Hematopoietic Cell TransplantationPhase 2NCT03179761
High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients
A Phase 2 study testing Quadrivalent Inactivated Influenza Vaccine, Laboratory Biomarker Analysis and Trivalent Influenza Vaccine in people with Hematopoietic Cell Transplantation, run by Vanderbilt-Ingram Cancer Center at 4 sites in United States.
Trial summary
This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Cell Transplantation
- What is being tested?
- Quadrivalent Inactivated Influenza Vaccine, Laboratory Biomarker Analysis and Trivalent Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Oct 2017to 1 Oct 2024
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Allogeneic HSCT recipients who are 3-23 months post-transplant;
- ≥ 18 years of age;
- Available for duration of study;
- Patients with stable GVHD for at least 4 weeks will be eligible (stable is defined as no major change in systemic immunosuppressive therapy for worsening GVHD; adjustment of actual dose to obtain a stable target level is acceptable).
- Can be reached by telephone and/or electronic communication
- Subjects must have a platelet count of ≥30,000 to receive the immunizations. Patients requiring platelet transfusions are eligible to enroll and must have a platelet count ≥30,000 within 72 hours prior to their immunization, or platelet count ≥75,000 without transfusion documented within 30 days for subjects <12 months post- transplant and within 90 days for subjects 12-23 months post-transplant.
Who cannot join
- History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein;
- History of Guillain-Barre syndrome;
- Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerism is permitted);
- History of receiving current seasonal influenza vaccine post-transplant;
- Pregnant female;
- History of proven influenza disease after September 1, 2018 prior to enrollment;
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- Non-allogeneic (e.g. autologous) or syngeneic hematopoietic SCT recipients;
- History of known active infection with HIV
- History of cirrhosis
- History of known latex hypersensitivity;
- Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment
- Receipt of. IVIG/SCIG <28 days prior to vaccination
- Criteria for temporarily delaying vaccine administration: The following conditions are temporary or self-limiting, and a subject may be included in the study once the condition has resolved, provided that the subject is otherwise eligible:
- Fever ≥100.4ºF/38.0ºC (oral measurement), or an acute illness within 48 hours of enrollment
- Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks prior to potential study vaccination.
- Note: if patients were eligible for vaccine 1, they will be eligible to receive vaccine 2 regardless of any changes on their GVHD status, unless it is deemed not medically safe to receive influenza vaccine.
- For subjects who were enrolled and vaccinated in 2017-18, and 2018-19, the goal is to enroll these same subjects who participated the previous influenza season year and then administer the same vaccination as the previous year. These subjects are referred to as repeaters. For example, subjects enrolled in 2017-18 year were eligible to enroll again in 2018-19 as repeaters. For subjects enrolled in 2018-19 year and received at least one vaccine, will be eligible to be enrolled as repeaters for 2019-2020 season.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Alabama
Birmingham, Alabama, 35233
Northwestern University
Chicago, Illinois, 60611
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
About this study
This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Season influenza can cause more severe infections in patients who have had a stem cell transplant since their immune system doesn't work as well. Influenza vaccine may provide better protection against flu in adults.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether high dose (HD)-trivalent influenza vaccine (TIV) compared with standard dose (SD)-quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a >= 4-fold rise in hemagglutination inhibition assay (HAI) titer, >= 1:40 HAI titer, or a higher geometric mean titer (GMT) titer to influenza A antigens in adult hematopoietic cell transplantation (HSCT) recipients.
SECONDARY OBJECTIVES:
- To determine whether HD-TIV compared with SD-QIV will increase the probability of achieving a >= 4-fold rise in HAI titers, >= 1:40 HAI titer, or higher GMT titers to influenza B antigens in adult HSCT recipients.
II. To determine the frequency and severity of solicited local injection site adverse events (e.g. pain/tenderness, redness, and swelling at injection site) with HD-TIV compared to SD-QIV in adult HSCT recipients.
III. To determine the frequency and severity of solicited systemic adverse events (e.g. fevers, headache, fatigue/malaise, nausea, body ache/myalgia, general activity level, and vomiting) with HD-TIV compared to SD-QIV in adult HSCT recipients.
IV. To define the relationship between HAI titers, in vivo T and B cell phenotype, and in vitro influenza-specific T and B cell response in adult HSCT recipients receiving either HD-TIV or SD-QIV.
- To correlate HAI responses to microneutralization responses. VI. To compare the persistent HAI and microneutralization assay (MN) titers for all four antigen seven months after the last vaccine dose to assess for persistence of antibody titers.
VII. To compare influenza detection by polymerase chain reaction (PCR) during influenza season in adult HSCT recipients receiving either HD-TIV or standard dose QIV.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients receive HD-TIV intramuscularly once at baseline and once between 28-42 days.
GROUP II: Patients receive SD-QIV intramuscularly once at baseline and once between 28-42 days.
After completion of study treatment, patients are contacted at 1-3 and 8-10 days after each vaccination visit.
- Conditions
- Hematopoietic Cell Transplantation
- Being tested
- Quadrivalent Inactivated Influenza Vaccine, Laboratory Biomarker Analysis, Trivalent Influenza Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrivalent Inactivated Influenza VaccineBiological
Standard Dose Quadrivalent Influenza Vaccine given intramuscularly
Laboratory Biomarker AnalysisOther
Correlative studies
Trivalent Influenza VaccineBiological
High Dose Trivalent Influenza Vaccine given intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Group I (HD-TIV) | Experimental | Patients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later. Receives: Other: Laboratory Biomarker Analysis; Biological: Trivalent Influenza Vaccine |
| Group 2(SD-QIV) | Active comparator | Patients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later. Receives: Biological: Quadrivalent Inactivated Influenza Vaccine; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza A antigens.
Measured: Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.
Secondary outcomes (4)
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza B antigens.
Measured: Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.
Solicited Local Injection Site Adverse Events
The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol.
Solicited injection site AEs included: pain, tenderness, erythema/redness, and swelling/induration. The diameter of any erythema/redness and swelling/induration was measured to evaluate "redness size" and "swelling size."
Measured: Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.
Solicited Systemic Adverse Events
The proportion of subjects in each group experiencing at least one solicited AE with 95% posterior credible intervals, separated by vaccine number and adverse event type. AEs were assessed by clinicians using Tables 4 and 5 within section C16 of the protocol.
Solicited systemic AEs included: fevers, fatigue/malaise, headache, nausea, body ache/myalgia, generally activity, and vomiting.
Measured: Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.
Percentage of Individuals in Each Group That Test Positive for Influenza by PCR
The percentage of breakthrough flu in vaccinated participants, separated by treatment group.
Measured: Nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration 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 Jun 2017
- Study start9 Oct 2017
- Primary completion15 Feb 2022
- Study completion1 Oct 2024
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 Hematopoietic Cell TransplantationStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasha Halasa, MD, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179761
- Sponsor's protocol ID
- VICC CTT 1733
- Other IDs
- NCI-2017-00466
- Status last verified
- Nov 2024
- First submitted
- 1 Jun 2017
- Last updated
- 4 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High vs. Standard Dose Flu Vaccine in Adult Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT03179761
- Acronym / sponsor ID
- VICC CTT 1733
- Conditions
- Hematopoietic Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 7 Jun 2017 (actual)
- Results
- Posted 12 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized phase II studies the side effects of high-dose trivalent influenza vaccine or standard-dose quadrivalent inactivated influenza and how well they work in treating adult patients undergoing stem cell transplant. Season influenza can cause more severe infections in patients who have had a stem cell transplant since their immune system doesn't work as well. Influenza vaccine may provide better protection against flu in adults.
Detailed description
PRIMARY OBJECTIVES:
- To determine whether high dose (HD)-trivalent influenza vaccine (TIV) compared with standard dose (SD)-quadrivalent inactivated influenza vaccine (QIV) will increase the probability of achieving a >= 4-fold rise in hemagglutination inhibition assay (HAI) titer, >= 1:40 HAI titer, or a higher geometric mean titer (GMT) titer to influenza A antigens in adult hematopoietic cell transplantation (HSCT) recipients.
SECONDARY OBJECTIVES:
- To determine whether HD-TIV compared with SD-QIV will increase the probability of achieving a >= 4-fold rise in HAI titers, >= 1:40 HAI titer, or higher GMT titers to influenza B antigens in adult HSCT recipients.
II. To determine the frequency and severity of solicited local injection site adverse events (e.g. pain/tenderness, redness, and swelling at injection site) with HD-TIV compared to SD-QIV in adult HSCT recipients.
III. To determine the frequency and severity of solicited systemic adverse events (e.g. fevers, headache, fatigue/malaise, nausea, body ache/myalgia, general activity level, and vomiting) with HD-TIV compared to SD-QIV in adult HSCT recipients.
IV. To define the relationship between HAI titers, in vivo T and B cell phenotype, and in vitro influenza-specific T and B cell response in adult HSCT recipients receiving either HD-TIV or SD-QIV.
- To correlate HAI responses to microneutralization responses. VI. To compare the persistent HAI and microneutralization assay (MN) titers for all four antigen seven months after the last vaccine dose to assess for persistence of antibody titers.
VII. To compare influenza detection by polymerase chain reaction (PCR) during influenza season in adult HSCT recipients receiving either HD-TIV or standard dose QIV.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients receive HD-TIV intramuscularly once at baseline and once between 28-42 days.
GROUP II: Patients receive SD-QIV intramuscularly once at baseline and once between 28-42 days.
After completion of study treatment, patients are contacted at 1-3 and 8-10 days after each vaccination visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (HD-TIV) | Experimental | Other: Laboratory Biomarker Analysis, Biological: Trivalent Influenza VaccinePatients received HD-TIV intramuscularly once at baseline (day 0) and again between 28-42 days later. |
| Group 2(SD-QIV) | Active comparator | Biological: Quadrivalent Inactivated Influenza Vaccine, Other: Laboratory Biomarker AnalysisPatients received SD-QIV intramuscularly once at baseline (day 0) and again between 28-42 days later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Allogeneic HSCT recipients who are 3-23 months post-transplant;
- ≥ 18 years of age;
- Available for duration of study;
- Patients with stable GVHD for at least 4 weeks will be eligible (stable is defined as no major change in systemic immunosuppressive therapy for worsening GVHD; adjustment of actual dose to obtain a stable target level is acceptable).
- Can be reached by telephone and/or electronic communication
Key exclusion criteria (17 listed)
- History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein;
- History of Guillain-Barre syndrome;
- Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerism is permitted);
- History of receiving current seasonal influenza vaccine post-transplant;
- Pregnant female;
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 |
|---|---|---|
| Quadrivalent Inactivated Influenza VaccineStandard Dose Quadrivalent Influenza Vaccine given intramuscularly | Biological | Group 2(SD-QIV) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group 2(SD-QIV), Group I (HD-TIV) |
| Trivalent Influenza VaccineHigh Dose Trivalent Influenza Vaccine given intramuscularly | Biological | Group I (HD-TIV) |
Primary outcome
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity
Time frame: Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.
Point estimates and 95% confidence intervals for proportion of subjects achieving seroprotection (≥1:40 HAI titer) and seroconversion (4-fold or greater rise in HAI titers from visit 1) for Influenza A antigens.
4 secondary outcomes
HD-TIV Compared With SD-QIV (Influenza B) - Immunogenicity
Time frame: Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.
Solicited Local Injection Site Adverse Events
Time frame: Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.
Solicited Systemic Adverse Events
Time frame: Adverse events were recorded for 7 days following each vaccination or until resolution, up to study conclusion.
Percentage of Individuals in Each Group That Test Positive for Influenza by PCR
Time frame: Nasal swabs were collected at each study visit or within 48 hours if a subject presented with influenza-like symptoms throughout the duration of the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Quadrivalent Inactivated Influenza Vaccine, Laboratory Biomarker Analysis and Trivalent Influenza Vaccine in people with Hematopoietic Cell Transplantation, run by Vanderbilt-Ingram Cancer Center at 4 sites 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 6 inclusion and 17 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 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Jan 2023). 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?
HD-TIV Compared With SD-QIV (Influenza A) - Immunogenicity (time frame: Visit 1 titers (baseline) were measured on day 0; visit 2 titers were measured 28-42 days after visit 1; visit 3 titers were measured 28-42 days after visit 2; and visit 4 titers were measured 138-222 days after visit 2.). 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 4 Dec 2024.