Healthy Volunteers - a quadrivalent inactivated split virus influenza vaccine MedDRA version: 19.1 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 100000004865
Conditions
Interventions
Trade Name: a-RIX-Tetra
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: A/CALIFORNIA/7/2009 (H1N1) PDM09-LIKE STRAIN USED (NIB-74XP) DERIVED FROM A/CHRISTCHURC
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects aged 24-54 years inclusive. (Healthy in the opinion of the investigator, based on medical history and clinical exam, with no active disease process that could interfere with the study endpoints) 2. Has a body Mass Index =18 and =30 3. Is able to read and understand the Informed Consent Form (ICF), and understand study procedures. 4. The subject has signed the ICF. 5. The subject is available for follow-up for the duration of the study. 6. The subject agrees to abstain from donating blood during their participation in the study, or longer if necessary. 7. If the subject is a heterosexually active female, she is willing to use an effective method of contraception (e.g. oral contraceptive pill; intrauterine device; injectable or implanted contraceptive; physiological or anatomical sterility) from 30 days prior to study vaccination until the end of the study. 8. Willing to undergo urine pregnancy tests prior to vaccination at screening. 9. The subject has venous access sufficient to allow blood sampling as per 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 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating. 2. Known hypersensitivity to any component of the study vaccine (a-RIX-Tetra®): the active components (vaccine antigens) or any of the excipients (disodium phosphate dodecahydrate, potassium dihydrogen phosphate, magnesium chloride hexahydrate, a-tocopheryl hydrogen succinate, polysorbate 80, octoxinol 10), eggs (chicken proteins, ovalbumin), gentamycin sulphate, formaldehyde, and sodium deoxycholate or those who have had a previous life-threatening reaction to previous influenza vaccinations. 3. History of influenza infection in the past 5 years, defined here as severe respiratory infection with fever (> 38°C) and preventing normal daily activity during a minimum of 3 days. 4. Vaccination with the 2016/2017 seasonal influenza vaccine and/or any other seasonal influenza vaccine within the preceding 5 influenza seasons (i.e. since season 2011/2012) before the first study visit. 5. Presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including use of oral or parenteral corticosteroids in a dose = 5 mg prednisone daily or equivalent within one month prior to visit 1or cytotoxic or immunosuppressive or immunomodulating drugs within 6 months prior to visit 1). 6. Regular use of non-steroidal anti-inflammatory drugs (oral or parenteral route) within 6 months of Visit 1 considered by the study physician as likely to interfere with immune responses. 7. Current intake of excessive amounts of alcohol (= 14 units for women and = 21 units for men) and not willing to adapt this use during the study period. 8. Currently performing extreme physical activities (as evaluated by the investigator) and not willing to adapt this activity during the study period. 9. Receipt of a vaccine within 30 days of visit 1, or requirement to receive another vaccine within the study period. 10. Presence of an acute severe febrile illness at time of immunisation. 11. History of alcohol, narcotic, benzodiazepine, rilatine, or other substance abuse or dependence within the 12 months preceding Visit 1. 12. Smoking in the past 6 months OR > 5 pack-year lifetime history 13. Receipt of blood products or immunoglobulins, or blood donation, within 3 months of study start. 14. Any condition that, in the investigator’s opinion, compromises the subject’s ability to meet protocol requirements or to complete the study. 15. Currently participating in another clinical study with an investigational or non-investigational drug or device, or has participated in a clinical trial within the 3 months preceding Visit 1. 16. Unable to read and speak Dutch or English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. The dataset will broadly characterise: : 1. Physiological responses at various time points after immunisation 2. Innate and adaptive immune responses 3. Genetic testing of subjects when deemed necessary (genetic testing analysis may be SNIP analysis or full genome analysis). 4. Correlations in changes in innate and adaptive immune activation with adverse events, haematology and biochemistry panels, genotype and physiological assessments;Secondary Objective: none;Primary end point(s): 1. Frequency and severity of local and systemic vaccine-related clinical events. 2. Change from pre-immunisation baseline values in pulse, temperature, blood pressure. 3. Change from pre-immunisation baseline values in haematology (CBC, ESR, phenotyping of WBC), biochemistry parameters. 4. Change from pre-immunisation baseline values in global gene expression measured on whole blood samples 5. Change from pre-immunisation baseline values in serum HAI titre in serum samples 6. Change from pre-immunisation values of adaptive cellular immune response will be evaluated. 7. Change from pre-immunisation baseline values in concentration of selected cytokines and acute phase proteins in serum samples 8. Change from pre-immunisation baseline values in PBMC cytokine secretion, proliferation or surface markers in response to in vitro stimulation with influenza antigens;Timepoint(s) of evaluation of this end point: 1. at all time points from vaccination up to last study visit. 2. at all time points from time of immunisation up to last study visit. 3. at selected time points from time of immunisation up to last study visit. 4. at selected time points from time of immunisation up to last study visit 5. at selected time points from time of immunisation up to last study visit 6. at selected time poin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed