25 Participants Needed

Live Attenuated Influenza Vaccine for Flu

DL
Overseen ByDavid LaFon, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immune-suppressing medications, you may not be eligible to participate.

What data supports the effectiveness of the drug FluMist Quadrivalent Nasal Product for preventing the flu?

Clinical trials have shown that the live attenuated influenza vaccine (FluMist) is effective in preventing influenza, with a protective efficacy of 92% in young children and significant protection against strains not contained in the vaccine. It is well tolerated in healthy individuals aged 5-49 years and offers a convenient intranasal administration without the need for injections.12345

Is the live attenuated influenza vaccine (FluMist) safe for humans?

FluMist, a live attenuated influenza vaccine, is generally well tolerated in healthy individuals aged 5-49 years, with common side effects including mild symptoms like cough and sore throat. Studies have shown it to be safe, with no transmission detected to close contacts, and it has been safely tested in immunocompromised ferrets, suggesting potential safety in similar human populations.12567

What makes the FluMist Quadrivalent Nasal Product unique compared to other flu treatments?

FluMist Quadrivalent is unique because it is a nasal spray vaccine that contains live, weakened viruses, unlike most flu vaccines which are injections with inactivated (killed) viruses. It also covers four strains of the flu virus, including both B lineages, reducing the risk of mismatch with circulating strains.89101112

What is the purpose of this trial?

The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses. In a subset of participants, cystic fibrosis transmembrane conductance regulator (CFTR) function will also be evaluated via measurement of nasal potential difference (NPD)

Eligibility Criteria

Healthy adults aged 18-49 who haven't had the flu vaccine for the current season can join. They must be able to consent to participate. People with chronic health issues, recent respiratory infections, heart failure, Guillain-Barre syndrome, pregnancy, egg allergies or contact with immunocompromised individuals cannot join.

Inclusion Criteria

I have not received the flu vaccine for 2019-2020.
I am able to understand and sign the consent form.
I have not received the flu vaccine for 2019-2020.
See 1 more

Exclusion Criteria

You have smoked cigarettes in the last 6 months.
I have a heart condition other than just high blood pressure.
I have asthma.
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the live attenuated influenza vaccine (LAIV) to simulate influenza infection

1 day
1 visit (in-person)

Follow-up

Participants are monitored for influenza virus replication and inflammatory response

2 days
1 visit (in-person)

Treatment Details

Interventions

  • Flumist Quadrivalent Nasal Product
Trial Overview The study is testing a nasal spray flu vaccine called Flumist Quadrivalent to develop a model of influenza infection. Participants will receive this live vaccine and researchers will collect nasal samples to study virus presence and immune responses.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: open labelExperimental Treatment1 Intervention
FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer

Flumist Quadrivalent Nasal Product is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as FluMist Quadrivalent for:
  • Prevention of influenza A and B viruses in individuals aged 2 through 49 years
🇪🇺
Approved in European Union as Fluenz Tetra for:
  • Prevention of influenza A and B viruses in individuals aged 2 through 49 years
🇨🇦
Approved in Canada as FluMist for:
  • Prevention of influenza A and B viruses in individuals aged 2 through 49 years
🇯🇵
Approved in Japan as FluMist for:
  • Prevention of influenza A and B viruses in individuals aged 2 through 49 years

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+

Findings from Research

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]
FluMist is an effective intranasal vaccine for preventing influenza A and B, showing good tolerance in healthy individuals aged 5-49 years based on clinical trials.
The vaccine offers a painless alternative to traditional injections, although barriers such as patient eligibility, cost, and insurance coverage may affect its acceptance.
Influenza vaccination for the pediatric patient: a focus on the new intranasal, cold-adapted, live attenuated vaccine.Ellis, JM., Reilly, JC., Salazar, JC.[2021]
The cold adapted live attenuated influenza vaccine (CAIV-T, FluMist) has shown a high protective efficacy of 92% against culture-confirmed influenza in young children over a two-year study, demonstrating its effectiveness as a preventive measure.
In adults, CAIV-T not only induced a broad immune response even when the vaccine strain did not match the epidemic strain but also effectively reduced febrile upper respiratory illnesses and days missed from work, highlighting its overall effectiveness in real-world settings.
Current status of live attenuated influenza virus vaccine in the US.Belshe, RB.[2005]

References

A randomized, double-blind study of the safety, transmissibility and phenotypic and genotypic stability of cold-adapted influenza virus vaccine. [2011]
Influenza vaccination for the pediatric patient: a focus on the new intranasal, cold-adapted, live attenuated vaccine. [2021]
Current status of live attenuated influenza virus vaccine in the US. [2005]
Live attenuated influenza vaccine (Fluenz™): a guide to its use in the prevention of seasonal influenza in children in the EU. [2021]
Update: ACIP Recommendations for the Use of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) - United States, 2018-19 Influenza Season. [2019]
Live attenuated influenza vaccine is safe and immunogenic in immunocompromised ferrets. [2013]
Evaluation of a candidate live attenuated influenza vaccine prepared in Changchun BCHT (China) for safety and efficacy in ferrets. [2018]
Influenza vaccination. [2019]
Effect of a short training on neonatal face-mask ventilation performance in a low resource setting. [2018]
Effectiveness of the 2010 and 2011 Southern Hemisphere trivalent inactivated influenza vaccines against hospitalization with influenza-associated acute respiratory infection among Thai adults aged ≥ 50 years. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Pharmacy provision of influenza vaccinations in medically underserved communities. [2012]
Retrospective public health impact of a quadrivalent influenza vaccine in the United States. [2018]
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