How age affects germinal center responses after flu and rabies vaccines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 4 study compares immune responses to two FDA-approved vaccines—the seasonal flu vaccine and RabAvert—between younger and older healthy adults. Blood samples and optional lymph node fine-needle aspirates will be collected to study antibody production and memory immune cells over time. The goal is to understand age-related differences in how germinal centers form and support long-lasting immunity after vaccination. The trial is led by Washington University School of Medicine with collaboration from NIAID and the Gates Foundation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Healthy participants 18 to 40 years of age or ≥65 years of age.
2. Able to understand and give informed consent.
3. Willing to receive RabAvert vaccine.
4. Willing to receive TIV (trivalent influenza vaccine).
5. In stable health, as determined by medical history and targeted physical exam related to this history.
6. Willing to give blood and optional lymph node FNA (fine needle aspiration) samples.

Exclusion Criteria:

1. Has a history of severe local or systemic reactions to any vaccination.
2. Has a history of severe allergic reaction to any component of the rabies or influenza vaccines.
3. Has a history of prior rabies vaccination, receipt of rabies post-exposure prophylaxis or rabies immunoglobulin, or known or suspected prior exposure to rabies virus.
4. Has received any influenza vaccines ≤ 180 days prior to the day of injection (Day 1).
5. Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
6. Has received systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
7. Is acutely ill or febrile (temperature \>38.0 C \[100.4F\] less than 72 hours prior to or at the Day 1 visit. Participants who meet this criterion may be rescheduled.
8. Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator.
9. History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
10. Has received any vaccine ≤ 28 days prior to the injection (Day 1) or plans to receive a vaccine within 28 days before or after the study injection. These participants may be rescheduled.
11. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
12. Have donated blood, blood products or bone marrow within 30 days before study vaccination, plan to donate blood at any time during the duration of participant study participation, or plan to donate blood within 30 days after the last blood draw.
13. Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
14. Unwilling to use an effective method of contraception if you are of childbearing potential.

Where it's running

• Washington University
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Patrick Olson, MD
• Email: olsonp@wustl.edu
• Phone: 314-454-0058

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.