Recruiting
Phase 4

Immune Responses

Sponsor:

Emory University

Code:

NCT05616546

Conditions

Influenza

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

Influenza Vaccine

Study Details

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.

Conditions

Influenza

Study ID

NCT05616546

Start date

Oct 16, 2023

Status verified date

Jan, 2024

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Influenza Vaccine

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

Interventions

Influenza Vaccine

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).

Primary outcome measure

  • Changes in clonal diversity of B-Cell response to Influenza in blood [ Time Frame: Study Days: 0, 7, 28, 90, 365 ]
  • Changes in clonal diversity of B-Cell response to Influenza in bone marrow [ Time Frame: Study Days 0, 28, 365 ]
  • Changes in magnitude of B-Cell response to Influenza in blood [ Time Frame: Study Days: 0, 7, 28, 90, 365 ]
  • Changes in magnitude of B-Cell response to Influenza in bone marrow [ Time Frame: Study Days 0, 28, 365 ]
  • Changes in persistence of B-Cell response to Influenza in blood [ Time Frame: Study Days: 0, 7, 28, 90, 365 ]
  • Changes in Bone marrow persistence of B-Cell response to Influenza [ Time Frame: Study Days 0, 28, 365 ]

Central Contacts and Locations

Central contacts

Jennifer C Truell, MA, MPH

404-778-0014jennifer.carter.truell@emory.edu

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Jennifer C. Truell, MA, MPH

404-778-0014jennifer.carter.truell@emory.edu

More Information

Sponsor

Emory University

Last update posted

Jan 31, 2024

Last verified

Jan, 2024

Keywords

  • Influenza Vaccine
  • Bone Marrow
  • Immune Response

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Emory University on 2024-01-31. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.