Intranasal Vaccine for Mucosal Immunity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the immune system responds to an intranasal flu vaccine, with a focus on tissues near the nose, such as the adenoids and tonsils. By studying these tissues, researchers hope to learn how this type of vaccine affects the immune system differently from the usual shots. Participants will either receive the live attenuated influenza vaccine or not, and researchers will examine tissues from their adenoid or tonsil surgeries. The trial seeks individuals undergoing tonsil and adenoid surgery to treat sleep apnea who have not yet received their flu shot this year. As a Phase 4 trial, this research focuses on an already FDA-approved and effective vaccine, aiming to understand its benefits for more patients.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for this treatment?
Studies have shown that the live attenuated influenza vaccine (LAIV), administered as a nasal spray, is safe and well-tolerated. This vaccine uses weakened viruses, preventing it from causing the flu. Research indicates that the likelihood of the vaccine virus spreading to others at home is very low, ranging from 0.58% to 2.87%. It has proven safe and effective for both adults and children, including those aged 18 months to 18 years, even with asthma. Overall, LAIV is considered a safe method for flu protection.12345
Why are researchers enthusiastic about this study treatment?
Researchers are excited about the intranasal flu vaccine because it offers a unique delivery method through the nose, which can stimulate a stronger immune response directly at the mucosal surfaces where viruses often enter the body. Unlike traditional flu shots that are injected into the muscle, this vaccine could potentially provide better protection at the initial site of infection. Additionally, the ease of administration without needles could increase vaccination rates among those who are needle-averse, making it a promising alternative to existing flu vaccines.
What is the effectiveness track record for the live attenuated influenza vaccine?
Research has shown that the Live Attenuated Influenza Vaccine (LAIV), a nasal spray, effectively prevents the flu. It mimics a natural infection, offering broader protection, especially for children. During the 2022–2023 flu season, LAIV demonstrated 38% effectiveness, comparable to flu shots. Some studies found that FluMist, a common LAIV, can protect against several flu strains with up to 80% effectiveness for certain types. In this trial, participants in the "Interventional LAIV" arm will receive the intranasal flu vaccine, while others will be in the "No Intervention" arm. Overall, the nasal spray vaccine is a practical choice and more effective than not getting vaccinated at all.678910
Are You a Good Fit for This Trial?
This trial is for patients scheduled for adenoidectomy and/or tonsillectomy due to obstructive sleep apnea. They will receive an FDA-approved live attenuated influenza vaccine intranasally before surgery. The study requires participants who have not received other vaccines recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Administration of the FDA approved live attenuated influenza vaccine or no vaccine to patients undergoing adenoidectomy and/or tonsillectomy
Follow-up
Participants are monitored for serological outcomes and immune response from enrollment to 4 weeks after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Live Attenuated Influenza Vaccine
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor