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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
Must not have
History of reactive airway disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days post second injection
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I consider myself healthy and do not have conditions like cancer, autoimmune diseases, or organ transplants.
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I have never had asthma or similar lung conditions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of asthma or similar lung conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days post second injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days post second injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,646 Previous Clinical Trials
2,342,366 Total Patients Enrolled
Anoma Nellore, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Live Attenuated Flu Vaccine (LAIV) (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04080245 — Phase < 1
Flu-Related Pain Research Study Groups: Treatment Group
Flu-Related Pain Clinical Trial 2023: Live Attenuated Flu Vaccine (LAIV) Highlights & Side Effects. Trial Name: NCT04080245 — Phase < 1
Live Attenuated Flu Vaccine (LAIV) (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04080245 — Phase < 1
~2 spots leftby Jun 2025
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