HealthyEarly Phase 1WU 345NCT07386509
WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza Vaccines in the Lymphoid Tissues.
A Early Phase 1 study testing Fluad® and Afluria® vaccination in people with Healthy, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fluad® and Afluria® vaccination
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2020to 4 Nov 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy subjects aged 18-49 years. 2. Able to understand and give informed consent. 3. Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods* for 28 days before and 28 days after rabies vaccination.
- Women of child-bearing potential using licensed hormonal methods must also use a second form of contraception.
- 4. Are in good health, as determined by medical history and targeted physical exam related to this history.
- 5. Willing to give FNA specimens for the study.
- 6. The following laboratory values obtained within 14 days prior to entry by any US laboratory that has a CLIA certification or its equivalent.
- Absolute neutrophil count (ANC) ≥750 cells/mm3
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- Hemoglobin ≥11.0 g/dL for men and ≥10.0 g/dL for women
- Platelet count ≥100,000/mm3
- Creatinine clearance ≥60 mL/min estimated by the Cockcroft-Gault equation
- NOTE: A program for calculating creatinine clearance by the Cockcroft-Gault method is available on www.fstrf.org
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) ≤5.0 times upper limit of normal (ULN)
- Erythrocyte sedimentation rate (ESR) within normal range
Who cannot join
- 1. Receipt of the following:
- Receipt of blood products 3 months prior to vaccination or expected receipt through 12 months after vaccination.
- Receipt of any live virus vaccines within 28 days prior to vaccination or expected receipt within 28 days after vaccination. *
- Receipt of any inactivated vaccine within 14 days or expected receipt within 14 days after vaccination other than study vaccine. * 2. Presence of co-morbidities or immunosuppressive states such as: Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease (including arrhythmias), severe lung disease, auto immune diseases, thrombocytopenia and any other severe medical conditions.
- 3. Alcohol abuse, drug abuse, or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
- 4. Any history of lymphoma involving axillary nodes or any history of breast cancer.
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- 5. Impaired immune function or known chronic infections including, but not limited to, known HIV, tuberculosis, hepatitis B or C; organ transplantation (bone marrow, hematopoietic stem cell, or solid organ transplant); immunosuppression due to cancer; current and/or expected receipt of chemotherapy, radiation therapy, steroids (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days , or high dose inhaled corticosteroids); and any other immunosuppressive therapies (including anti-TNF therapy), functional or anatomic asplenia, or congenital immunodeficiency.
- 6. Pregnancy or breast feeding 7. Conditions that could affect the safety of the volunteers, such as:
- Severe reactions to prior vaccinations, including anaphylaxis
- History of Guillain-Barré syndrome
- History of bleeding disorders or current use of warfarin, aspirin, heparin, nonsteroidal anti-inflammatory drugs (NSAIDs) or other blood thinner/anticoagulant medications in the past week
- Any allergy to any component of the vaccine or lidocaine 8. Subjects with any acute illness, including any fever (> 100.4 F [>38.0C], regardless of the route) within 3 days prior to vaccination *.
- 9. Social, occupational, or any other condition that in the opinion of the investigator might interfere with compliance with the study and vaccine evaluation.
- 10. ESR>30 mm/hour. 11. Previously received the 2019-2020 influenza vaccine. 12. Bilateral inflammatory process of upper arms in the past 2 weeks. 13. Prior breast or axillary biopsy and/or surgery.
- Notes:
- An individual who initially is excluded from study participation based on one or more of the time-limited exclusion criteria (e.g., acute illness, receipt or expected receipt of live or inactivated vaccines) may be reconsidered for enrollment once the condition has resolved as long as the subject continues to meet all other entry criteria.
- Subjects receiving > 20 mg/day of prednisone or its equivalent daily or on alternate days for more than 2 weeks may enter the study after therapy has been discontinued for more than 3 months.
- Subjects are excluded if on high dose intranasal steroids defined as > 960 mcg/day of beclomethasone dipropionate or equivalent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine Infectious Disease Clinical Trials Unit.
St Louis, Missouri, 63110
About this study
Official title: WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza
Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles. Blood samples collected at 9 visits (screening, baseline, days 7, 14, 28, 60, 90, 120 and 180, fine needle aspiration (FNAs) from axillary lymph nodes from both axillae at baseline, days 7, 14, 28, 60, 90, 120 and 180.
Read the detailed description
Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles. Blood samples collected at 9 visits (screening, baseline, days 7, 14, 28, 60, 90, 120 and 180, fine needle aspiration (FNAs) from axillary lymph nodes from both axillae at baseline, days 7, 14, 28, 60, 90, 120 and 180.
- Conditions
- Healthy
- Being tested
- Fluad® and Afluria® vaccination
- Keywords
- immunue response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluad® and Afluria® vaccinationDrug
All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles
| Study group | Role | What they receive |
|---|---|---|
| Single dose of both Fluad® and Afluria® | Experimental | All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly Receives: Drug: Fluad® and Afluria® vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of antibody titers at Day 28 versus baseline
Measured: Baseline and Day 28
Secondary outcomes (1)
Frequency, severity, and causality of all adverse events.
Measured: Baseline and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start17 Mar 2020
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Why it stopped: COVID pandemic No participant experiences (benefits, adverse events/adverse reactions)to report. There have been no safety concerns in either participant. No minor deviations to report
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Presti, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386509
- Sponsor's protocol ID
- 201912144
- Acronym
- WU 345
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WU 345: Immune Responses to Adjuvanted and Non-adjuvanted Seasonal Influenza
- ClinicalTrials.gov ID
- NCT07386509
- Acronym / sponsor ID
- WU 345 / 201912144
- Conditions
- Healthy
- Keywords
- immunue response
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID pandemic No participant experiences (benefits, adverse events/adverse reactions)to report. There have been no safety concerns in either participant. No minor deviations to report
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 4 Feb 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.
Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles. Blood samples collected at 9 visits (screening, baseline, days 7, 14, 28, 60, 90, 120 and 180, fine needle aspiration (FNAs) from axillary lymph nodes from both axillae at baseline, days 7, 14, 28, 60, 90, 120 and 180.
Detailed description
Healthy adults (18-49 years of age) with no previous influenza virus vaccination history for at least three years prior to enrollment will be recruited to participate in this study. All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles. Blood samples collected at 9 visits (screening, baseline, days 7, 14, 28, 60, 90, 120 and 180, fine needle aspiration (FNAs) from axillary lymph nodes from both axillae at baseline, days 7, 14, 28, 60, 90, 120 and 180.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles.
| Arm | Type | Receives |
|---|---|---|
| Single dose of both Fluad® and Afluria® | Experimental | Drug: Fluad® and Afluria® vaccinationAll subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 1. Healthy subjects aged 18-49 years. 2. Able to understand and give informed consent. 3. Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods* for 28 days before and 28 days after rabies vaccination.
- 4. Are in good health, as determined by medical history and targeted physical exam related to this history.
- 5. Willing to give FNA specimens for the study.
- 6. The following laboratory values obtained within 14 days prior to entry by any US laboratory that has a CLIA certification or its equivalent.
Key exclusion criteria (18 listed)
- 1. Receipt of the following:
- 3. Alcohol abuse, drug abuse, or psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data.
- 4. Any history of lymphoma involving axillary nodes or any history of breast cancer.
- 5. Impaired immune function or known chronic infections including, but not limited to, known HIV, tuberculosis, hepatitis B or C; organ transplantation (bone marrow, hematopoietic stem cell, or solid organ transplant); immunosuppression due to cancer; current and/or expected receipt of chemotherapy, radiation therapy, steroids (i.e., more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 90 days , or high dose inhaled corticosteroids); and any other immunosuppressive therapies (including anti-TNF therapy), functional or anatomic asplenia, or congenital immunodeficiency.
- 6. Pregnancy or breast feeding 7. Conditions that could affect the safety of the volunteers, such as:
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 |
|---|---|---|
| Fluad® and Afluria® vaccinationAll subjects will concomitantly receive a single dose of both Fluad® and Afluria® administered intramuscularly in opposite deltoid muscles | Drug | Single dose of both Fluad® and Afluria® |
Primary outcome
Comparison of antibody titers at Day 28 versus baseline
Time frame: Baseline and Day 28
1 secondary outcome
Frequency, severity, and causality of all adverse events.
Time frame: Baseline and Day 28
Results and safety
The study was stopped early (reason given: COVID pandemic No participant experiences (benefits, adverse events/adverse reactions)to report. There have been no safety concerns in either participant. No minor deviations to report). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Rachel Presti, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluad® and Afluria® vaccination in people with Healthy, 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 12 inclusion and 18 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: stopped early, as of the sponsor's last update on 4 Feb 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID pandemic No participant experiences (benefits, adverse events/adverse reactions)to report. There have been no safety concerns in either participant. No minor deviations to report). Results are not available in the source record.
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?
Comparison of antibody titers at Day 28 versus baseline (time frame: Baseline and Day 28). 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 4 Feb 2026.