Influenza, HumanPhase 4NCT01808456
Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant.
A Phase 4 study testing influenza trivalent inactive vaccine and influenza trivalent inactive vaccine high dose in people with Influenza, Human and Transplantation Infection, run by Inova Health Care Services at 1 site in United States.
Trial summary
Influenza infection in recipients of solid organ transplants recipients while on maintenance immunosuppressant therapy is associated with increased morbidity and mortality. Although influenza vaccination is recommended in these high-risk patients, safety and immunogenicity of commercially available different strengths… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Influenza, Human, Transplantation Infection
- What is being tested?
- influenza trivalent inactive vaccine and influenza trivalent inactive vaccine high dose
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults age ≥18 years of age following solid organ transplants (kidney, heart and lung) of all races and gender unless as specified in the exclusion criteria.
- At least 30 days after organ transplantation of kidney, heart, or lung.
- In good health as determined by a) medical history, b) physical examinations, c) clinical judgment of the investigator team.
- Informed consent will be obtained from all the subjects before enrollment into the study, after the nature of the study has been fully explained to the satisfaction of the participant.
- Non-English speaking persons will be included ONLY if consent can be obtained with the help of the translator or interpreter.
Who cannot join
- Less than 30 days after transplantation procedure.
- Post operative complications of any type.
- Transplant organ dysfunction and/or under evaluation for possible infection.
- Recent acute transplant rejection and treatment for rejection for the past 30 days.
- Receiving another investigational drug or biologic for transplant.
- Previous history of allergic reaction to influenza vaccine, chicken egg or other unknown allergic reactions to flu vaccine or other vaccines.
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- Acute ongoing respiratory illness.
- Bleeding diathesis or on anticoagulation therapy.
- Major surgery (pre-arranged) planned during the study period.
- Any condition that may preclude the participant from completion of study related activities; such as planned travel, or out of the state of residence and not able to return for follow-up visits or relocation of residence.
- Females of reproductive age unless proven to be urine HCG negative at the time of participation.
- Recent opportunistic infection, such as CMV, EBV, BK viral reactivation, or any other documented or laboratory confirmed opportunistic infection or on treatment for confirmed infection.
- Vulnerable subjects such as aged less than 18 years, pregnant women, nursing home residents or other institutionalized persons, students, employees, prisoners, and persons who may not be able to make independent decisions or is considered to have a cognitive impairment, or non-English speaking in the absence of a reliable interpreter or translator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
Official title: Phase IV, Pilot, Randomized, Investigator-blinded, Study to Evaluate the Reactogenicity and Immunogenicity of Standard-dose Versus High-dose Inactivated Influenza Vaccine After Kidney, Heart and Lung Transplantation.
Influenza infection in recipients of solid organ transplants recipients while on maintenance immunosuppressant therapy is associated with increased morbidity and mortality. Although influenza vaccination is recommended in these high-risk patients, safety and immunogenicity of commercially available different strengths of influenza vaccine have not been established.
The primary study objective is to determine the safety and immunogenicity of Fluzone and Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are commercially available for use in the general population. Fluzone is approved for use in 6 months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and older.
Read more
This is an exploratory, open-label, parallel group, observer blinded, prospective study. All recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be eligible for enrollment.
Enrolled patients will be followed for three months (a total of 4 visits) following enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and 12.
Read the detailed description
A potential strategy to enhance immune responses to influenza vaccine in this patient population could be to use different strengths of TIV. One of the pathways that can improve the immunogenicity of inactivated vaccines is to increase the dose of influenza antigens contained in the vaccine. Studies have demonstrated that increasing the dose of the influenza virus hemagglutinin for each of the commonly encountered viral strains beyond the conventional dose of 15 microgram for each strain is associated with dose-dependent increase in serum antibody titers.
Influenza TIV is commercially available in two different strengths, Fluzone as well as Fluzone High-Dose, and it is valuable because of variable immunogenic potency of different strengths. Fluzone is approved for use in persons 6 months of age and older. High-dose Fluzone is approved for use in persons 65 years of age and older.
The purpose of this exploratory study is to assess the safety, tolerability, and immunogenicity of these two commercially available different strengths of TIV in solid organ transplant recipients (kidney, heart and lung) in the period after 30 days after transplant procedure. We will evaluate the safety, tolerability (reactogenicity) and immunogenicity of two different strengths of commercially available TIV in a single center, cluster randomization, investigator blinded, study by enrolling patients in the post-transplant clinic at Inova Fairfax Hospital from: August 1, 2013 - March 31, 2014; and August 1, 2014 to March 31, 2015.
Study protocol will remain active till December 31, 2016. All bio-specimens will be stored till December 31, 2016.
- Conditions
- Influenza, Human, Transplantation Infection
- Being tested
- influenza trivalent inactive vaccine, influenza trivalent inactive vaccine high dose
- Keywords
- kidney transplant, heart transplant, lung transplant, 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.
influenza trivalent inactive vaccineBiological
Also called Fluzone(R), flu vaccine
one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
influenza trivalent inactive vaccine high doseBiological
Also called Fluzone High Dose (R)
one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
| Study group | Role | What they receive |
|---|---|---|
| High Dose Flu Vaccine | Experimental | influenza trivalent inactive vaccine high dose. IM (intramuscular) injection one time administration Receives: Biological: influenza trivalent inactive vaccine high dose |
| Flu Vaccine | Active comparator | influenza trivalent inactive vaccine IM injection one time administration Receives: Biological: influenza trivalent inactive vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Local Site Reactions
Evaluation of local and systemic reactions, use of analgesics or antipyretics.
Measured: Day 1 and weeks 1, 4, and 12
Measurement of Strain-specific Hemagglutination Inhibition (HI) Antibody Titers
Number of patients and percentage of subjects achieving hemagglutination inhibition (HI) titer≥40
Measured: Week 1, 4, and 12
Secondary outcomes (2)
All Cause ED Visits/Unscheduled Clinic Visits
All-cause outpatient/Emergency department visits during study follow-up (other than pre-specified post transplant follow-up visits).
Measured: day 1 - 3 months
Number and Percentage of Subjects in Each Group Achieving Seroconversion for Each Strain
Number and percentage of subjects in each group achieving seroconversion (at least 4-fold increase in titers from baseline) for each any strain at weeks 4 and 12
Measured: Week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Influenza, HumanStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravinder Wali, MD, Principal investigator, Inova Fairfax Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808456
- Sponsor's protocol ID
- IFH20132015
- Status last verified
- Jul 2022
- First submitted
- 4 Mar 2013
- Last updated
- 22 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Pilot, Randomized, Investigator-blinded, Study to Evaluate the Reactogenicity and Immunogenicity of Standard-dose Versus High-dose Inactivated Influenza Vaccine After Kidney, Heart and Lung Transplantation.
- ClinicalTrials.gov ID
- NCT01808456
- Acronym / sponsor ID
- IFH20132015
- Conditions
- Influenza, Human, Transplantation Infection
- Keywords
- kidney transplant, heart transplant, lung transplant, influenza vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Posted 22 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Influenza infection in recipients of solid organ transplants recipients while on maintenance immunosuppressant therapy is associated with increased morbidity and mortality. Although influenza vaccination is recommended in these high-risk patients, safety and immunogenicity of commercially available different strengths of influenza vaccine have not been established.
The primary study objective is to determine the safety and immunogenicity of Fluzone and Fluzone High-Dose, with a secondary objective to determine the tolerability and efficacy of two different strengths of trivalent influenza vaccine (TIV, flu vaccine). Both vaccines are commercially available for use in the general population. Fluzone is approved for use in 6 months of age and older, and Fluzone High-Dose is approved for use in 65 years of age and older.
This is an exploratory, open-label, parallel group, observer blinded, prospective study. All recipients of kidney, lung, heart transplants who attend for post-transplant follow-up, at least 30-days after transplantation at Inova Fairfax Hospital Transplant Center will be eligible for enrollment.
Enrolled patients will be followed for three months (a total of 4 visits) following enrollment and randomization: day 0 (enrollment) and follow-up visits at weeks 1, 4, 8, and 12.
Detailed description
A potential strategy to enhance immune responses to influenza vaccine in this patient population could be to use different strengths of TIV. One of the pathways that can improve the immunogenicity of inactivated vaccines is to increase the dose of influenza antigens contained in the vaccine. Studies have demonstrated that increasing the dose of the influenza virus hemagglutinin for each of the commonly encountered viral strains beyond the conventional dose of 15 microgram for each strain is associated with dose-dependent increase in serum antibody titers.
Influenza TIV is commercially available in two different strengths, Fluzone as well as Fluzone High-Dose, and it is valuable because of variable immunogenic potency of different strengths. Fluzone is approved for use in persons 6 months of age and older. High-dose Fluzone is approved for use in persons 65 years of age and older.
The purpose of this exploratory study is to assess the safety, tolerability, and immunogenicity of these two commercially available different strengths of TIV in solid organ transplant recipients (kidney, heart and lung) in the period after 30 days after transplant procedure. We will evaluate the safety, tolerability (reactogenicity) and immunogenicity of two different strengths of commercially available TIV in a single center, cluster randomization, investigator blinded, study by enrolling patients in the post-transplant clinic at Inova Fairfax Hospital from: August 1, 2013 - March 31, 2014; and August 1, 2014 to March 31, 2015.
Study protocol will remain active till December 31, 2016. All bio-specimens will be stored till December 31, 2016.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Flu Vaccine | Experimental | Biological: influenza trivalent inactive vaccine high doseinfluenza trivalent inactive vaccine high dose. IM (intramuscular) injection one time administration |
| Flu Vaccine | Active comparator | Biological: influenza trivalent inactive vaccineinfluenza trivalent inactive vaccine IM injection one time administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- All adults age ≥18 years of age following solid organ transplants (kidney, heart and lung) of all races and gender unless as specified in the exclusion criteria.
- At least 30 days after organ transplantation of kidney, heart, or lung.
- In good health as determined by a) medical history, b) physical examinations, c) clinical judgment of the investigator team.
- Informed consent will be obtained from all the subjects before enrollment into the study, after the nature of the study has been fully explained to the satisfaction of the participant.
- Non-English speaking persons will be included ONLY if consent can be obtained with the help of the translator or interpreter.
Key exclusion criteria (13 listed)
- Less than 30 days after transplantation procedure.
- Post operative complications of any type.
- Transplant organ dysfunction and/or under evaluation for possible infection.
- Recent acute transplant rejection and treatment for rejection for the past 30 days.
- Receiving another investigational drug or biologic for transplant.
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 |
|---|---|---|
| influenza trivalent inactive vaccineAlso: Fluzone(R), flu vaccineone time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients | Biological | Flu Vaccine |
| influenza trivalent inactive vaccine high doseAlso: Fluzone High Dose (R)one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients | Biological | High Dose Flu Vaccine |
Primary outcome
Number of Patients With Local Site Reactions
Time frame: Day 1 and weeks 1, 4, and 12
Evaluation of local and systemic reactions, use of analgesics or antipyretics.
Measurement of Strain-specific Hemagglutination Inhibition (HI) Antibody Titers
Time frame: Week 1, 4, and 12
Number of patients and percentage of subjects achieving hemagglutination inhibition (HI) titer≥40
2 secondary outcomes
All Cause ED Visits/Unscheduled Clinic Visits
Time frame: day 1 - 3 months
Number and Percentage of Subjects in Each Group Achieving Seroconversion for Each Strain
Time frame: Week 4 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ravinder Wali, MD principal investigator
Inova Fairfax 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 influenza trivalent inactive vaccine and influenza trivalent inactive vaccine high dose in people with Influenza, Human and Transplantation Infection, run by Inova Health Care Services at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 22 Jul 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 22 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Local Site Reactions (time frame: Day 1 and weeks 1, 4, and 12). The study lists 2 primary outcomes in all. 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 22 Jul 2022.