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

NCT07493460 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-22

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

trivalent inactivated influenza vaccine (TIV)

TIV

BIOLOGICAL

nonavalent HPV vaccine (HPV)

HPV

BIOLOGICAL

hepatitis A (HAV) vaccines

HAV

BIOLOGICAL

tetanus, diphtheria and acellular pertussis vaccine (Tdap)

Tdap

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Patrick D Olson, MD PhD · Washington University School of Medicine Infectious Disease Clinical Research Unit

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2026-08-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07493460 on ClinicalTrials.gov