Strategies for Enhancing Mucosal Immunity to Influenza Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Sundy, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01385215
First received: April 25, 2011
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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).


Condition Intervention Phase
Mucosal Immunity
Drug: Fluzone
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Strategies for Enhancing Mucosal Immunity to Influenza Vaccine

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Change in hemagglutinin antibody titers from baseline to Day 28 in serum and mucosal secretions. [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]
    Assessments will include hemagglutination inhibition and antibody isotypes determination.


Secondary Outcome Measures:
  • Number of subjects with adverse events. [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: Yes ]
  • Comparison of hemagglutinin antibody titers between intranasal and intramuscular route of administration, from baseline to Day 28. [ Time Frame: Baseline to Day 28 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Fluzone
0.5 ml/60 micrograms
Placebo Comparator: Nasal Aerosol Immunization Drug: Fluzone
0.5 ml/60 micrograms
Placebo Comparator: Nasal Droplet Immunization Drug: Fluzone
0.5 ml/60 micrograms
Placebo Comparator: Intramuscular Immunization Drug: Fluzone
0.5 ml/15 micrograms

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385215

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
John Sundy
Investigators
Principal Investigator: John Sundy, MD, PhD Duke University
  More Information

No publications provided

Responsible Party: John Sundy, Associate Professor of Medicine, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01385215     History of Changes
Other Study ID Numbers: Pro00024277
Study First Received: April 25, 2011
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
Vaccination
Mucosal Immunity
Nasal Immunization

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014