ClinicalTrials.gg
RecruitingNCT07914673Updated Nov 3, 2026

Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans

A Phase 4 interventional study of Trivalent inactivated influenza vaccine and RabAvert in Healthy Adult Participants, Age 65 and Older and Age 18 to 40, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Basic science

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 965 studies in Influenza, Human with a site in United States — 60 open to participants now, 84 under way, 7 of them phase 3. Influenza, Human · United States.

Planned enrollment
712th of 842
40 · median 273
Started
2026
with 25 others
Phase 4
146 of 965
8 open now
Primary completion
2027-02
later than 27 of 82 live
Registered
964th of 965
by date

Among the 965 studies in Influenza, Human with a site in United States, this one is the 712th largest by planned enrollment of the 842 interventional ones, is one of 26 that started in 2026, is one of 146 in phase 4, reaches primary completion later than 27 of the 82 other live ones, and was the 964th registered.

By phase

965 studies; the count open now beside each. This study's row is marked.

Phase 1177 · 11 open
Phase 2161 · 7 open
No phase160 · 13 open
Phase 4this study146 · 8 open
Observational122 · 14 open
Phase 3116 · 6 open
Phase 1/272 · 1 open
Phase 2/311 · 0 open

By the year they started

First in 1997; this study’s year is marked. 26 started in 2026.

Size and results

Median enrollment 273 across the 842 interventional studies, 261 across the 122 observational. Of the 841 that completed or were terminated, 433 (51%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 965 studies in Influenza, Human with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Healthy Adult Participants
  • Age 65 and Older
  • Age 18 to 40
  • Immunology

Browse trials for

Keywords

  • Influenza Vaccination
  • Rabies Vaccination
  • bone marrow plasma cells
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy participants 18 to 40 years of age or ≥65 years of age.
  2. Able to understand and give .
  3. Willing to receive RabAvert vaccine.
  4. Willing to receive TIV (trivalent influenza vaccine).
  5. In stable health, as determined by medical history and targeted physical exam related to this history.
  6. Willing to give blood and optional lymph node FNA (fine needle aspiration) samples.

Exclusion criteria

Exclusion Criteria:

  1. Has a history of severe local or systemic reactions to any vaccination.
  2. Has a history of severe allergic reaction to any component of the rabies or influenza vaccines.
  3. 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.
  4. Has received any influenza vaccines ≤ 180 days prior to the day of injection (Day 1).
  5. Has a current or previous diagnosis of immunocompromising condition to include , immune-mediated disease requiring treatment, or other immunosuppressive condition.
  6. Has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to Screening (for ≥ 10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
  12. 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.
  13. Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
  14. Unwilling to use an effective method of if you are of .
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Vaccination

    Standard, seasonal flu vaccine

    Biological: Trivalent inactivated influenza vaccine · Biological: RabAvert

Interventions

  • BiologicalTrivalent inactivated influenza vaccine

    Standard, seasonal flu vaccines

  • BiologicalRabAvert

    Rabies vaccine for pre-exposure

06

What researchers measure

Primary outcomes

  1. Rabies-specific antibody titers at day 29 compared to pre-vaccination baseline.

    Time frame: From vaccination day 1 to day 29

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Clinical study report

Time frame: Data will be deposited in the ImmPort shared data base, National Center for Biotechnology Information (NCBI), (GenBank, SRA, and dbGaP), MassIVE, PDB or EMDB data repositories. Each study deposited in ImmPort, PDB, and EMBD will be assigned a permanent digital object identifier (DOI) that will be cited in each publication. Each study or sequence(s) deposited in GenBank, SRA, or dbGaP will be assigned a permanent accession number that also will be cited in each publication. These persistent unique identifiers are searchable on Google and/or Pubmed. Each proteomic study deposited in MassIVE will be assigned a permanent ProteomeXchange accession that will be cited in each publication and is searchable on the MassIVE website. All of the data repositories to be used require rich metadata to be submitted along with each dataset to ensure that data is easy to find, access, and identify.

Access criteria: Data deposited on GenBank, SRA, MassIVE, PDB or EMDB will not be controlled and will be accessible for free download by the wider community. For data in ImmPort, users will need to register and agree to a Data Use Agreement prior to free download. Summaries of studies and the contents of measured variables deposited on dbGaP will be made public, while access to individual-level data will require authorization.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Feb 2027, 4 months after the start.

Of 101 non-industry phase 4 interventional studies under Influenza, Human, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 52. This study's planned 4 months is below that.

Counting every sponsor, half of 137 studies reached it within 14 months; a quarter within 3 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2026
First posted
Nov 3, 2026
StartActual
Sep 25, 2026
Primary completionEst.
Feb 1, 2027
CompletionEst.
Sep 25, 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07914673
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Sep 25, 2026
Primary completion
Feb 1, 2027 (estimated)
Completion
Sep 25, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Patrick Olson, MD
Contact
olsonp@wustl.edu
314-454-0058
Rachel Presti, MD
Contact
prestir@wustl.edu
314-454-0058

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: Rabies virus strain flury LEP antigen (propiolactone inactivated)

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