Human InfluenzaPhase 4NCT02104869
Clinical Trial for the Evaluation of Three Regimens of Influenza Vaccination in Kidney Transplant Recipients
A Phase 4 study testing Trivalent influenza vaccine (inactivated and fragmented). in people with Human Influenza, run by Butantan Institute at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Influenza
- What is being tested?
- Trivalent influenza vaccine (inactivated and fragmented).
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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;
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- 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
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
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
About this study
Official title: 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
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.
Read more
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).
- Conditions
- Human Influenza
- Being tested
- Trivalent influenza vaccine (inactivated and fragmented).
- Keywords
- Influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent influenza vaccine (inactivated and fragmented).Biological
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: Trivalent influenza vaccine (inactivated and fragmented). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days (+7 days) after vaccination.
Percentage of Seroprotection
Seroprotection will be defined as post-vaccinations HI titers ≥1:40.
Measured: 21 days (+7 days) after vaccination.
Increase in the geometric mean titers of HI post-vaccination.
Measured: 21 days (+7 days) after vaccination.
Secondary outcomes (1)
Solicited and unsolicited local and systemic adverse reactions.
Measured: Until day 3 post-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Alexander R Precioso, MD, PhD, Study director, Instituto Butantan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104869
- Sponsor's protocol ID
- FLU-03-IB
- Other IDs
- U1111-1155-2836
- Status last verified
- Jul 2015
- First submitted
- 2 Apr 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33988337
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02104869
- Acronym / sponsor ID
- FLU-03-IB
- Conditions
- Human Influenza
- Keywords
- Influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Recommended dose (kidney transplant) | Active comparator | Biological: Trivalent influenza vaccine (inactivated and fragmented).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. |
| Healthy adults | Active comparator | Biological: Trivalent influenza vaccine (inactivated and fragmented).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. |
| Single double dose (kidney transplant) | Experimental | Biological: Trivalent influenza vaccine (inactivated and fragmented).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. |
| Two sequential doses (kidney transplant) | Experimental | Biological: Trivalent influenza vaccine (inactivated and fragmented).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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (27 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trivalent influenza vaccine (inactivated and fragmented). | Biological | Healthy adults, Recommended dose (kidney transplant), Single double dose (kidney transplant), Two sequential doses (kidney transplant) |
Primary outcome
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.
1 secondary outcome
Solicited and unsolicited local and systemic adverse reactions.
Time frame: Until day 3 post-vaccination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
- Derived from this study: PubMed 33988337Odongo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander R Precioso, MD, PhD study director
Instituto Butantan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trivalent influenza vaccine (inactivated and fragmented). in people with Human Influenza, run by Butantan Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Seroconversion. (time frame: 21 days (+7 days) after vaccination.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02104869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.