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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07493460
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Healthy Adults
  • Immunology

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • trivalent inactivated influenza vaccine (TIV) — BIOLOGICAL
    TIV
  • nonavalent HPV vaccine (HPV) — BIOLOGICAL
    HPV
  • hepatitis A (HAV) vaccines — BIOLOGICAL
    HAV
  • tetanus, diphtheria and acellular pertussis vaccine (Tdap) — BIOLOGICAL
    Tdap

Study Details

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.

Key Dates

Start date
Aug 26, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Vaccination
    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.

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: day 29 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of Medicine Infectious Disease Clinical Research UnitSt LouisMissouri63110-

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Washington University School of Medicine Infectious Disease Clinical Research Unit· St Louis, MO

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