InfluenzaPhase 4NCT04164212
Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection
A Phase 4 study testing Flumist Quadrivalent Nasal Product in people with Influenza, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Flumist Quadrivalent Nasal Product
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 22 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ages 18-49 years old,
- not yet received influenza vaccine for 2019-2020, and
- capable of giving signed informed consent.
Who cannot join
- Immunocompromising condition (e.g. HIV/AIDS, chemotherapy, immune suppressing medications),
- active smoking within past 6 months,
- asthma, chronic lung/liver/kidney /neurologic/hematologic/metabolic disorders,cardiovascular disease (excluding isolated hypertension), diabetes mellitus, disease, congestive heart failure,
- pregnancy,
- current or recent (within the past month) upper/lower respiratory tract infection, chronic sinusitis/nasal allergies requiring frequent or daily therapy (including topical corticosteroids),
- prior adverse reaction to influenza vaccine,
Show all 9Show fewer
- history of Guillain-Barre syndrome,
- egg allergy,
- close contact with an individual with severe immunodeficiency/immunosuppression.
Trial locations and contacts
1 site in 1 country.
About this study
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)
- Conditions
- Influenza
- Being tested
- Flumist Quadrivalent Nasal Product
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flumist Quadrivalent Nasal ProductDrug
Also called live attenuated influenza vaccine
FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer
| Study group | Role | What they receive |
|---|---|---|
| open label | Other | FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer Receives: Drug: Flumist Quadrivalent Nasal Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
influenza virus replication
virus replication will be measured using RT-PCR and reported as genomic units, from samples obtained from nasal washing and nasal oropharyngeal swabs
Measured: day 2
markers of inflammation
a standard panel of inflammatory cytokines (Luminex Performance Human XL Cytokine Discovery Panel assay, R\&D Systems; results reported in pg/ml) will be measured in samples obtained from nasal washing and nasal oropharyngeal swabs
Measured: change in inflammatory cytokines from baseline to day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Sep 2020
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David Lafon, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164212
- Sponsor's protocol ID
- IRB-300004274
- Other IDs
- R01HL149944
- Status last verified
- Feb 2026
- First submitted
- 7 Nov 2019
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Earnhardt EY, Tipper JL, Hanafy MA, Lazrak A, Lopez A, Perritt SE, LaFon DC, Mobley JA, Solomon GM, Harrod KS. Endoplasmic Reticulum Stress Disrupts the Airway Epithelium and Reduces Host Defense during Influenza A Virus Infection. Am J Respir Cell Mol Biol. 2026 Jan 1;74(1):40-51. doi: 10.1165/rcmb.2025-0141OC.
PubMed 40720746
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection
- ClinicalTrials.gov ID
- NCT04164212
- Acronym / sponsor ID
- IRB-300004274
- Conditions
- Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Other | Drug: Flumist Quadrivalent Nasal ProductFLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ages 18-49 years old,
- not yet received influenza vaccine for 2019-2020, and
- capable of giving signed informed consent.
Key exclusion criteria (9 listed)
- Immunocompromising condition (e.g. HIV/AIDS, chemotherapy, immune suppressing medications),
- active smoking within past 6 months,
- asthma, chronic lung/liver/kidney /neurologic/hematologic/metabolic disorders,cardiovascular disease (excluding isolated hypertension), diabetes mellitus, disease, congestive heart failure,
- pregnancy,
- current or recent (within the past month) upper/lower respiratory tract infection, chronic sinusitis/nasal allergies requiring frequent or daily therapy (including topical corticosteroids),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flumist Quadrivalent Nasal ProductAlso: live attenuated influenza vaccineFLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer | Drug | open label |
Primary outcome
influenza virus replication
Time frame: day 2
virus replication will be measured using RT-PCR and reported as genomic units, from samples obtained from nasal washing and nasal oropharyngeal swabs
markers of inflammation
Time frame: change in inflammatory cytokines from baseline to day 2
a standard panel of inflammatory cytokines (Luminex Performance Human XL Cytokine Discovery Panel assay, R\&D Systems; results reported in pg/ml) will be measured in samples obtained from nasal washing and nasal oropharyngeal swabs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 40720746Earnhardt EY, Tipper JL, Hanafy MA, Lazrak A, Lopez A, Perritt SE, LaFon DC, Mobley JA, Solomon GM, Harrod KS. Endoplasmic Reticulum Stress Disrupts the Airway Epithelium and Reduces Host Defense during Influenza A Virus Infection. Am J Respir Cell Mol Biol. 2026 Jan 1;74(1):40-51. doi: 10.1165/rcmb.2025-0141OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flumist Quadrivalent Nasal Product in people with Influenza, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
influenza virus replication (time frame: day 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.