10 Participants Needed

LAIV for Flu

(LAIV Trial)

AN
Overseen ByAnoma Nellore, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

AN

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

No history of allergy to IIV
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.
See 2 more

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Live Attenuated Influenza Vaccine (LAIV) and are monitored for immune response, followed by an intramuscular influenza vaccination

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood tests to assess T-bet expressing Flu-specific B cell subtypes

7 days

What Are the Treatments Tested in This Trial?

Interventions

  • Live Attenuated Flu Vaccine (LAIV)
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment GroupExperimental Treatment1 Intervention

Live Attenuated Flu Vaccine (LAIV) is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Flumist for:
🇪🇺
Approved in European Union as Fluenz Tetra for:
🇨🇦
Approved in Canada as Flumist Quadrivalent for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Published Research Related to This Trial

The live attenuated influenza vaccine (LAIV) is effective in protecting children aged ≤71 months against influenza, showing superior efficacy compared to the trivalent inactivated influenza vaccine (TIV) in several studies, particularly in younger children.
LAIV is generally well tolerated, with mild to moderate side effects, but it is not recommended for children under 24 months due to an increased risk of wheezing and hospitalization in this age group.
Live attenuated influenza vaccine (FluMist®; Fluenz™): a review of its use in the prevention of seasonal influenza in children and adults.Carter, NJ., Curran, MP.[2022]
In a study of 197 healthy children aged 9 to 36 months, 80% of those who received the live attenuated influenza vaccine (LAIV) shed at least one vaccine strain, indicating effective viral replication and immune response.
Despite high shedding rates, the probability of transmitting the vaccine strain to unvaccinated contacts was very low at 0.58%, and no significant safety concerns or adverse events were reported in either the vaccinated or placebo groups.
A randomized, double-blind study of the safety, transmissibility and phenotypic and genotypic stability of cold-adapted influenza virus vaccine.Vesikari, T., Karvonen, A., Korhonen, T., et al.[2011]
In a study involving 10,169 children and adolescents over four influenza seasons, the live attenuated influenza vaccine (LAIV) showed a vaccine effectiveness (VE) of 69% against influenza A(H1N1)pdm09, which is comparable to the 79% effectiveness of the inactivated influenza vaccine (IIV).
The study found no significant differences in effectiveness between LAIV and IIV for most influenza types, suggesting that both vaccines are effective options for preventing influenza in children aged 2 to 17 years.
Effectiveness of Live Attenuated vs Inactivated Influenza Vaccines in Children During the 2012-2013 Through 2015-2016 Influenza Seasons in Alberta, Canada: A Canadian Immunization Research Network (CIRN) Study.Buchan, SA., Booth, S., Scott, AN., et al.[2019]

Citations

Live attenuated influenza vaccine (FluMist®; Fluenz™): a review of its use in the prevention of seasonal influenza in children and adults. [2022]
A randomized, double-blind study of the safety, transmissibility and phenotypic and genotypic stability of cold-adapted influenza virus vaccine. [2011]
Effectiveness of Live Attenuated vs Inactivated Influenza Vaccines in Children During the 2012-2013 Through 2015-2016 Influenza Seasons in Alberta, Canada: A Canadian Immunization Research Network (CIRN) Study. [2019]
Current status of live attenuated influenza virus vaccine in the US. [2005]
Shedding and immunogenicity of live attenuated influenza vaccine virus in subjects 5-49 years of age. [2022]
Genetic stability of live, cold-adapted influenza virus components of the FluMist/CAIV-T vaccine throughout the manufacturing process. [2008]
Influenza vaccination for the pediatric patient: a focus on the new intranasal, cold-adapted, live attenuated vaccine. [2021]
A Single Mutation at PB1 Residue 319 Dramatically Increases the Safety of PR8 Live Attenuated Influenza Vaccine in a Murine Model without Compromising Vaccine Efficacy. [2021]
Live attenuated influenza vaccine (Fluenz™): a guide to its use in the prevention of seasonal influenza in children in the EU. [2021]
Safety, immunogenicity and infectivity of new live attenuated influenza vaccines. [2022]
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