Immunity, CellularEarly Phase 1NCT03748524
Analysis of Antigen Specific B Cell Responses to Immunization With Influenza Virus Vaccine
A Early Phase 1 study testing Influenza Vaccine in people with Immunity, Cellular, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Immunization with the inactivated influenza vaccine with blood samples collected at 7 visits (baseline, day 7, 14, 28, 60, 90 and 180, fine needle aspiration (FNAs) from axillary lymph nodes at baseline, days, 4, 14, 28, 60 and 180. BMA at baseline, days 28 and 180. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunity, Cellular
- What is being tested?
- Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 20 Jun 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and give informed consent
- Capable of attending all study visits according to the study schedule.
- Males or females between the ages of 18 to 50 (inclusive).
- Are in good health, as determined by medical history and targeted physical exam related to this history.
- Participants agree not to take any vaccines in the first 60 days after receipt of the influenza vaccine
- The following laboratory values obtained within 14 days prior to entry..
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- Absolute neutrophil count (ANC) ≥750 cells/mm3
- 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
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (SGPT) ≤5.0 times upper limit of normal (ULN)
- Willing to:
- give FNA specimens for the study. (even if he/she are not willing to give bone marrow aspirates (for any reason), they can be enrolled)
- give bone marrow aspirates, but we cannot locate axillary lymph nodes
- give both FNA and BMA specimens
Who cannot join
- 1. History influenza vaccination for the last three years.
- 2. Coagulopathy (primary or iatrogenic) which would contraindicate FNA
- 3. Any history of allergy to eggs, chicken or gelatin or to any previous influenza vaccine
- 4. Have an acute illness within 72 hours before vaccination.
- 5. A history of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
- 6. History of HIV infection, Hepatitis B or Hepatitis C infection
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- 7. History of any chronic medical conditions that are considered progressive (ex, diabetes, heart disease, lung disease, liver disease, kidney disease, gastrointestinal diseases and uncontrolled hypertension).
- 8. 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.
- 9. Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination.
- 10. Have taken high-dose inhaled corticosteroids within 30 days before study vaccination.
- 11. Autoimmune disorders; mild autoimmune disorders such as eczema is not exclusion after assessment by the investigator.
- 12. Recipient of a blood products or immune globulin product within 42 days of the vaccination visit.
- 13. Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
- 14. Have received any licensed live vaccine within 30 days or any licensed inactivated vaccine within 14 days prior to study vaccination.
- 15. Have planned vaccination with any vaccine during first 60 days of study participation.
- 16. Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination.
- 17. Have donated blood or blood products within 30 days before study vaccination, plan to donate blood at any time during the duration of subject study participation, or plan to donate blood within 30 days after the last blood draw.
- 18. Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
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
Official title: Washington University (WU) 321: Analysis of Antigen Specific B Cell Responses to Immunization With Influenza Virus Vaccine: Fine Needle Aspiration (FNA) and Bone Marrow Aspiration (BMA)
Immunization with the inactivated influenza vaccine with blood samples collected at 7 visits (baseline, day 7, 14, 28, 60, 90 and 180, fine needle aspiration (FNAs) from axillary lymph nodes at baseline, days, 4, 14, 28, 60 and 180. BMA at baseline, days 28 and 180.
Read the detailed description
IM Immunization with the inactivated influenza vaccine with blood samples collected at 7 visits (baseline, day 7, 14, 28, 60, 90 and 180, fine needle aspiration (FNAs) from axillary lymph nodes at baseline, days, 4, 14, 28, 60 and 180. BMA at baseline, days 28 and 180.
- Conditions
- Immunity, Cellular
- Being tested
- Influenza Vaccine
- Keywords
- Influenza, B cells, Antibodies, Vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza VaccineDrug
Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0
| Study group | Role | What they receive |
|---|---|---|
| Single Influenza Vaccine | Experimental | Single Influenza Vaccine,Quadrivalent Receives: Drug: Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the percentage of subjects achieving seroconversion
Change in serum hemagglutination-inhibition (HAI) antibody titers between day 0 to day 28
Measured: 0 and day 28
Secondary outcomes (1)
Determine the frequency of vaccine-induced responses
Frequency of vaccine-specific plasmablasts detected in blood at day 7 after vaccination
Measured: Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start29 Oct 2018
- Primary completion30 Sep 2021
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunity, CellularStudies 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Ellebedy, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748524
- Sponsor's protocol ID
- 201808171
- Status last verified
- Jan 2025
- First submitted
- 15 Nov 2018
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Washington University (WU) 321: Analysis of Antigen Specific B Cell Responses to Immunization With Influenza Virus Vaccine: Fine Needle Aspiration (FNA) and Bone Marrow Aspiration (BMA)
- ClinicalTrials.gov ID
- NCT03748524
- Acronym / sponsor ID
- 201808171
- Conditions
- Immunity, Cellular
- Keywords
- Influenza, B cells, Antibodies, Vaccination
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 21 Nov 2018 (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.
Immunization with the inactivated influenza vaccine with blood samples collected at 7 visits (baseline, day 7, 14, 28, 60, 90 and 180, fine needle aspiration (FNAs) from axillary lymph nodes at baseline, days, 4, 14, 28, 60 and 180. BMA at baseline, days 28 and 180.
Detailed description
IM Immunization with the inactivated influenza vaccine with blood samples collected at 7 visits (baseline, day 7, 14, 28, 60, 90 and 180, fine needle aspiration (FNAs) from axillary lymph nodes at baseline, days, 4, 14, 28, 60 and 180. BMA at baseline, days 28 and 180.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Influenza Vaccine | Experimental | Drug: Influenza VaccineSingle Influenza Vaccine,Quadrivalent |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Able to understand and give informed consent
- Capable of attending all study visits according to the study schedule.
- Males or females between the ages of 18 to 50 (inclusive).
- Are in good health, as determined by medical history and targeted physical exam related to this history.
- Participants agree not to take any vaccines in the first 60 days after receipt of the influenza vaccine
Key exclusion criteria (18 listed)
- 1. History influenza vaccination for the last three years.
- 2. Coagulopathy (primary or iatrogenic) which would contraindicate FNA
- 3. Any history of allergy to eggs, chicken or gelatin or to any previous influenza vaccine
- 4. Have an acute illness within 72 hours before vaccination.
- 5. A history of a medical condition resulting in impaired immunity (such as HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
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 |
|---|---|---|
| Influenza VaccineInfluenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0 | Drug | Single Influenza Vaccine |
Primary outcome
Determine the percentage of subjects achieving seroconversion
Time frame: 0 and day 28
Change in serum hemagglutination-inhibition (HAI) antibody titers between day 0 to day 28
1 secondary outcome
Determine the frequency of vaccine-induced responses
Time frame: Day7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Ali Ellebedy, PhD 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 Influenza Vaccine in people with Immunity, Cellular, 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 15 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: finished, as of the sponsor's last update on 13 Jan 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine the percentage of subjects achieving seroconversion (time frame: 0 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 13 Jan 2025.