Strategies for Enhancing Mucosal Immunity to Influenza Vaccine

Mucosal Immunity Clinical Trial

Official title:

Strategies for Enhancing Mucosal Immunity to Influenza Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385215
• Other study ID #: Pro00024277
• Status: Completed
• Phase: Phase 0
• First received: April 25, 2011
• Last updated: December 5, 2012
• Start date: April 2011
• Est. completion date: June 2011

Study information

• Verified date: December 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Mucosal Immunity

Intervention

Drug:
• Fluzone
0.5 ml/15 micrograms
• Fluzone
0.5 ml/60 micrograms

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
John Sundy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemagglutinin antibody titers from baseline to Day 28 in serum and mucosal secretions.	Assessments will include hemagglutination inhibition and antibody isotypes determination.	Baseline to Day 28	No
Secondary	Number of subjects with adverse events.		Baseline to Day 28	Yes
Secondary	Comparison of hemagglutinin antibody titers between intranasal and intramuscular route of administration, from baseline to Day 28.		Baseline to Day 28	No