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NCT07493460 · ClinicalTrials.gov registry record · Phase 4
Longitudinal Tracking of Bone Marrow Plasma Cell Responses to Licensed Human Vaccines
A Phase 4 study, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
NCT07493460: Active Phase 4 study, sponsored by Washington University School of Medicine.
NCT07493460 is a Phase 4 study that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 25 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07493460, a Phase 4 study, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
Study 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 tetanus, diphtheria, and acellular pertussis vaccine (Tdap), the nonvalent HPV (HPV) vaccine, hepatitis A virus (HAV) vaccine and undergo study procedures. Procedures will include: * medical history relevant to the study, including medications and vaccines received. * Vitals (blood pressure, pulse) and temperature * Height and weight. * Physical exams. * Receive the TIV, Tdap, HPV, and HAV vaccines. * Blood samples collected for immunologic tests and genetic analysis. * Donate bone marrow by needle aspiration at a maximum of seven visits. * Complete memory aid every evening for 7 days after vaccination Optional Procedures include: * Donate bone marrow core biopsies at the same visits * Ultrasound of lymph nodes and fine needle aspirates of lymph nodes in both arm pits at a maximum of eight separate visits There will be a screening visit and and a Day 1 where vaccinations will occur and subsequent visits at Day 8, Day 14, Day 29, Day 57, Day 121, Day 181, Day 366, Day 546, and Day 731. At each of these visits health status, vital signs and blood collection will occur. A bone marrow aspirate and lymph node aspirate will be collected at screening. The six additional bone marrow aspirates will be repeated at D29, D91, D181, D366, D546, and D731. The optional bone marrow core biopsy will also be repeated at that time. Up to seven separate visits will be scheduled for the follow-up lymph node aspirates (D29, D57, D91, D181, D366, D546, and D731) Study participation will be 24 months.
Primary Outcome
The antibody titer for influenza strains at d29 when compared to baseline
Interventions
- BIOLOGICAL trivalent inactivated influenza vaccine (TIV)
- BIOLOGICAL nonavalent HPV vaccine (HPV)
- BIOLOGICAL hepatitis A (HAV) vaccines
- BIOLOGICAL tetanus, diphtheria and acellular pertussis vaccine (Tdap)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-08-26 |
| Est. Completion | 2027-08 |
| Phase | Phase 4 |
What the registry record for NCT07493460 still lists
NCT07493460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which trivalent inactivated influenza vaccine (TIV) is the first listed.
NCT07493460 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07493460 about?
NCT07493460 is a clinical study titled "Longitudinal Tracking of Bone Marrow Plasma Cell Responses to Licensed Human Vaccines". 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 heal...
What is the current status of trial NCT07493460?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2025-08-26. Estimated completion is 2027-08.
What interventions are being tested in trial NCT07493460?
The interventions under investigation include: trivalent inactivated influenza vaccine (TIV) (BIOLOGICAL), nonavalent HPV vaccine (HPV) (BIOLOGICAL), hepatitis A (HAV) vaccines (BIOLOGICAL), tetanus, diphtheria and acellular pertussis vaccine (Tdap) (BIOLOGICAL).
Who is sponsoring clinical trial NCT07493460?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07493460's enrollment target sits among peer trials
25 1669th of 2000 higher than 302 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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