NCT05616546 Bone Marrow and Peripheral Blood Immune Responses Study
| NCT ID | NCT05616546 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Emory University |
| Condition | Influenza |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2023-10-16 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Contact & Investigator
Edmund K Waller, MD, PhD
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05616546 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Influenza. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05616546 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05616546 currently recruiting?
Yes, NCT05616546 is actively recruiting participants. Contact the research team at jennifer.carter.truell@emory.edu for enrollment information.
Where is the NCT05616546 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT05616546 clinical trial?
NCT05616546 is sponsored by Emory University. The principal investigator is Edmund K Waller, MD, PhD at Emory University. The trial plans to enroll 90 participants.