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Virus Therapy
LAIV for Flu (LAIV Trial)
Phase < 1
Recruiting
Led By Anoma Nellore, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-identify as healthy without an immunocompromising condition defined as cancer, autoimmune disease, organ transplant or receipt of steroids.
No history of reactive airway disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days post second injection
Awards & highlights
LAIV Trial Summary
This trial is testing the hypothesis that the T-bet expressing fraction of flu-specific B cells after receiving the live attenuated influenza vaccine (LAIV) serves as an early biomarker of long-lived antibody responses after vaccination.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if T-bet expressing B cells after receiving the Live Attenuated Flu Vaccine (LAIV) can predict long-lasting antibody responses. Participants will first receive LAIV and then the intramuscular flu vaccine to assess immune protection from both vaccinations.See study design
What are the potential side effects?
While specific side effects are not listed for this trial, common reactions to LAIV may include nasal congestion, runny nose, sore throat, and possibly fever.
LAIV Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I consider myself healthy and do not have conditions like cancer, autoimmune diseases, or organ transplants.
Select...
I have never had asthma or similar lung conditions.
LAIV Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days post second injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days post second injection
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
LAIV Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,593 Previous Clinical Trials
2,282,664 Total Patients Enrolled
Anoma Nellore, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot consider yourself to be in good health.You have had an allergic reaction to the live attenuated influenza vaccine (LAIV) or the inactivated influenza vaccine (IIV).I have a history of asthma or similar lung conditions.I consider myself healthy and do not have conditions like cancer, autoimmune diseases, or organ transplants.You did not get the flu shot last year.I have never had asthma or similar lung conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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