Strategies for Enhancing Mucosal Immunity to Influenza Vaccine

NCT01385215 | Completed Early Phase 1

• 1 other identifier: Pro00024277
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Mucosal Immunity

Keywords

Vaccination; Mucosal Immunity; Nasal Immunization

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Number of subjects with adverse events.

  Baseline to Day 28

• Comparison of hemagglutinin antibody titers between intranasal and intramuscular route of administration, from baseline to Day 28.

  Baseline to Day 28

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Fluzone

Nasal Aerosol Immunization

PLACEBO COMPARATOR

Drug: Fluzone

Nasal Droplet Immunization

PLACEBO COMPARATOR

Drug: Fluzone

Intramuscular Immunization

PLACEBO COMPARATOR

Drug: Fluzone

Interventions

Fluzone DRUG

0.5 ml/15 micrograms

Intramuscular Immunization

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• John Sundy: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• John Sundy, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: June 30, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 6, 2012

Record last verified: 2012-12

Locations

US (1)