InfluenzaPhase 4NCT05616546
Bone Marrow and Peripheral Blood Immune Responses Study
A Phase 4 study testing Influenza Vaccine in people with Influenza, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2023to Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All genders, races and ethnic groups (inclusive of women and minorities) are eligible for this trial, as influenza and the associated range of clinical issues accompanying influenza infection can impact people of all genders, races and ethnic groups. It is anticipated that the distribution of study participants will be diverse with regard to these demographics.
- Adults able to provide consent on their own
- Healthy adults
Who cannot join
- Adults unable to consent
- Women who are pregnant or nursing a child may not take part in this study. If a woman of childbearing potential is enrolled in this study, she and the study doctor must agree on a method of birth control to use throughout the study. Enrollees who think that they may have gotten pregnant during the study must tell the study doctor immediately. Pregnant women will be taken out of the study.
- Prisoners
- Cognitively impaired or individuals with impaired decision-making capacity
- Individuals who are vulnerable to coercion or undue influence (human fetuses, or neonates of uncertain viability or non-viable neonates, minors/children, and cognitively impaired adults) will not be eligible for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Jennifer C. Truell, MA, MPH, 404-778-0014, jennifer.carter.truell@emory.edu
About this study
Official title: Longitudinal Analysis of Bone Marrow and Peripheral Blood Immune Responses to Influenza Vaccination in a Healthy Adult Cohort
The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness.
This is an open label and single arm observational study designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults.
Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study). Participants will donate serial samples of blood and bone marrow aspirate for immunology monitoring. Repeated measurements of humoral immunity will be obtained at 7 days, 28 days, 90 days and at one year post vaccination to assess the magnitude, clonal diversity and persistence of B-cell responses to influenza vaccination.
Read the detailed description
The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness. The immune system is the body's defense against all kinds of infections and foreign invaders. The flu vaccine is a dose of killed (inactivated) flu virus. The immune system then builds protective responses against the flu virus. These responses help attack and kill the virus. One may not get sick at all, or may have a much shorter or milder illness.
The killed flu vaccine is made from a killed influenza virus that has been split apart and modified in such a way as to not be able to grow at all in humans. The killed flu vaccine is given via an injection into your arm. The purpose of this research study is to test the immune response to a vaccination for influenza (the "flu"). Participants will be given one dose of an FDA-approved influenza vaccine. The flu vaccine used in this study is the same seasonal flu vaccine that is approved by the government for this year.
The study will measure immune response to the seasonal flu vaccine by measuring the immune response in the blood and bone marrow over a period of time, for up to 1 year post (after) vaccination. Researchers expect to see a change in the immune system in response to the flu vaccination. This response will be evaluated by comparing data obtained before flu vaccination to data collected at specified time points (0, 7, 28, 90, and 365 days) after the administration of the flu vaccine. It is possible that by measuring these differences, especially in the bone marrow, clinicians can better understand how the body responds to flu vaccination and how long the immunity lasts. This is important because it could help lead to the creation of more effective flu vaccines in the future.
Up to 90 healthy volunteers will be enrolled into the study. Subjects chosen to participate in this study will be healthy volunteers who are eligible to receive the flu vaccine. An individual's study participation will last for up to 365 days, or 1 year. Subjects who complete the study will be given the option to re-enroll if they meet enrollment criteria. The duration for this study is seven years.
This single site study will take place at Emory University. As this is a healthy volunteers study, flyers, social media posts, and electronic newsletter advertisements will be used to recruit participants for this study. Interested individuals can contact the study team to determine eligibility. We will not request any waivers of consent.
Participants will be asked, as part of the informed consent process, whether or not they agree to have their specimens used only for future research. This decision can be changed at any time by the participant without penalty. Participants who agree to take part in this study will have specimens collected for antibody determination and viral typing. Each specimen will be labeled only with a unique tracking number to protect participant's confidentiality. These samples will not be used for genetic (DNA) studies and will be stored in a coded manner indefinitely.
- Conditions
- Influenza
- Being tested
- Influenza Vaccine
- Keywords
- Influenza Vaccine, Bone Marrow, Immune Response
- 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 VaccineBiological
The vaccine used in this study will be a licensed seasonal inactivated influenza vaccine for intramuscular injection that is approved by the FDA. Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study).
| Study group | Role | What they receive |
|---|---|---|
| Influenza Vaccine | Experimental | Healthy male and female individuals aged 18-64 years will be eligible to participate in this study.
Subjects will be offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria are met each year. Subjects will be re-screened to verify continued eligibility and re-consented prior to subsequent participation and will receive new subject identifiers Receives: Biological: Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in clonal diversity of B-Cell response to Influenza in blood
Blood samples will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory.
Clonal diversity of B-Cell response to Influenza in blood will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Measured: Study Days: 0, 7, 28, 90, 365
Changes in clonal diversity of B-Cell response to Influenza in bone marrow
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory.
Clonal diversity of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Measured: Study Days 0, 28, 365
Changes in magnitude of B-Cell response to Influenza in blood
Blood samples will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory.
Magnitude of B-Cell response to Influenza will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Measured: Study Days: 0, 7, 28, 90, 365
Changes in magnitude of B-Cell response to Influenza in bone marrow
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory.
Magnitude of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Measured: Study Days 0, 28, 365
Changes in persistence of B-Cell response to Influenza in blood
Blood samples will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory.
Persistence of B-Cell response to Influenza will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Persistence of B-Cell response to Influenza in blood will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Measured: Study Days: 0, 7, 28, 90, 365
Changes in Bone marrow persistence of B-Cell response to Influenza
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory.
Persistence of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Measured: Study Days 0, 28, 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start16 Oct 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edmund Waller, Emory University
- Investigators
- Edmund K Waller, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616546
- Sponsor's protocol ID
- STUDY00003852
- Other IDs
- 75N93021C00017
- Status last verified
- Jan 2024
- First submitted
- 21 Oct 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified genomic data and de-identified health information will be shared
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Analysis of Bone Marrow and Peripheral Blood Immune Responses to Influenza Vaccination in a Healthy Adult Cohort
- ClinicalTrials.gov ID
- NCT05616546
- Acronym / sponsor ID
- STUDY00003852
- Conditions
- Influenza
- Keywords
- Influenza Vaccine, Bone Marrow, Immune Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 15 Nov 2022 (actual)
- 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.
The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness.
This is an open label and single arm observational study designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults.
Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study). Participants will donate serial samples of blood and bone marrow aspirate for immunology monitoring. Repeated measurements of humoral immunity will be obtained at 7 days, 28 days, 90 days and at one year post vaccination to assess the magnitude, clonal diversity and persistence of B-cell responses to influenza vaccination.
Detailed description
The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness. The immune system is the body's defense against all kinds of infections and foreign invaders. The flu vaccine is a dose of killed (inactivated) flu virus. The immune system then builds protective responses against the flu virus. These responses help attack and kill the virus. One may not get sick at all, or may have a much shorter or milder illness.
The killed flu vaccine is made from a killed influenza virus that has been split apart and modified in such a way as to not be able to grow at all in humans. The killed flu vaccine is given via an injection into your arm. The purpose of this research study is to test the immune response to a vaccination for influenza (the "flu"). Participants will be given one dose of an FDA-approved influenza vaccine. The flu vaccine used in this study is the same seasonal flu vaccine that is approved by the government for this year.
The study will measure immune response to the seasonal flu vaccine by measuring the immune response in the blood and bone marrow over a period of time, for up to 1 year post (after) vaccination. Researchers expect to see a change in the immune system in response to the flu vaccination. This response will be evaluated by comparing data obtained before flu vaccination to data collected at specified time points (0, 7, 28, 90, and 365 days) after the administration of the flu vaccine. It is possible that by measuring these differences, especially in the bone marrow, clinicians can better understand how the body responds to flu vaccination and how long the immunity lasts. This is important because it could help lead to the creation of more effective flu vaccines in the future.
Up to 90 healthy volunteers will be enrolled into the study. Subjects chosen to participate in this study will be healthy volunteers who are eligible to receive the flu vaccine. An individual's study participation will last for up to 365 days, or 1 year. Subjects who complete the study will be given the option to re-enroll if they meet enrollment criteria. The duration for this study is seven years.
This single site study will take place at Emory University. As this is a healthy volunteers study, flyers, social media posts, and electronic newsletter advertisements will be used to recruit participants for this study. Interested individuals can contact the study team to determine eligibility. We will not request any waivers of consent.
Participants will be asked, as part of the informed consent process, whether or not they agree to have their specimens used only for future research. This decision can be changed at any time by the participant without penalty. Participants who agree to take part in this study will have specimens collected for antibody determination and viral typing. Each specimen will be labeled only with a unique tracking number to protect participant's confidentiality. These samples will not be used for genetic (DNA) studies and will be stored in a coded manner indefinitely.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Influenza Vaccine | Experimental | Biological: Influenza VaccineHealthy male and female individuals aged 18-64 years will be eligible to participate in this study. Subjects will be offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria are met each year. Subjects will be re-screened to verify continued eligibility and re-consented prior to subsequent participation and will receive new subject identifiers |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All genders, races and ethnic groups (inclusive of women and minorities) are eligible for this trial, as influenza and the associated range of clinical issues accompanying influenza infection can impact people of all genders, races and ethnic groups. It is anticipated that the distribution of study participants will be diverse with regard to these demographics.
- Adults able to provide consent on their own
- Healthy adults
Key exclusion criteria (5 listed)
- Adults unable to consent
- Women who are pregnant or nursing a child may not take part in this study. If a woman of childbearing potential is enrolled in this study, she and the study doctor must agree on a method of birth control to use throughout the study. Enrollees who think that they may have gotten pregnant during the study must tell the study doctor immediately. Pregnant women will be taken out of the study.
- Prisoners
- Cognitively impaired or individuals with impaired decision-making capacity
- Individuals who are vulnerable to coercion or undue influence (human fetuses, or neonates of uncertain viability or non-viable neonates, minors/children, and cognitively impaired adults) will not be eligible for participation in this study.
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 VaccineThe vaccine used in this study will be a licensed seasonal inactivated influenza vaccine for intramuscular injection that is approved by the FDA. Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study). | Biological | Influenza Vaccine |
Primary outcome
Changes in clonal diversity of B-Cell response to Influenza in blood
Time frame: Study Days: 0, 7, 28, 90, 365
Blood samples will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory. Clonal diversity of B-Cell response to Influenza in blood will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Changes in clonal diversity of B-Cell response to Influenza in bone marrow
Time frame: Study Days 0, 28, 365
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory. Clonal diversity of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Changes in magnitude of B-Cell response to Influenza in blood
Time frame: Study Days: 0, 7, 28, 90, 365
Blood samples will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory. Magnitude of B-Cell response to Influenza will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Changes in magnitude of B-Cell response to Influenza in bone marrow
Time frame: Study Days 0, 28, 365
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory. Magnitude of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Changes in persistence of B-Cell response to Influenza in blood
Time frame: Study Days: 0, 7, 28, 90, 365
Blood samples will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory. Persistence of B-Cell response to Influenza will be measured on study days 0, 7, 28, 90, and 365, and compared for changes. Persistence of B-Cell response to Influenza in blood will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Changes in Bone marrow persistence of B-Cell response to Influenza
Time frame: Study Days 0, 28, 365
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical \& Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory. Persistence of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Yes. De-identified genomic data and de-identified health information will be shared
Related trials for Influenza
Not yet recruitingPhase 2/3
Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza
Influenza, Human
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Not yet recruiting
Family Physician Nudges for Influenza Vaccination Among Older Adults
Influenza Vaccination
Recruiting
Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections
COVID-19 Respiratory Infection, Influenza
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
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.
Edmund K Waller, MD, PhD principal investigator
Emory University
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 Vaccine in people with Influenza, run by Emory University 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 31 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer C Truell, MA, MPH (404-778-0014, jennifer.carter.truell@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in clonal diversity of B-Cell response to Influenza in blood (time frame: Study Days: 0, 7, 28, 90, 365). The study lists 6 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 31 Jan 2024.