ImmunologyPhase 4WU 445NCT07493460
Longitudinal Tracking of Bone Marrow Plasma Cell Responses to Licensed Human Vaccines
A Phase 4 study testing trivalent inactivated influenza vaccine (TIV), nonavalent HPV vaccine (HPV) and hepatitis A (HAV) vaccines in people with Immunology and Healthy Adults, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunology, Healthy Adults
- What is being tested?
- trivalent inactivated influenza vaccine (TIV), nonavalent HPV vaccine (HPV) and hepatitis A (HAV) vaccines
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants over 18 years of age.
- Able to understand and give informed consent.
- Willing to receive TIV, Tdap, HPV, and HAV vaccinations
- In stable health, as determined by medical history and targeted physical exam related to this history.
- Willing to give BMA samples
- 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
Who cannot join
- 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.
- Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
- 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.
- 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.
- 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.
- 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.
Show all 13Show fewer
- 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.
- Has received the 2025-2026 influenza trivalent, inactivated vaccine or quadrivalent, inactivated vaccine.
- Has received any quadrivalent or trivalent inactivated influenza, Tdap, HPV, or HAV vaccines ≤ 180 days prior to the injection (Day 1).
- Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
- 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.
- Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
- Coagulopathy (primary or iatrogenic) which would contraindicate bone marrow aspirate or core biopsy for participants willing to have those procedures done
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine Infectious Disease Clinical Research Unit
St Louis, Missouri, 63110
About this study
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:
Read more
- 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
- Immunology, Healthy Adults
- Being tested
- trivalent inactivated influenza vaccine (TIV), nonavalent HPV vaccine (HPV), hepatitis A (HAV) vaccines, tetanus, diphtheria and acellular pertussis vaccine (Tdap)
- Keywords
- physiology, Plasma Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trivalent inactivated influenza vaccine (TIV)Biological
TIV
nonavalent HPV vaccine (HPV)Biological
HPV
hepatitis A (HAV) vaccinesBiological
HAV
tetanus, diphtheria and acellular pertussis vaccine (Tdap)Biological
Tdap
| Study group | Role | What they receive |
|---|---|---|
| Vaccination | Experimental | 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. Receives: Biological: trivalent inactivated influenza vaccine (TIV); Biological: nonavalent HPV vaccine (HPV); Biological: hepatitis A (HAV) vaccines; Biological: tetanus, diphtheria and acellular pertussis vaccine (Tdap) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
The antibody titer for influenza strains at d29 when compared to baseline
Measured: day 29
Secondary outcomes (1)
Frequency of serious adverse events
Frequency of serious adverse events
Measured: at days 29, 57, 91, 181, 366, 546, and 731
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start26 Aug 2025
- Primary completionOct 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunologyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick D Olson, MD PhD, Principal investigator, Washington University School of Medicine Infectious Disease Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493460
- Sponsor's protocol ID
- 202507157
- Other IDs
- U19AI181103, U01AI141990
- Acronym
- WU 445
- Status last verified
- Jun 2026
- First submitted
- 1 Oct 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data to be generated and shared from this proposal will include clinical data with low-risk for identification, clinical from patients from human cohorts (described in more detail in the proposal) and a wealth of immunological data generated from assays performed on the clinical specimens derived from these subjects. The types of data to be uploaded include mainly .xls(x) or fasta files but also potentially .pdf, .doc(x), and .txt files
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Tracking of Bone Marrow Plasma Cell Responses to Licensed Human Vaccines
- ClinicalTrials.gov ID
- NCT07493460
- Acronym / sponsor ID
- WU 445 / 202507157
- Conditions
- Immunology, Healthy Adults
- Keywords
- physiology, Plasma Cells
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination | Experimental | Biological: trivalent inactivated influenza vaccine (TIV), Biological: nonavalent HPV vaccine (HPV), Biological: hepatitis A (HAV) vaccines, Biological: tetanus, diphtheria and acellular pertussis vaccine (Tdap)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy participants over 18 years of age.
- Able to understand and give informed consent.
- Willing to receive TIV, Tdap, HPV, and HAV vaccinations
- In stable health, as determined by medical history and targeted physical exam related to this history.
- Willing to give BMA samples
Key exclusion criteria (13 listed)
- 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.
- Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trivalent inactivated influenza vaccine (TIV)TIV | Biological | Vaccination |
| nonavalent HPV vaccine (HPV)HPV | Biological | Vaccination |
| hepatitis A (HAV) vaccinesHAV | Biological | Vaccination |
| tetanus, diphtheria and acellular pertussis vaccine (Tdap)Tdap | Biological | Vaccination |
Primary outcome
Primary Outcome Measure
Time frame: day 29
The antibody titer for influenza strains at d29 when compared to baseline
1 secondary outcome
Frequency of serious adverse events
Time frame: at days 29, 57, 91, 181, 366, 546, and 731
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. The data to be generated and shared from this proposal will include clinical data with low-risk for identification, clinical from patients from human cohorts (described in more detail in the proposal) and a wealth of immunological data generated from assays performed on the clinical specimens derived from these subjects. The types of data to be uploaded include mainly .xls(x) or fasta files but also potentially .pdf, .doc(x), and .txt files
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick D Olson, MD PhD principal investigator
Washington University School of Medicine Infectious Disease Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing trivalent inactivated influenza vaccine (TIV), nonavalent HPV vaccine (HPV) and hepatitis A (HAV) vaccines in people with Immunology and Healthy Adults, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.