NCT02104869

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

April 2, 2014

Last Update Submit

July 20, 2015

Conditions

Human Influenza

Keywords

Influenza vaccine

Outcome Measures

Primary Outcomes (3)

  • Percentage of Seroconversion.

    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.

    21 days (+7 days) after vaccination.

  • Percentage of Seroprotection

    Seroprotection will be defined as post-vaccinations HI titers ≥1:40.

    21 days (+7 days) after vaccination.

  • Increase in the geometric mean titers of HI post-vaccination.

    21 days (+7 days) after vaccination.

Secondary Outcomes (1)

  • Solicited and unsolicited local and systemic adverse reactions.

    Until day 3 post-vaccination.

Study Arms (4)

Recommended dose (kidney transplant)

ACTIVE COMPARATOR

Intervention: trivalent influenza vaccine (inactivated and fragmented). Dosage form: each 0.5 mL dose of the vaccine contains Myxovirus influenzae strains propagated in embryonated chicken eggs, equivalent to: A/California/7/2009 (H1N1) pdm09 (15 mcg of hemagglutinin); A/Texas/50/2012 (H3N2) (15 mcg of hemagglutinin); B/Massachusetts/2/2012 (15 mcg of hemagglutinin); Thimerosal (2 mcg). Dose: single 0.5 mL dose.

Biological: Trivalent influenza vaccine (inactivated and fragmented).

Healthy adults

ACTIVE COMPARATOR

Intervention: trivalent influenza vaccine (inactivated and fragmented). Dosage form: each 0.5 mL dose of the vaccine contains Myxovirus influenzae strains propagated in embryonated chicken eggs, equivalent to: A/California/7/2009 (H1N1) pdm09 (15 mcg of hemagglutinin); A/Texas/50/2012 (H3N2) (15 mcg of hemagglutinin); B/Massachusetts/2/2012 (15 mcg of hemagglutinin); Thimerosal (2 mcg). Dose: single 0.5 mL dose.

Biological: Trivalent influenza vaccine (inactivated and fragmented).

Single double dose (kidney transplant)

EXPERIMENTAL

Intervention: trivalent influenza vaccine (inactivated and fragmented). Dosage form: each 0.5 mL dose of the vaccine contains Myxovirus influenzae strains propagated in embryonated chicken eggs, equivalent to: A/California/7/2009 (H1N1) pdm09 (15 mcg of hemagglutinin); A/Texas/50/2012 (H3N2) (15 mcg of hemagglutinin); B/Massachusetts/2/2012 (15 mcg of hemagglutinin); Thimerosal (2 mcg). Dose: single 1.0 mL dose.

Biological: Trivalent influenza vaccine (inactivated and fragmented).

Two sequential doses (kidney transplant)

EXPERIMENTAL

Intervention: trivalent influenza vaccine (inactivated and fragmented). Dosage form: each 0.5 mL dose of the vaccine contains Myxovirus influenzae strains propagated in embryonated chicken eggs, equivalent to: A/California/7/2009 (H1N1) pdm09 (15 mcg of hemagglutinin); A/Texas/50/2012 (H3N2) (15 mcg of hemagglutinin); B/Massachusetts/2/2012 (15 mcg of hemagglutinin); Thimerosal (2 mcg). Dose: two 0.5 mL doses 21 days apart.

Biological: Trivalent influenza vaccine (inactivated and fragmented).

Interventions

Trivalent influenza vaccine (inactivated and fragmented).BIOLOGICAL
Healthy adultsRecommended dose (kidney transplant)Single double dose (kidney transplant)Two sequential doses (kidney transplant)

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Kidney transplant for more than 30 days;
  • 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.

You may not qualify if:

  • 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;
  • 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;
  • 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
  • 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.
  • 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;
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Divisão de Clínica Urológica e Divisão de Moléstias Infecciosas

São Paulo, São Paulo, 05403-010, Brazil

Location

Related Publications (1)

  • Odongo FCA, Braga PE, Palacios R, Miraglia JL, Sartori AMC, Ibrahim KY, Lopes MH, Caiaffa-Filho HH, Timenetsky MDCST, Agena F, Fonseca de Azevedo LS, David-Neto E, Precioso AR, Pierrotti LC. An Open-label Randomized Controlled Parallel-group Pilot Study Comparing the Immunogenicity of a Standard-, Double-, and Booster-dose Regimens of the 2014 Seasonal Trivalent Inactivated Influenza Vaccine in Kidney Transplant Recipients. Transplantation. 2022 Jan 1;106(1):210-220. doi: 10.1097/TP.0000000000003702.

    PMID: 33988337DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Alexander R Precioso, MD, PhD

    Instituto Butantan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 4, 2014

Study Start

April 1, 2014

Primary Completion

August 1, 2014

Study Completion

March 1, 2015

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

BR(1)