Clinical trial NCT01385215: Strategies for Enhancing Mucosal Immunity to Influenza Vaccine
Official title: Strategies for Enhancing Mucosal Immunity to Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Mucosal Immunity
Keywords: Vaccination
Mucosal Immunity
Nasal Immunization
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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).


Eligibility criteria: 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, methotrexate, mycophenolate mofetil, tumor necrosis factor inhibitors, cyclosporine, tacrolimus)
* Past or present history of allergen immunotherapy to within the last 10 years.
* Students or employees who are under direct supervision by any of the investigators in this protocol are not eligible to participate.
* Subjects who abuse alcohol or illicit substances will be excluded.
* Other medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements.
* Nursing mothers.
* Other investigational medication use within 30 days of screening.

Primary outcomes:
measure: Change in hemagglutinin antibody titers from baseline to Day 28 in serum and mucosal secretions.
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Number of subjects with adverse events.
timeFrame: Baseline to Day 28
measure: Comparison of hemagglutinin antibody titers between intranasal and intramuscular route of administration, from baseline to Day 28.
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: John Sundy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: