Impact of VaccinationPhase 4NCT07093281
Intranasal LAIV Mucosal Immunity Examination
A Phase 4 study testing Live Attenuated Influenza Vaccine in people with Impact of Vaccination, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The research of the investigators is focused on the understanding how the immune system functions and responds to intranasal vaccines. Intranasal vaccines do not lead to the same changes in the blood that intramuscular vaccines do. Read more about this study
- Who is it for?
- Ages 2 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Impact of Vaccination
- What is being tested?
- Live Attenuated Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Jul 2029
- 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 2 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient undergoing tonsillectomy and adenoidectomy as part of the standard of care for sleep apnea
Who cannot join
- Chronic Tonsillitis
- Immune Deficiency
- Already received this year's flu vaccine
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 Maryland Medical Center
Baltimore, Maryland, 21231
Adam Kaufman, MD PhD, 667-214-2382, adam.kaufman@som.umaryland.edu
About this study
Official title: The Impact of Live Attenuated Intranasal Influenza Vaccine Exposure on Mucosal Immunity
The research of the investigators is focused on the understanding how the immune system functions and responds to intranasal vaccines. Intranasal vaccines do not lead to the same changes in the blood that intramuscular vaccines do. Therefore, the investigators want to look at the function of immune (lymphoid) organs that are near the nose. The closest immune organs are the adenoids and tonsils. Mice do not have tonsils allowing for the investigators to answer these questions. Human lymphoid tissue will allow the investigators to better understand the molecular behavior of these cells in humans.
The purpose of this protocol is to administer the FDA approved live attenuated influenza vaccine or no vaccine to patients undergoing adenoidectomy and/or tonsillectomy for obstructive sleep apnea prior to surgery and then collect the tissue (adenoid and/or tonsil tissue) that would normally be discarded from surgery. This will allow for improved understanding of what happens after vaccination.
- Conditions
- Impact of Vaccination
- Being tested
- Live Attenuated Influenza Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Influenza VaccineBiological
Nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Interventional LAIV | Experimental | Intranasal Flu Vaccine Receives: Biological: Live Attenuated Influenza Vaccine |
| No Intervention | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological outcomes will be compared before and after vaccination and between groups.
The comparisons will specifically compare:
Mean HAI Ab titers in serum and mucosal secretions
Measured: From enrollment to 4 weeks after surgery is completed
Secondary outcomes (4)
Hemagglutinin Levels
Mean HA IgG and IgA titers in serum and mucosal secretions
Measured: From enrollment to 4 weeks after surgery
Neuraminidase Levels
Mean NA IgG and IgA titers in serum and in mucosal secretions
Measured: From enrollment to 4 weeks after surgery
Influenza Specific Antibodies
Non-neutralizing influenza-specific antibody titers before and after vaccination
Measured: From enrollment to 4 weeks after surgery
Seroconversion rats
Comparison of serconversion rates
Measured: From enrollment to 4 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startFeb 2027 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impact of VaccinationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Kaufman, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093281
- Sponsor's protocol ID
- HP-00114022
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Live Attenuated Intranasal Influenza Vaccine Exposure on Mucosal Immunity
- ClinicalTrials.gov ID
- NCT07093281
- Acronym / sponsor ID
- HP-00114022
- Conditions
- Impact of Vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 30 Jul 2025 (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 research of the investigators is focused on the understanding how the immune system functions and responds to intranasal vaccines. Intranasal vaccines do not lead to the same changes in the blood that intramuscular vaccines do. Therefore, the investigators want to look at the function of immune (lymphoid) organs that are near the nose. The closest immune organs are the adenoids and tonsils. Mice do not have tonsils allowing for the investigators to answer these questions. Human lymphoid tissue will allow the investigators to better understand the molecular behavior of these cells in humans.
The purpose of this protocol is to administer the FDA approved live attenuated influenza vaccine or no vaccine to patients undergoing adenoidectomy and/or tonsillectomy for obstructive sleep apnea prior to surgery and then collect the tissue (adenoid and/or tonsil tissue) that would normally be discarded from surgery. This will allow for improved understanding of what happens after vaccination.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional LAIV | Experimental | Biological: Live Attenuated Influenza VaccineIntranasal Flu Vaccine |
| No Intervention | No intervention | –No Intervention |
Who may qualify
- Ages
- 2 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing tonsillectomy and adenoidectomy as part of the standard of care for sleep apnea
Key exclusion criteria (3 listed)
- Chronic Tonsillitis
- Immune Deficiency
- Already received this year's flu vaccine
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 |
|---|---|---|
| Live Attenuated Influenza VaccineNasal spray | Biological | Interventional LAIV |
Primary outcome
Serological outcomes will be compared before and after vaccination and between groups.
Time frame: From enrollment to 4 weeks after surgery is completed
The comparisons will specifically compare: Mean HAI Ab titers in serum and mucosal secretions
4 secondary outcomes
Hemagglutinin Levels
Time frame: From enrollment to 4 weeks after surgery
Neuraminidase Levels
Time frame: From enrollment to 4 weeks after surgery
Influenza Specific Antibodies
Time frame: From enrollment to 4 weeks after surgery
Seroconversion rats
Time frame: From enrollment to 4 weeks post surgery
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 3 Sep 2026.
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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.
University of Maryland Medical Center
Baltimore, United States
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 Live Attenuated Influenza Vaccine in people with Impact of Vaccination, run by University of Maryland, Baltimore 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 1 inclusion and 3 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 3 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serological outcomes will be compared before and after vaccination and between groups. (time frame: From enrollment to 4 weeks after surgery is completed). 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 3 Sep 2026.