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Clinical Trial NCT07493460 (WU 445) for Immunology, Healthy Adults is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Longitudinal Tracking of Bone Marrow Plasma Cell Responses to Licensed Human Vaccines (WU 445) Phase 4 25 Vaccine Study

Recruiting
Clinical Trial NCT07493460 (WU 445) is designed to study Basic Science for Immunology, Healthy Adults. It is a Phase 4 interventional study that is recruiting, having started on 26 August 2025, with plans to enroll 25 participants. Led by Washington University School of Medicine, it is expected to complete by 1 August 2027. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
This study is being done to understand and measure how the immune system responds to and remembers different types of vaccines. To do this, four vaccines approved by the U.S. Food and Drug Administration (FDA) will be given simultaneously to participants. Participants will be volumteers who are healthy adults (18 years old or older) and willing to receive the yearly trivalent inactivated influenza vaccine (TIV), the ...Show More
Official Title

Longitudinal Tracking of Bone Marrow Plasma Cell Responses to Licensed Human Vaccines

Conditions
ImmunologyHealthy Adults
Other Study IDs
NCT ID Number
NCT07493460
Start Date (Actual)
2025-08-26
Last Update Posted
2026-03-25
Completion Date (Estimated)
2027-08
Enrollment (Estimated)
25
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
physiology
Plasma Cells
Primary Purpose
Basic Science
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalVaccination
four licensed vaccines administered intramuscularly at a single visit: trivalent inactivated influenza vaccine (TIV) and the tetanus, diphtheria and acellular pertussis vaccine (Tdap) in the left arm, and the nonavalent HPV vaccine (HPV) and hepatitis A (HAV) vaccines in the right arm.
trivalent inactivated influenza vaccine (TIV)
TIV
nonavalent HPV vaccine (HPV)
HPV
hepatitis A (HAV) vaccines
HAV
tetanus, diphtheria and acellular pertussis vaccine (Tdap)
Tdap
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Primary Outcome Measure
The antibody titer for influenza strains at d29 when compared to baseline
day 29
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Frequency of serious adverse events
Frequency of serious adverse events
at days 29, 57, 91, 181, 366, 546, and 731
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  1. Healthy participants over 18 years of age.
  2. Able to understand and give informed consent.
  3. Willing to receive TIV, Tdap, HPV, and HAV vaccinations
  4. In stable health, as determined by medical history and targeted physical exam related to this history.
  5. Willing to give BMA samples
  6. For those willing to give FNA or BMCB samples, Willing to:

give FNA specimens OR give BMCB specimens OR give both FNA and BMCB specimens

  1. Has a history of severe allergic reaction to any component of the TIV, Tdap, HPV, or HAV vaccines, including allergic reactions to neomycin, yeast or prior severe reaction after vaccination including anaphylaxis or encephalopathy within 7 days of vaccination.
  2. Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
  3. 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.
  4. 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 criteria may be rescheduled.
  5. 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.
  6. 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.
  7. 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.
  8. Has received the 2025-2026 influenza trivalent, inactivated vaccine or quadrivalent, inactivated vaccine.
  9. Has received any quadrivalent or trivalent inactivated influenza, Tdap, HPV, or HAV vaccines ≤ 180 days prior to the injection (Day 1).
  10. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
  11. 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.
  12. Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
  13. Coagulopathy (primary or iatrogenic) which would contraindicate bone marrow aspirate or core biopsy for participants willing to have those procedures done
Washington University School of Medicine logoWashington University School of Medicine462 active studies to explore
National Institute of Allergy and Infectious Diseases (NIAID) logoNational Institute of Allergy and Infectious Diseases (NIAID)408 active studies to explore
Study Central Contact
Contact: Michael Klebert, RN PhD ANP BC, 314-747-1098, [email protected]
Contact: Christine Lee, BS, [email protected]
1 Study Locations in 1 Countries

Missouri

Washington University School of Medicine Infectious Disease Clinical Research Unit, St Louis, Missouri, 63110, United States
Michael Klebert, RN PhD, Contact, 3147471098, [email protected]
Christine Lee, Contact, [email protected]
Patrick D Olson, MD PhD, Principal Investigator
Rachel Presti, MD PhD, Sub-Investigator
Recruiting