Immunogenicity and Adverse Drug Effect of Vaccines InfluenzaPhase 4NCT02105519
The Effect and Safety of the Seasonal Trivalent Influenza Vaccine in Chronic Kidney Disease Patients Not on Dialysis
A Phase 4 study testing Seasonal influenza vaccine (AdimFlu-S) in people with Immunogenicity and Adverse Drug Effect of Vaccines Influenza and Chronic Kidney Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
In recent years, several studies revealed that the current influenza vaccine strategy might be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and mortality in the end-stage renal disease population than previously thought. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunogenicity and Adverse Drug Effect of Vaccines Influenza, Chronic Kidney Disease
- What is being tested?
- Seasonal influenza vaccine (AdimFlu-S)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2013to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .Males and non-pregnant females and aged ≥ 18 years with chronic kidney disease not on dialysis;
- .Willing and able to adhere to visit schedules and all study requirements;
- .Subjects read and signed the study-specific informed consent.
- .Subjects who has either received the first dose of 2013-2014 seasonal influenza vaccination before or not.
Who cannot join
- .Subject or his/her family is employed by the participated hospital;
- .History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- .Personal or family history of Guillain-Barré Syndrome;
- .An acute febrile illness within 1 week prior to vaccination;
- .Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
- .Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
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- .Female subjects who are pregnant during the study.
- .Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
- .Immunodeficiency, or under immunosuppressive treatment.
- .Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
- .Receipt of any blood products, including immunoglobulin in the prior 3 months;
- .Any severe illness needed to be hospitalization within three months.
- .Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University
Tainan, Taiwan, 704
Yu-Tzu Chang, MD
About this study
Official title: The Immunogenicity and Safety of the Seasonal Influenza Vaccine, Formulation 2013-2014, in Chronic Kidney Disease Patients Not on Dialysis
In recent years, several studies revealed that the current influenza vaccine strategy might be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and mortality in the end-stage renal disease population than previously thought. Thus, this also raised the question about the effectiveness of administration of influenza vaccination in chronic kidney disease patients not on dialysis. In this study, the investigators aim to evaluate the effectiveness of seasonal trivalent influenza vaccine, formulation 2013-2014, in patients with different stage of chronic kidney disease (CKD) not on dialysis.
Read the detailed description
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by the method of hemagglutination inhibition (HI) and ELISA-based microneutralization (microNT-ELISA) assays. All participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 4). The investigators will collect serum of participants at the 5th weeks, 9th weeks, and 21th week post vaccination and evaluate the difference of immune response in these 3 groups.
- Being tested
- Seasonal influenza vaccine (AdimFlu-S)
- Keywords
- trivalent influenza vaccine, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal influenza vaccine (AdimFlu-S)Biological
Also called AdimFlu-S, manufactured by Adimmune company.
Participants receiving 0, 1 and 2 dose of AdimFlu-S during the study period.(a) No vaccination: no any influenza vaccination during the study period.(b) One dose of AdimFlu-S group: patient will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at the initiation of the study.(c)Two doses of AdimFlu-S group: patients will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at week 0 and 4 weeks after the initiation of the study.
| Study group | Role | What they receive |
|---|---|---|
| The group receiving no influenza vaccine | No intervention | Participants in this group will not receive any influenza vaccine (negative control group). |
| One dose of AdimFlu-S group | Experimental | Participants in this group will receive one dose of the seasonal trivalent influenza vaccine (one dose of AdimFlu-S group), formulation 2013-2014, at the initiation of the study. Each administered dose contain 15 ug virus antigen for each virus strain. Receives: Biological: Seasonal influenza vaccine (AdimFlu-S) |
| Two dose of AdimFlu-S group | Experimental | Participants in this group (Two dose of AdimFlu-S group)will receive the seasonal trivalent influenza vaccine, formulation 2013-2014, at the week 0 and 4 weeks after the initiation of the study. Each administered dose contain 15 ug virus antigen for each virus strain. Receives: Biological: Seasonal influenza vaccine (AdimFlu-S) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dynamic change of seroprotection rate related to administration of influenza virus vaccine strains (2013-2014 season) of the AdimFlu-S manufactured by Adimmune Corporation.
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay might also be used to evaluate the seroprotection post vaccination, which will be defined as micro-NT titer ≥1: 40 or ≥ 1:160 .
Measured: The seroprotection rate will be assessed at 4, 8, 20 weeks after the initiation of the study.
Secondary outcomes (3)
The safety of the influenza vaccination in patients with chronic kidney disease.
Patients who received influenza vaccination would be asked to record any local or systemic side effect during the first week after vaccination. Besides, the investigators would also monitor any possible adverse effect during the whole study period.
Measured: the safety issue related to the vaccination will be assessed in each visit during the whole study period (20 weeks).
The dynamic change of seroconversion rate related to administration of influenza virus vaccine strains (2013-2014 season) of the AdimFlu-S manufactured by Adimmune Corporation.
The seroconversion is defined as the HI titer of the post-vaccination serum is at least 1:40 for those who had a negative pre-vaccination HI serum titer or a four-fold or greater increase in HI titers in subjects who had a positive pre-vaccination HAI serum titer. The seropositive is defined as the HI titer ≥ 1:10, and the seronegative is defined as HI titer < 1:10.
Measured: The seroconversion rate will be assessed at 4, 8, 20 weeks after the initiation of the study.
The dynamic change of seroresponse rate related to administration of influenza virus vaccine strains (2013-2014 season) of the AdimFlu-S manufactured by Adimmune Corporation.
The seroresponse is defined as HI or micro-NT titer of the post-vaccination serum is at least 4-fold increase of the HI or micro-NT titer after vaccination.
Measured: The seroresponse rate will be assessed at 4, 8, 20 weeks after the initiation of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunogenicity and Adverse Drug Effect of Vaccines InfluenzaStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Tzu Chang, National Cheng-Kung University Hospital
- Investigators
- Ming-Cheng Wang, MD, Principal investigator, National Cheng Kung University and HospitalChin-Chung Tseng, MD, PhD, Principal investigator, National Cheng-Kung University HospitalJunne-Ming Sung, MD, Principal investigator, National Cheng Kung University and HospitalAn-Bang Wu, MD, Principal investigator, National Cheng-Kung University HospitalWei-Hung Lin, ＭＤ, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105519
- Sponsor's protocol ID
- A-BR-101-139
- Status last verified
- Apr 2014
- First submitted
- 9 Dec 2013
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunogenicity and Safety of the Seasonal Influenza Vaccine, Formulation 2013-2014, in Chronic Kidney Disease Patients Not on Dialysis
- ClinicalTrials.gov ID
- NCT02105519
- Acronym / sponsor ID
- A-BR-101-139
- Keywords
- trivalent influenza vaccine, chronic kidney disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 7 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.
In recent years, several studies revealed that the current influenza vaccine strategy might be of minimal vaccine effectiveness and had a smaller effect on reducing morbidity and mortality in the end-stage renal disease population than previously thought. Thus, this also raised the question about the effectiveness of administration of influenza vaccination in chronic kidney disease patients not on dialysis. In this study, the investigators aim to evaluate the effectiveness of seasonal trivalent influenza vaccine, formulation 2013-2014, in patients with different stage of chronic kidney disease (CKD) not on dialysis.
Detailed description
The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by the method of hemagglutination inhibition (HI) and ELISA-based microneutralization (microNT-ELISA) assays. All participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 4). The investigators will collect serum of participants at the 5th weeks, 9th weeks, and 21th week post vaccination and evaluate the difference of immune response in these 3 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The group receiving no influenza vaccine | No intervention | –Participants in this group will not receive any influenza vaccine (negative control group). |
| One dose of AdimFlu-S group | Experimental | Biological: Seasonal influenza vaccine (AdimFlu-S)Participants in this group will receive one dose of the seasonal trivalent influenza vaccine (one dose of AdimFlu-S group), formulation 2013-2014, at the initiation of the study. Each administered dose contain 15 ug virus antigen for each virus strain. |
| Two dose of AdimFlu-S group | Experimental | Biological: Seasonal influenza vaccine (AdimFlu-S)Participants in this group (Two dose of AdimFlu-S group)will receive the seasonal trivalent influenza vaccine, formulation 2013-2014, at the week 0 and 4 weeks after the initiation of the study. Each administered dose contain 15 ug virus antigen for each virus strain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- .Males and non-pregnant females and aged ≥ 18 years with chronic kidney disease not on dialysis;
- .Willing and able to adhere to visit schedules and all study requirements;
- .Subjects read and signed the study-specific informed consent.
- .Subjects who has either received the first dose of 2013-2014 seasonal influenza vaccination before or not.
Key exclusion criteria (13 listed)
- .Subject or his/her family is employed by the participated hospital;
- .History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
- .Personal or family history of Guillain-Barré Syndrome;
- .An acute febrile illness within 1 week prior to vaccination;
- .Current upper respiratory illness, including the common cold or nasal congestion within 72 hours;
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 |
|---|---|---|
| Seasonal influenza vaccine (AdimFlu-S)Also: AdimFlu-S, manufactured by Adimmune company.Participants receiving 0, 1 and 2 dose of AdimFlu-S during the study period.(a) No vaccination: no any influenza vaccination during the study period.(b) One dose of AdimFlu-S group: patient will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at the initiation of the study.(c)Two doses of AdimFlu-S group: patients will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at week 0 and 4 weeks after the initiation of the study. | Biological | One dose of AdimFlu-S group, Two dose of AdimFlu-S group |
Primary outcome
The dynamic change of seroprotection rate related to administration of influenza virus vaccine strains (2013-2014 season) of the AdimFlu-S manufactured by Adimmune Corporation.
Time frame: The seroprotection rate will be assessed at 4, 8, 20 weeks after the initiation of the study.
The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HI titer ≥ 1:40. MicroNT-ELISA assay might also be used to evaluate the seroprotection post vaccination, which will be defined as micro-NT titer ≥1: 40 or ≥ 1:160 .
3 secondary outcomes
The safety of the influenza vaccination in patients with chronic kidney disease.
Time frame: the safety issue related to the vaccination will be assessed in each visit during the whole study period (20 weeks).
The dynamic change of seroconversion rate related to administration of influenza virus vaccine strains (2013-2014 season) of the AdimFlu-S manufactured by Adimmune Corporation.
Time frame: The seroconversion rate will be assessed at 4, 8, 20 weeks after the initiation of the study.
The dynamic change of seroresponse rate related to administration of influenza virus vaccine strains (2013-2014 season) of the AdimFlu-S manufactured by Adimmune Corporation.
Time frame: The seroresponse rate will be assessed at 4, 8, 20 weeks after the initiation of the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
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.
Ming-Cheng Wang, MD principal investigator
National Cheng Kung University and Hospital
Chin-Chung Tseng, MD, PhD principal investigator
National Cheng-Kung University Hospital
Junne-Ming Sung, MD principal investigator
National Cheng Kung University and Hospital
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 Seasonal influenza vaccine (AdimFlu-S) in people with Immunogenicity and Adverse Drug Effect of Vaccines Influenza and Chronic Kidney Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 7 Apr 2014. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Tzu Chang, MD, MSc (886-2353535 ext. 4930, kangxiemperor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dynamic change of seroprotection rate related to administration of influenza virus vaccine strains (2013-2014 season) of the AdimFlu-S manufactured by Adimmune Corporation. (time frame: The seroprotection rate will be assessed at 4, 8, 20 weeks after the initiation of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2014.