LAIV for Flu
(LAIV Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
As yet the investigators do not understand if there are biomarkers of immune protection after the Flumist or Live Attenuated Flu Vaccine (LAIV). Here the investigators test the hypothesis that the T-bet expressing fraction of flu-specific B cells after live attenuated influenza vaccination also serves as an early biomarker of long-lived antibody responses after vaccination. In this study the investigators will be providing the LAIV to up to 10 healthy subjects and assaying their immune response and then providing the intramuscular influenza vaccination and testing to see if the immune protection after the LAIV also protects after the intramuscular influenza vaccination.Update: We have amended this protocol to study the antigen-specific B cell populations that circulate after LAIV or IIV prime and LAIV or IIV boost.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it requires participants to be healthy without an immunocompromising condition, which might imply that certain medications affecting the immune system could be excluded.
Is the Live Attenuated Influenza Vaccine (LAIV) safe for humans?
The Live Attenuated Influenza Vaccine (LAIV), also known as FluMist, is generally well tolerated in healthy individuals aged 5-49 years, with common mild side effects like runny nose, sore throat, and headache. It has been shown to be safe in various studies, although it may cause wheezing in some children and is not recommended for those at high risk.12345
How is the live attenuated flu vaccine (LAIV) different from other flu treatments?
The live attenuated flu vaccine (LAIV) is unique because it is administered as a nasal spray rather than an injection, and it contains weakened live viruses that help the body build immunity. This method can induce a broader immune response compared to inactivated vaccines, which are typically given as shots.13678
What data supports the effectiveness of the treatment Live Attenuated Flu Vaccine (LAIV), Flumist, Live Attenuated Influenza Vaccine?
Research shows that the Live Attenuated Influenza Vaccine (LAIV) is effective in preventing influenza in children, with studies indicating it is more effective than the inactivated vaccine in certain cases. It has also been shown to reduce the incidence of flu-related illnesses and work absenteeism in adults.138910
Who Is on the Research Team?
Anoma Nellore, MD
Principal Investigator
University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for healthy individuals who haven't had a flu vaccine in the past year and have no history of reactive airway disease or allergies to live or inactivated flu vaccines. They should not have an immunocompromising condition like cancer, autoimmune diseases, organ transplants, or be on steroids.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Live Attenuated Influenza Vaccine (LAIV) and are monitored for immune response, followed by an intramuscular influenza vaccination
Follow-up
Participants are monitored for safety and effectiveness after treatment, including blood tests to assess T-bet expressing Flu-specific B cell subtypes
What Are the Treatments Tested in This Trial?
Interventions
- Live Attenuated Flu Vaccine (LAIV)
Live Attenuated Flu Vaccine (LAIV) is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor