Healthy Adult ParticipantsPhase 4NCT07914673
Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
A Phase 4 study testing Trivalent inactivated influenza vaccine and RabAvert in people with Healthy Adult Participants and Age 65 and Older, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is being done to better understand how the immune system responds to vaccination against influenza and rabies. Researchers want to study how immune responses develop and change over time in the blood and in the lymph nodes that drain the vaccination site, following vaccination with two vaccines licensed by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Adult Participants, Age 65 and Older, Age 18 to 40
- What is being tested?
- Trivalent inactivated influenza vaccine and RabAvert
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to 25 Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy participants 18 to 40 years of age or ≥65 years of age.
- Able to understand and give informed consent.
- Willing to receive RabAvert vaccine.
- Willing to receive TIV (trivalent influenza vaccine).
- In stable health, as determined by medical history and targeted physical exam related to this history.
- Willing to give blood and optional lymph node FNA (fine needle aspiration) samples.
Who cannot join
- Has a history of severe local or systemic reactions to any vaccination.
- Has a history of severe allergic reaction to any component of the rabies or influenza vaccines.
- Has a history of prior rabies vaccination, receipt of rabies post-exposure prophylaxis or rabies immunoglobulin, or known or suspected prior exposure to rabies virus.
- Has received any influenza vaccines ≤ 180 days prior to the day of injection (Day 1).
- 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.
Show all 14Show fewer
- 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 criterion 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.
- 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.
- 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.
- Unwilling to use an effective method of contraception if you are of childbearing potential.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University
St Louis, Missouri, 63110
Patrick Olson, MD, 314-454-0058, olsonp@wustl.edu
Rachel Presti, MD, 314-454-0058, prestir@wustl.edu
About this study
This study is being done to better understand how the immune system responds to vaccination against influenza and rabies. Researchers want to study how immune responses develop and change over time in the blood and in the lymph nodes that drain the vaccination site, following vaccination with two vaccines licensed by the U.S. Food and Drug Administration (FDA): the seasonal trivalent influenza vaccine (TIV) and the rabies vaccine (RabAvert). By studying these samples, researchers hope to learn how the body produces high-quality, long-lasting antibody and memory immune responses after vaccination. The study will also compare immune responses in younger adults to immune responses in older adults, because prior research suggests that the immune system's ability to respond to vaccination weakens with age.
- Conditions
- Healthy Adult Participants, Age 65 and Older, Age 18 to 40, Immunology
- Being tested
- Trivalent inactivated influenza vaccine, RabAvert
- Keywords
- Influenza Vaccination, Rabies Vaccination, bone marrow plasma cells
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent inactivated influenza vaccineBiological
Standard, seasonal flu vaccines
RabAvertBiological
Rabies vaccine for pre-exposure
| Study group | Role | What they receive |
|---|---|---|
| Vaccination | Experimental | Standard, seasonal flu vaccine Receives: Biological: Trivalent inactivated influenza vaccine; Biological: RabAvert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabies-specific antibody titers at day 29 compared to pre-vaccination baseline.
Measured: From vaccination day 1 to day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start25 Sep 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion25 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914673
- Sponsor's protocol ID
- 202607188
- Other IDs
- U19AI181103
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 3 Nov 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
- ClinicalTrials.gov ID
- NCT07914673
- Acronym / sponsor ID
- 202607188
- Conditions
- Healthy Adult Participants, Age 65 and Older, Age 18 to 40, Immunology
- Keywords
- Influenza Vaccination, Rabies Vaccination, bone marrow plasma cells
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation
- Study start
- 25 Sep 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 25 Sep 2027 (estimated)
- First posted
- 3 Nov 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 better understand how the immune system responds to vaccination against influenza and rabies. Researchers want to study how immune responses develop and change over time in the blood and in the lymph nodes that drain the vaccination site, following vaccination with two vaccines licensed by the U.S. Food and Drug Administration (FDA): the seasonal trivalent influenza vaccine (TIV) and the rabies vaccine (RabAvert). By studying these samples, researchers hope to learn how the body produces high-quality, long-lasting antibody and memory immune responses after vaccination. The study will also compare immune responses in younger adults to immune responses in older adults, because prior research suggests that the immune system's ability to respond to vaccination weakens with age.
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, Biological: RabAvertStandard, seasonal flu vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy participants 18 to 40 years of age or ≥65 years of age.
- Able to understand and give informed consent.
- Willing to receive RabAvert vaccine.
- Willing to receive TIV (trivalent influenza vaccine).
- In stable health, as determined by medical history and targeted physical exam related to this history.
Key exclusion criteria (14 listed)
- Has a history of severe local or systemic reactions to any vaccination.
- Has a history of severe allergic reaction to any component of the rabies or influenza vaccines.
- Has a history of prior rabies vaccination, receipt of rabies post-exposure prophylaxis or rabies immunoglobulin, or known or suspected prior exposure to rabies virus.
- Has received any influenza vaccines ≤ 180 days prior to the day of injection (Day 1).
- Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
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 vaccineStandard, seasonal flu vaccines | Biological | Vaccination |
| RabAvertRabies vaccine for pre-exposure | Biological | Vaccination |
Primary outcome
Rabies-specific antibody titers at day 29 compared to pre-vaccination baseline.
Time frame: From vaccination day 1 to day 29
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 3 Nov 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.
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 and RabAvert in people with Healthy Adult Participants and Age 65 and Older, 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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 Nov 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?
Contact Patrick Olson, MD (314-454-0058, olsonp@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rabies-specific antibody titers at day 29 compared to pre-vaccination baseline. (time frame: From vaccination day 1 to 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 3 Nov 2026.