Live Attenuated Influenza Vaccine for Flu
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Immune suppressing medications
Disqualifiers: Immunocompromising, Asthma, Diabetes, Pregnancy, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
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)
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.12367
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
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 am between 18 and 49 years old.
I have not received the flu vaccine for 2019-2020.
I am able to understand and sign the consent form.
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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
Trial 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 (Virus Therapy)
Trial OverviewThe 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
Research Locations NearbySelect from list below to view details:
UAB Lung Health CenterBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
References
Influenza vaccination for the pediatric patient: a focus on the new intranasal, cold-adapted, live attenuated vaccine. [2021]FluMist is the first live attenuated, cold-adapted intranasal influenza vaccine (LAIV) approved for the prevention of influenza A and B. Clinical trials have shown that annual vaccination with LAIV is effective for the prevention of influenza. LAIV appears well tolerated in healthy patients 5-49 years of age. The most common adverse events are abdominal pain, chills, cough, diarrhea, headache, irritability, lethargy, muscle aches, otitis media, rhinitis, sinusitis, sore throat, and vomiting. FluMist has a novel intranasal route of administration that allows for influenza prevention without a painful intramuscular injection. Barriers preventing acceptance of LAIV include defining the appropriate patient population, cost, and insurance coverage.
Update: ACIP Recommendations for the Use of Quadrivalent Live Attenuated Influenza Vaccine (LAIV4) - United States, 2018-19 Influenza Season. [2019]Intranasally administered live attenuated influenza vaccine (LAIV) was initially licensed in the United States in 2003 as a trivalent formulation (LAIV3) (FluMist, MedImmune, LLC). Quadrivalent live attenuated influenza vaccine (LAIV4) (FluMist Quadrivalent, MedImmune) has been licensed in the United States since 2012 and was first available during the 2013-14 influenza season, replacing LAIV3. During the 2016-17 and 2017-18 influenza seasons, the Advisory Committee on Immunization Practices (ACIP) recommended that LAIV4 not be used because of concerns about low effectiveness against influenza A(H1N1)pdm09-like viruses circulating in the United States during the 2013-14 and 2015-16 seasons (1,2). On February 21, 2018, ACIP recommended that LAIV4 be an option for influenza vaccination of persons for whom it is appropriate for the 2018-19 season (3). This document provides an overview of the information discussed in the decision-making process leading to this recommendation. A description of methodology and data reviewed will be included in the background materials that will supplement the 2018-19 ACIP Influenza Recommendations, which will replace the 2017-18 ACIP influenza statement (2), and which will also contain guidance for the use of LAIV4.
A randomized, double-blind study of the safety, transmissibility and phenotypic and genotypic stability of cold-adapted influenza virus vaccine. [2011]Live attenuated influenza vaccine (LAIV; FluMist) is a trivalent vaccine containing cold-adapted influenza vaccine viruses that infect and replicate in cells lining the nasopharynx to induce immunity. Recovery of viruses (shedding) is measured by culture of nasal specimens. Shedding of vaccine viruses is not equated with transmission because transmission requires more virus than is detected in many nasal swabs. Previous studies with LAIV did not detect transmission to close contacts. The primary objective of this study was to estimate the probability of transmission to placebo contacts in a day care setting.
Current status of live attenuated influenza virus vaccine in the US. [2005]The efficacy and effectiveness of cold adapted live attenuated (CAIV-T, FluMist intranasal influenza vaccine is reviewed. CAIV-T consists of approximately 10(7) TCID50 per dose of each influenza A/H1N1, influenza A/H3N2, and influenza B vaccine strain. The exact strains are updated each year to antigenically match the antigens recommended by national health authorities for inclusion in the vaccine. In one year in which the vaccine strain did not well match the epidemic strain, the live attenuated vaccine induced a broad immune response that cross-reacted significantly with the drifted strain. The efficacy of CAIV-T in adults was demonstrated with challenge studies and the effectiveness of the vaccine for reducing febrile upper respiratory illness, days of missed work, and days of antibiotic use was demonstrated in a large field trial. In young children, protective efficacy against culture confirmed influenza was demonstrated in a field trial with overall protective efficacy of 92% during a two year study. Vaccine was also highly protective against a strain not contained in the vaccine, with 86% protective efficacy demonstrated against this significantly drifted virus. Effectiveness measures, including protection against febrile otitis media and visits to the doctor were demonstrated. Live attenuated vaccine provides a significant new tool to help prevent influenza.
Live attenuated influenza vaccine (Fluenz™): a guide to its use in the prevention of seasonal influenza in children in the EU. [2021]Live attenuated influenza vaccine (LAIV).[Fluenz™] has a convenient intranasal route of administration. In the EU, it is indicated for the prevention of influenza disease caused by the influenza virus strains contained in the vaccine in children and adolescents aged 2 years to
Live attenuated influenza vaccine is safe and immunogenic in immunocompromised ferrets. [2013]Patients undergoing chemotherapy for cancer are highly susceptible to influenza virus infection. Prevention of influenza virus infection is complicated in the immunocompromised host because of suboptimal responses to the trivalent inactivated influenza vaccine (TIV). A new, live attenuated influenza vaccine (LAIV; FluMist) may offer a more effective alternative to TIV, but the safety of this LAIV in immunocompromised patients must first be established. In the present study, FluMist was administered to ferrets immunocompromised by treatment with dexamethasone and cytarabine. Ferrets exhibited no signs or symptoms attributable to FluMist, and nasal clearance of LAIV strains from immunocompromised ferrets was similar to that from control ferrets. Serum antibody responses against the vaccinating strains were analyzed as a measure of vaccine efficacy. Antibody titers to all 3 vaccine strains in immunocompromised ferrets were similar to those seen in mock-treated control ferrets, as assessed by microneutralization assay. These findings support the potential use of this vaccine in immunocompromised humans.
Evaluation of a candidate live attenuated influenza vaccine prepared in Changchun BCHT (China) for safety and efficacy in ferrets. [2018]We evaluated the safety and efficacy of a live attenuated influenza vaccine (LAIV) product in ferrets. The BCHT LAIV product was significantly less virulent than wild-type H1N1 virus, when evaluated by comparing virus shedding and histopathologic lesions. The data indicated strong evidence for an attenuated phenotype of LAIV. Furthermore, the vaccine induced robust humoral immune responses in seronegative ferrets, and protected ferrets against development of fever, weight loss and turbinate inflammatory lesions after challenging with H3N2 wide-type influenza virus. Thus, the BCHT LAIV product was safe in healthy seronegative ferrets and protected ferrets against infection of H3N2 influenza virus.
Influenza vaccination. [2019]The availability of influenza vaccines brings relief to high-risk categories. For trained and competent nurses this means carrying out an audit of high-risk people and ordering sufficient doses in the spring and summer, and then administering vaccines to this group in the autumn.
Effect of a short training on neonatal face-mask ventilation performance in a low resource setting. [2018]We assessed whether a short training, effective in a high resource country, was able to improve the quality of face-mask ventilation (FMV) in a low resource setting.
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]Inactivated influenza vaccine (IIV) effectiveness has been evaluated among older adults in high-income countries, but data on IIV effectiveness in low- and middle-income countries remain sparse. We conducted a test-negative case-control analysis to estimate 2010 and 2011 trivalent IIV effectiveness against hospitalization with influenza-associated acute respiratory infection (ARI) among persons aged ≥ 50 years in rural Thailand.
Pharmacy provision of influenza vaccinations in medically underserved communities. [2012]To demonstrate the extent to which a community pharmacy can provide influenza immunizations in communities designated as medically underserved.
Retrospective public health impact of a quadrivalent influenza vaccine in the United States. [2018]Vaccination is an effective preventive strategy against influenza. However, current trivalent influenza vaccines (TIVs) contain only one of the two influenza B lineages that circulate each year. Vaccine mismatches are frequent because predicting which one will predominate is difficult. Recently licensed quadrivalent influenza vaccines (QIVs) containing the two B lineages should address this issue. Our study estimates their impact by assessing what would have been the US public health benefit of routinely vaccinating with QIV in 2000-2013.