Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:19 PM
Study NCT ID:
NCT07493460
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2025-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Tracking of Bone Marrow Plasma Cell Responses to Licensed Human Vaccines
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Longitudinal Tracking of Bone Marrow Plasma Cell Responses to Licensed Human Vaccines
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WU 445
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 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U19AI181103 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01AI141990 | NIH | None | https://reporter.nih.gov/quic… | View |