Clinical Trial for the Evaluation of Three Regimens of Influenza Vaccination in Kidney Transplant Recipients

Kidney Transplant Recipients

Inclusion criteria

• Kidney transplant for more than 30 days;
• 18 to 59 years of age;
• Functioning graft (patients without an indication for dialysis at the time, regardless of the glomerular filtration rate);
• Ability to understand and engage with all procedures required for participation in the study;
• Willingness to participate documented by the signature of the ICF.

Exclusion criteria

• Double transplant (other organ besides the kidney);
• Graft loss;
• HIV infection or malignancy;
• Known systemic hypersensitivity to any component of the vaccine, thimerosal, neomycin, formaldehyde, Triton X-100 (octoxynol 9), egg or chicken protein, any drug or substance which contain the same components of the vaccine or after previous administration of this product;
• Any acute condition and/or fever within 7 days prior to vaccination or axillary temperature greater than 37,8°C on the day of vaccination;
• Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 21 days after inclusion in the study;
• Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;
• Use of any investigational product within 42 days prior to the inclusion in the study (visit V0) or scheduled to receive it after the inclusion in the study (visit V0);
• Inclusion in another clinical trial six months prior to vaccination;
• Denies permission for biological material storage for future research as defined in ICF;
• Any other condition that, in the investigator's opinion or of his representative, might put at risk the safety/rights of a potential participant or could hamper his/her compliance with the protocol.

Healthy Adults

Inclusion criteria

• Healthy adults of both sexes with 18 to 59 years of age;
• Be available to participate during the entire study period;
• Demonstrate intent to participate in the study, documented by signing the IC.

Exclusion criteria

• Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as clinical history, physical examination and/or laboratory results;
• Compromised immune system diseases including: diabetes mellitus, cancer (except basal cell carcinoma) and autoimmune diseases;
• Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;
• Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history;
• Known systemic hypersensitivity to any component of the vaccine, thimerosal, neomycin, formaldehyde, Triton X-100 (octoxynol 9), egg or chicken protein, any drug or substance which contain the same components of the vaccine or after previous administration of this product;
• Diagnosis of asthma with a history of hospitalization in the last six months due to illness;
• Any acute illness and/or fever in the 7 days prior to study inclusion or axillary temperature greater than 37.8 ° C on the day of vaccination (visit V0);
• Use of corticosteroids (except topical or nasal) or other immunosuppressive drugs within 42 days before study initiation/baseline. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose ≥10 mg of prednisone per day for over 14 days;
• Use of anticoagulant medication;
• Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 42 days after receiving the investigational product;
• History of asplenia;
• Have received blood products in the past six months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the first 42 days after vaccination; -Use of any investigational product within 42 days before or after receiving this - study vaccination;
• Has participated in another clinical trial six months prior to vaccination;
• Denies permission for biological material storage for future research as defined in ICF;
• Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator's opinion or his representative physician.