Strategies for Enhancing Mucosal Immunity to Influenza Vaccine (NCT01385215) | Clinical Trial Compass
CompletedEarly Phase 1
Strategies for Enhancing Mucosal Immunity to Influenza Vaccine
United States60 participantsStarted 2011-04
Plain-language summary
The purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). The investigators will measure the systemic (through out the body) and mucosal immune responses (how your body recognizes and defends itself against bacteria) to nasally administered influenza vaccine, and determine if nasal immunization results in immunity (your body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral and reproductive), in comparison with intramuscular administration and placebo (inactive substance given in the same form as the active drug).
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy men and women ages 18-50 years
* Non-smokers (defined as no tobacco use within the last 12 months and less than 10 pack-year lifetime tobacco use)
* Willing and able to provide written informed consent
* Able to speak and understand English
* Women of childbearing potential must have a negative serum pregnancy test.
Exclusion Criteria:
* Influenza vaccination within 6 months prior to screening date
* Symptoms of respiratory infection during the 14 days prior to screening
* Temperature \>38.3o C during the period spanning 72 hours prior to screening and the time of immunization.
* History of allergy to egg, influenza vaccine or vaccine ingredients
* History of Guillain-Barre syndrome
* History of Bell's palsy
* Tonsillectomy, adenoidectomy or prior surgery to the paranasal sinus cavity.
* Physician diagnosis of or personal history of allergic or chronic rhinitis
* Physician diagnosis of or personal history of asthma
* Acute sinusitis within 30 days prior to screening
* Use of antibiotics within 14 days prior to screening
* Requirement for use of nasal corticosteroids for the period beginning 30 days prior to screening through final study visit
* Requirement for use of antihistamines (systemic, intranasal or intraocular) for the period beginning 72 hours prior to screening through final study visit
* Use of immunomodulating drugs or systemic corticosteroids within 6 months prior to screening (includes but is not limited to azathioprine, methotre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in hemagglutinin antibody titers from baseline to Day 28 in serum and mucosal secretions.