Status:
COMPLETED
Revealing Protective Immunity to Influenza Using Systems Immunology
Lead Sponsor:
Emory University
Collaborating Sponsors:
Boston University
Conditions:
Influenza
Eligibility:
All Genders
18-49 years
Phase:
PHASE4
Brief Summary
The goals of this study are to better understand the human immune response to influenza vaccines, specifically the live attenuated (weakened) influenza vaccine given as a nasal spray. Better understan...
Detailed Description
Influenza (flu) viruses cause significant disease and death every year. Influenza vaccines protect against illness but their effectiveness can be limited. The influenza virus is notorious for its cont...
Eligibility Criteria
Inclusion
- Able to understand and give informed consent
- Participants of child bearing potential must agree to use effective birth control for the duration of the study. A negative urine pregnancy test must be documented prior to vaccination.
Exclusion
- History of allergy or serious adverse reaction, including Guillain-Barré syndrome, to a vaccine or vaccine products
- History of a medical condition resulting in impaired immunity such as active solid tumors, leukemia, lymphoma, chemotherapy or radiation therapy, autoimmune conditions, or splenic dysfunction. Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
- History of asthma, cochlear implant, or active cerebrospinal fluid leak
- Use of immune modifying drugs including: systemic steroids for more than 1 week (such as prednisone \> 20mg/day), chronic administration (more than 14 days total) of immunosuppressive or immunomodulatory drugs in the prior 3 months
- History of HIV, Hepatitis B or Hepatitis C infection
- Chronic clinically significant medical problems that could be considered active or unstable (i.e diagnosed within the past 3 months or requiring a change in medication within the past 3 months). This is including (but not limited to):
- Insulin dependent diabetes
- Severe heart disease (including arrhythmias)
- Severe lung disease
- Severe liver disease
- Severe kidney disease
- Severe hypertension: defined as life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit).
- Congenital genetic syndromes (e.g., trisomy 21)
- Body Mass Index (BMI) \> 35
- Pregnancy or breast feeding, or plans to become pregnant in the next month
- History of influenza infection or vaccination within the current or previous influenza season
- Receipt of blood products or immune globulin product within the prior 3 months
- History of excessive alcohol consumption, drug use, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial
- Receipt of any live vaccines 30 days before, or plans to receive any live vaccines 30 days after vaccination
- Receipt of any inactivated vaccines 14 days before, or plans to receive any inactivated vaccines 14 days after vaccination
- Receipt of any non-registered or other investigational product in 30 days before, or plans to receive any other investigational product 30 days after vaccination
- Temporary
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06501963
Start Date
October 14 2024
End Date
April 1 2025
Last Update
November 6 2025
Active Locations (1)
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1
Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States, 30030