Mucosal Immune Response to Influenza VaccinationPhase 4MOSAICNCT07726862
How Healthy Adults Respond to the Nasal Flu Vaccine
A Phase 4 study testing FluMist (Live Attenuated Influenza Vaccine) in people with Mucosal Immune Response to Influenza Vaccination, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study is looking at how the immune system in the nose responds after receiving the FluMist nasal flu vaccine in healthy adults. FluMist is an FDA-approved influenza vaccine that is given as a nasal spray. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mucosal Immune Response to Influenza Vaccination
- What is being tested?
- FluMist (Live Attenuated Influenza Vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Jun 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 18 to 65 years
- Non-smokers (no smoking or vaping within the past 6 months)
- No chronic lung disease or significant chronic medical conditions
- No current or recent (within 1 month) upper or lower respiratory infection
- Able and willing to provide informed consent
- Have not received the current seasonal influenza vaccine
- Able to comply with study procedures and follow-up visits
Who cannot join
- Age under 18 or over 65 years
- Pregnancy or breastfeeding
- Prisoners
- Non-English speaking individuals
- Immunocompromised individuals (including HIV/AIDS, immunosuppressive therapy, chemotherapy, or primary immunodeficiency)
- Chronic medical conditions including asthma, chronic lung, liver, kidney, neurologic, hematologic, metabolic, or significant cardiovascular disease (except isolated hypertension)
Show all 14Show fewer
- History of chronic sinusitis or significant nasal allergies requiring frequent or daily treatment
- Acute moderate or severe illness at time of enrollment, with or without fever
- Receipt of influenza vaccine during the current season or within the past 2 weeks
- Receipt of another live vaccine within 4 weeks prior to enrollment or planned during study period
- Use of influenza antiviral medications (e.g., oseltamivir, zanamivir) within 48 hours prior to vaccination or planned use within 14 days after vaccination
- History of severe allergic reaction to influenza vaccine or any component of FluMist (including egg allergy if applicable)
- History of Guillain-Barré syndrome following influenza vaccination
- Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Shanna H Graves, AAS, 205-975-2845, shannagraves@uabmc.edu
About this study
Official title: Characterizing Local Mucosal Responses to Live Attenuated Influenza Vaccine in Healthy Adults
This study is looking at how the immune system in the nose responds after receiving the FluMist nasal flu vaccine in healthy adults. FluMist is an FDA-approved influenza vaccine that is given as a nasal spray.
Healthy volunteers aged 18 to 65 who do not have chronic medical conditions, do not smoke, and have not recently received a flu vaccine will be enrolled. Participants will have three study visits over approximately one week. At the first visit, participants will be screened, give informed consent, and receive the FluMist vaccine. Nasal swabs and a gentle saline nasal wash will be collected before vaccination and again at two and four days after vaccination.
Read more
The samples collected will be used to study changes in immune cells, proteins, and viral activity in the nose using laboratory techniques such as gene expression and protein analysis. This information may help researchers better understand how flu vaccines work at the site where infection begins and may support the development of improved vaccines in the future.
There is no direct medical benefit expected for participants. Participation is voluntary, and all study procedures will be performed by trained clinical staff.
Read the detailed description
This is a prospective interventional study evaluating mucosal immune and epithelial responses in healthy adults following administration of the FDA-approved live attenuated influenza vaccine (FluMist) given as an intranasal spray. Healthy volunteers aged 18 to 65 years who do not smoke and who meet eligibility criteria will be enrolled.
Participants will complete three study visits over approximately one week. At the first visit, informed consent, screening, baseline nasal swabs and nasal wash will be performed, followed by administration of FluMist. Follow-up nasal samples and safety assessments will be collected at approximately 2 and 4 days after vaccination.
Nasal samples will be analyzed using single-cell RNA sequencing, proteomics, and RT-qPCR to assess local immune, epithelial, and viral responses. Samples will be coded, stored under secure conditions, and retained for up to five years after study completion.
The objective of the study is to characterize early mucosal immune responses to FluMist vaccination and improve understanding of influenza vaccine-induced immunity at the site of infection.
- Being tested
- FluMist (Live Attenuated Influenza Vaccine)
- Keywords
- FluMist, LAIV, influenza vaccine, mucosal immunity, nasal immune response, intranasal vaccine, healthy volunteers, nasal swab, proteomics
- 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 (Live Attenuated Influenza Vaccine)Biological
FluMist is an FDA-approved live attenuated influenza vaccine administered as a nasal spray. Participants will receive a single standard dose of FluMist intranasally, with half the dose administered into each nostril by trained study personnel according to manufacturer instructions. The vaccine is used in this study to evaluate local mucosal and immune responses in the nasal cavity.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults Receiving Intranasal FluMist Vaccination | Experimental | Participants in this single-arm study will receive the FDA-approved live attenuated influenza vaccine (FluMist) administered intranasally according to standard dosing guidelines. All participants will undergo nasal sampling procedures, including nasal swabs and nasal wash, at baseline prior to vaccination and at approximately 2 and 4 days following vaccination. Samples will be collected to evaluate temporal changes in mucosal immune and epithelial responses using molecular and proteomic analyses. No placebo or comparator intervention is used. Receives: Biological: FluMist (Live Attenuated Influenza Vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nasal Mucosal Immune Response Following FluMist Vaccination
This outcome measure evaluates changes in the nasal mucosal immune and epithelial response following administration of the intranasal live attenuated influenza vaccine (FluMist). Nasal swab and nasal wash samples will be collected at baseline (pre-vaccination) and at approximately 2 and 4 days post-vaccination. Samples will be analyzed using single-cell RNA sequencing, proteomics, and RT-qPCR to assess changes in immune cell populations, gene expression profiles, protein expression, and viral activity over time.
Measured: Baseline through 4 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal Immune Response to Influenza VaccinationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, prospective interventional study in which all participants receive the same intervention (intranasal FluMist vaccination). Participants are followed longitudinally with repeated nasal sampling at baseline and at defined time points after vaccination (Day 2 and Day 4) to assess temporal changes in mucosal immune and epithelial responses. No control group or randomization is used.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Harrod, University of Alabama at Birmingham
- Investigators
- Kevin S Harrod, PhD, Principal investigator, UAB All Study (Central)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726862
- Sponsor's protocol ID
- IRB-300016968
- Other IDs
- UAB
- Acronym
- MOSAIC
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. The study involves collection of sensitive health information and high-dimensional molecular data (including transcriptomic and proteomic analyses) linked to coded identifiers. To protect participant privacy and confidentiality, data will be stored in secure, HIPAA-compliant systems with access limited to IRB-approved study personnel. Only de-identified, aggregated results will be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Local Mucosal Responses to Live Attenuated Influenza Vaccine in Healthy Adults
- ClinicalTrials.gov ID
- NCT07726862
- Acronym / sponsor ID
- MOSAIC / IRB-300016968
- Keywords
- FluMist, LAIV, influenza vaccine, mucosal immunity, nasal immune response, intranasal vaccine, healthy volunteers, nasal swab, proteomics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 24 Jul 2026 (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.
This study is looking at how the immune system in the nose responds after receiving the FluMist nasal flu vaccine in healthy adults. FluMist is an FDA-approved influenza vaccine that is given as a nasal spray.
Healthy volunteers aged 18 to 65 who do not have chronic medical conditions, do not smoke, and have not recently received a flu vaccine will be enrolled. Participants will have three study visits over approximately one week. At the first visit, participants will be screened, give informed consent, and receive the FluMist vaccine. Nasal swabs and a gentle saline nasal wash will be collected before vaccination and again at two and four days after vaccination.
The samples collected will be used to study changes in immune cells, proteins, and viral activity in the nose using laboratory techniques such as gene expression and protein analysis. This information may help researchers better understand how flu vaccines work at the site where infection begins and may support the development of improved vaccines in the future.
There is no direct medical benefit expected for participants. Participation is voluntary, and all study procedures will be performed by trained clinical staff.
Detailed description
This is a prospective interventional study evaluating mucosal immune and epithelial responses in healthy adults following administration of the FDA-approved live attenuated influenza vaccine (FluMist) given as an intranasal spray. Healthy volunteers aged 18 to 65 years who do not smoke and who meet eligibility criteria will be enrolled.
Participants will complete three study visits over approximately one week. At the first visit, informed consent, screening, baseline nasal swabs and nasal wash will be performed, followed by administration of FluMist. Follow-up nasal samples and safety assessments will be collected at approximately 2 and 4 days after vaccination.
Nasal samples will be analyzed using single-cell RNA sequencing, proteomics, and RT-qPCR to assess local immune, epithelial, and viral responses. Samples will be coded, stored under secure conditions, and retained for up to five years after study completion.
The objective of the study is to characterize early mucosal immune responses to FluMist vaccination and improve understanding of influenza vaccine-induced immunity at the site of infection.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, prospective interventional study in which all participants receive the same intervention (intranasal FluMist vaccination). Participants are followed longitudinally with repeated nasal sampling at baseline and at defined time points after vaccination (Day 2 and Day 4) to assess temporal changes in mucosal immune and epithelial responses. No control group or randomization is used.
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults Receiving Intranasal FluMist Vaccination | Experimental | Biological: FluMist (Live Attenuated Influenza Vaccine)Participants in this single-arm study will receive the FDA-approved live attenuated influenza vaccine (FluMist) administered intranasally according to standard dosing guidelines. All participants will undergo nasal sampling procedures, including nasal swabs and nasal wash, at baseline prior to vaccination and at approximately 2 and 4 days following vaccination. Samples will be collected to evaluate temporal changes in mucosal immune and epithelial responses using molecular and proteomic analyses. No placebo or comparator intervention is used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy adults aged 18 to 65 years
- Non-smokers (no smoking or vaping within the past 6 months)
- No chronic lung disease or significant chronic medical conditions
- No current or recent (within 1 month) upper or lower respiratory infection
- Able and willing to provide informed consent
Key exclusion criteria (14 listed)
- Age under 18 or over 65 years
- Pregnancy or breastfeeding
- Prisoners
- Non-English speaking individuals
- Immunocompromised individuals (including HIV/AIDS, immunosuppressive therapy, chemotherapy, or primary immunodeficiency)
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 (Live Attenuated Influenza Vaccine)FluMist is an FDA-approved live attenuated influenza vaccine administered as a nasal spray. Participants will receive a single standard dose of FluMist intranasally, with half the dose administered into each nostril by trained study personnel according to manufacturer instructions. The vaccine is used in this study to evaluate local mucosal and immune responses in the nasal cavity. | Biological | Healthy Adults Receiving Intranasal FluMist Vaccination |
Primary outcome
Change in Nasal Mucosal Immune Response Following FluMist Vaccination
Time frame: Baseline through 4 days post-vaccination
This outcome measure evaluates changes in the nasal mucosal immune and epithelial response following administration of the intranasal live attenuated influenza vaccine (FluMist). Nasal swab and nasal wash samples will be collected at baseline (pre-vaccination) and at approximately 2 and 4 days post-vaccination. Samples will be analyzed using single-cell RNA sequencing, proteomics, and RT-qPCR to assess changes in immune cell populations, gene expression profiles, protein expression, and viral activity over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. The study involves collection of sensitive health information and high-dimensional molecular data (including transcriptomic and proteomic analyses) linked to coded identifiers. To protect participant privacy and confidentiality, data will be stored in secure, HIPAA-compliant systems with access limited to IRB-approved study personnel. Only de-identified, aggregated results will be reported in publications and presentations.
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.
Kevin S Harrod, PhD principal investigator
UAB All Study (Central)
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 (Live Attenuated Influenza Vaccine) in people with Mucosal Immune Response to Influenza Vaccination, 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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 13 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanna H Graves, AAS (205-975-2845, shannagraves@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nasal Mucosal Immune Response Following FluMist Vaccination (time frame: Baseline through 4 days post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.