Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood (FLU-LN)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03898973|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : May 4, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Quadrivalent inactivated influenza vaccine (IIV)||Phase 4|
This is a Phase IV study of licensed influenza vaccines with up to 50 volunteers, 20-75 years of age.
Each volunteer will participate for approximately 1 week including enrollment, vaccination, and completion of sample collection.
The study has a total of 3 visits.
Screening Visit: Procedures during this visit are: Informed consent process, assess eligibility collect relevant clinical data and obtain 10 mL of blood to ensure the FNA will be safe (acceptable CBC and PT/PTT).
Visit 1: Vaccination Visit:
Eligible subjects will return and have a 20 mL blood sample. Participants will receive the inactivated flu vaccine into the right anterior quadriceps. Volunteers will be monitored for at least 15 minutes after study vaccination.
Visit 2: FNA Procedure: Seven days after vaccination the participant will return for another collection of 20 ml of blood and a fine needle aspiration of a right inguinal lymph node under ultrasound guidance by a trained pathologist.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Response to Inactivated Influenza Vaccine in Lymph Tissue and Blood|
|Actual Study Start Date :||April 11, 2019|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Participants will be given the current year's a quadrivalent inactivated influenza vaccine (IIV)
Biological: Quadrivalent inactivated influenza vaccine (IIV)
Intramuscular Injection. Participants will receive the inactivated flu vaccine into anterior quadriceps.
Other Name: Fluzone Quadrivalent
- HAI titer [ Time Frame: Day 7 after vaccination ]This measures response to influenza vaccine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||20 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 20-75-year-old male and female patients
- Body mass index (BMI) 20-35 kg/m2
- Acceptable laboratory values: Absolute neutrophil count (ANC) > 750 cells/mm3; Hemoglobin >10 g/dL; Platelet count >75,000/mm3; Partial thromboplastin time (PTT) >1.2x ULN; Prothrombin time (PT) >1.2x ULN
- Willing and able to complete the informed consent process
- Availability for follow-up for the planned duration of the study
- Acceptable medical history by review of inclusion/exclusion criteria
- Prior off-study vaccination with seasonal influenza vaccine within three months of study vaccination
- Life-threatening reactions to previous influenza vaccinations
- Allergy to egg or egg products or to vaccine components
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
- Known or suspected impairment of immunologic function; may include significant liver disease, diabetes mellitus treated with insulin or moderate to severe renal disease
- Chronic Hepatitis B or C.
- Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator.
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year
- Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg per day), Plavix, or Aggrenox will be reviewed by investigators to determine if study participation would affect the volunteer's safety or compliance with the protocol.
- Receipt of blood or blood products within the past 6 months or planned used during the study.
- A medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Receipt of an inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last annual study visit (~ 28 days after study vaccination)
- Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit (~ 28 days after study enrollment)
- Need for allergy immunization (that cannot be postponed) until after the last study visit.
- History of Guillain-Barre# syndrome
- Use of investigational agents within 30 days prior to enrollment or planned use during the study.
- Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or donation of platelets within 2 weeks of enrollment or planned donation prior to completion of the last visit.
- Any condition which, in the opinion of the investigator, might interfere with volunteer safety,
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898973
|Contact: Philip Grantemail@example.com|
|United States, California|
|Stanford University Medical Center, Lane building L134||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Philip M Grant, MD 650-723-9443 firstname.lastname@example.org|
|Responsible Party:||Philip Grant, Assistant Professor of Medicine (Infectious Diseases), Stanford University|
|Other Study ID Numbers:||
|First Posted:||April 2, 2019 Key Record Dates|
|Last Update Posted:||May 4, 2022|
|Last Verified:||May 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
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