Open Label Parallel Randomized Clinical Trial to Evaluate the Immunogenicity of Three Regimens of the Trivalent Influenza Vaccine (Inactivated and Fragmented) in Kidney Transplant Recipients
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Human Influenza
- Sponsor
- Butantan Institute
- Enrollment
- 195
- Locations
- 1
- Primary Endpoint
- Percentage of Seroconversion.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This will be an open label, parallel, randomized clinical trial that will evaluate the immunogenicity and safety of the trivalent influenza vaccine (inactivated and fragmented) produced by Instituto Butantan among adult kidney transplant recipients, when administered in three vaccination regimens: i) the recommended dose; ii) a single double dose; iii) two doses administered with a 21 day interval.
The randomization ratio among the three groups of kidney transplant recipients will be 1:1, and 60 participants will be included in each group. After vaccination all participants will be followed for 26 weeks.
In addition, 15 healthy adults will be included as a control group, and will receive the recommended dose.
The study hypothesis is that a different vaccination regimen can improve the immune response of kidney transplant recipients after vaccination with the trivalent influenza vaccine (inactivated and fragmented).
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Percentage of Seroconversion.
Time Frame: 21 days (+7 days) after vaccination.
Seroconversion will be defined as HI titers ≥1:40 post-vaccination among subjects with pre-vaccination HI titers \<1:10, or as a 4-fold increase in post-vaccination HI titers among subjects with pre -vaccination HI titers ≥ 1:10.
Percentage of Seroprotection
Time Frame: 21 days (+7 days) after vaccination.
Seroprotection will be defined as post-vaccinations HI titers ≥1:40.
Increase in the geometric mean titers of HI post-vaccination.
Time Frame: 21 days (+7 days) after vaccination.
Secondary Outcomes
- Solicited and unsolicited local and systemic adverse reactions.(Until day 3 post-vaccination.)