subjects towards the H5N1 study vaccine strain.;Timepoint(s) of evaluation of this end point: days 0 and 63 | — |
Countries
Hungary
Contacts
Public Contactlocal representative in Hungary
SanaClis s.r.o.
Outcome results
None listed