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Sponsor: Assistance Publique - Hôpitaux de Paris
Conditions: Morbid Obesity, Severe Obesity
Interventions: Supemtek®, Vaxigriptetra®
Countries: France
Obesity has been considered as a risk factor for mortality and development of complications during infection with the influenza virus. Several case studies of severe and fatal infections have identified possible effects of obesity on disease progression; these effects include extensive viral replication in the deep lung, progression to viral pneumonia, and prolonged and increased viral shedding. These points may be linked to obesity which causes a chronic state of meta-inflammation with systemic implications for immunity: obese patients exhibit delayed and blunted innate and adaptive immune responses to influenza virus infection, and they experience poor recovery from the disease leading to an increased susceptibility to secondary bacterial infections and poor healing of the lung epithelium. Furthermore, in obese people, influenza virus may exploit the lack of antiviral pressure, generate a more virulent population and increase disease severity Due to the growing prevalence of obesity worldwide (500 million subjects in 2017), it is important to be able to offer vaccines that provide the highest protection for this at-risk population. The quadrivalent recombinant high-dose influenza vaccine has been shown to have greater immunogenicity and efficacy than standard influenza vaccine in non-obese adults older than 50 years. However, this vaccine has never been evaluated in obese subjects. Investigators thus planned this trial to assess whether the use of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) will induce a better immunological answer than current quadrivalent standard vaccine (SD) in patients with severe obesity, with an acceptable safety profile, thus leading to a better protection against influenza in this population at high risk of influenza complications.
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria:
1. ≥18 and ≤75 years old
2. Body Mass Index (BMI) ≥35 kg/m2
3. No previous vaccination against influenza (in the preceding 6 months) with either the trial vaccine or another vaccine
4. Absence of health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 15 days prior to enrolment.
5. Signed informed consent
6. Participants covered by social security regimen .
Exclusion Criteria:
1. Known active infection with HIV and / or HBV (HBs antigen) and / or HCV (RNA positive viral load)
2. Immunodepression or diagnosis of having congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory, bowel disease, or other autoimmune condition
3. Known acute evolving neurological disorder or history of Guillain-Barré syndrome.
4. Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (tympanic temperature ≥38°C on the day of vaccination). A subject should not be included in the trial until the condition has resolved or the febrile event has subsided.
5. Proven Influenza infection in the 6 months preceding the study
6. Known systemic hypersensitivity to any of the vaccine components, including a documented allergy to egg proteins, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
7. Receipt of any vaccine in the 2 weeks (14 days) preceding the trial vaccination
8. History of bariatric surgery in the 2 years preceding the study.
9. Bariatric surgery planned during the study period.
10. Receipt of immune globulins, blood or blood-derived products in the 3 months preceding the study or planned during the study period.
11. Taking immunosuppressive treatment (including chemotherapy, oral corticosteroids with doses ≥10 mg/day of prednisone or equivalent during ≥15 days) or radiotherapy in the 6 months preceding the study or planned during the study.
12. Contraindication to intramuscular injection
13. Female subjects of childbearing potential :
* without an adequate contraception (see chapter 5.8) for 30 days prior to vaccination within the context of the study,
* breastfeeding
* with a positive pregnancy test on the day of vaccination,
* did not agreed to continue adequate contraception during 2 months after completion of the vaccination.
14. Participation at the time of trial enrollment (or in the 4 weeks \[28 days\] preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
15. Anticipated inability to follow the protocol requirements (e.g. comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits). 16. Participants covered by AME.- Paris, France