Evaluating immune responses to the flu vaccine in healthy adults
Longitudinal Analysis of Bone Marrow and Peripheral Blood Immune Responses to Influenza Vaccination in a Healthy Adult Cohort
This study tests how well the flu vaccine works in healthy adults by looking at their immune responses over the course of a year.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT05616546 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the immune response generated by the killed influenza vaccine in healthy volunteers. Participants will receive a licensed seasonal inactivated flu vaccine and provide blood and bone marrow samples for analysis. The study will monitor humoral immunity at multiple time points: 7 days, 28 days, 90 days, and one year post-vaccination. Researchers will evaluate the magnitude, clonal diversity, and persistence of B-cell responses to the vaccine over time.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults who can provide informed consent.
Not a fit: Patients who are pregnant, nursing, or have cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of immune responses to the flu vaccine, potentially leading to improved vaccination strategies.
How similar studies have performed: Other studies have shown success in evaluating immune responses to vaccines, making this approach both relevant and supported by prior research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Atlanta, Georgia
- Emory University Hospital — Atlanta, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Edmund K Waller, MD, PhD — Emory University
- Study coordinator: Jennifer C Truell, MA, MPH
- Email: jennifer.carter.truell@emory.edu
- Phone: 404-778-0014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.