Self-Administered Nasal Influenza Feasibility Study

NCT01933048 | Completed Phase 4 Results DMC

• 1 other identifier: IDCRP-070
• Study Type: interventional
• Target: 1,077
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group self-administration of LAIV.

Conditions

Influenza

Keywords

influenza

Outcome Measures

Primary Outcomes (1)

• Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects

  28+/- 7 days post-vaccination

Secondary Outcomes (2)

• Difference and Proportion in Seroresponse of Subjects

  28+/- 7 days post-vaccination

• Difference and Proportion in Seroconversion of Subjects

  28+/- 7 days post-vaccination

Other Outcomes (2)

• Feasibility of Self-administration Prior to Vaccine Administration

  28+/- 7 days post-vaccination

• Feasibility of Self-administration Following Vaccine Administration

  28+/- 7 days post-vaccination

Study Arms (2)

Healthcare Worker Administration

OTHER

FluMist administered by a Healthcare Worker

Drug: FluMist

Self-Administration

EXPERIMENTAL

FluMist self-administered by subject

Drug: FluMist

Interventions

FluMist DRUG

FluMist Intranasal Vaccine

Also known as: influenza virus vaccine LAIV4

Healthcare Worker Administration; Self-Administration

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or healthy, non-pregnant females
• years of age
• Department of Defense beneficiary including active duty members
• Able to speak and understand English, and provide written informed consent

You may not qualify if:

• Known hypersensitivity to eggs, egg-proteins, gentamicin, gelatin, or arginine or life-threatening reactions to previous influenza vaccination
• Prior receipt of the 2012-2013 seasonal influenza vaccine for 2012-2013 season or prior receipt of the 2013-2014 seasonal influenza vaccine for 2013-2014 season
• Known clinical diagnosis of reactive airway disease, wheezing, or asthma (excluding exercise-induced asthma)
• Reported febrile upper respiratory illness (oral or tympanic temperature greater than 100°F or a subjective fever) at the time of or within the 24 hours prior to immunization
• Known to be pregnant, possibly pregnant or breast-feeding
• Known diagnosis of human immunodeficiency virus (HIV) infection, chronic active hepatitis B infection, or chronic hepatitis C infection
• History of Guillain-Barre Syndrome
• Household member known to be immunocompromised (either a known disease or disorder such as HIV, or other acquired or congenital immunodeficiency disorder, or taking systemic steroids (any dose) or high daily dose inhaled steroids, tumor necrosis factor-alpha inhibitors, or monoclonal antibodies used to treat autoimmune disease)
• Receipt of medications with activity against influenza A and/or B (ex: Tamiflu®, Relenza®, amantadine, or rimantadine) within 48 hours prior to vaccine administration
• Use of any oral or intravenous systemic steroids (any dose) or any daily dose inhaled steroids
• At the time of enrollment, any person who is trained to administer intranasal vaccines or who has been involved in any recurring role associated with the administration of intranasal vaccines to others in the clinic or military treatment facility (MTF)
• Prior participation in this research study
• Any acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, interfere with the evaluation of responses, or render the subject unable to meet the requirements of the protocol. These conditions may include, but are not limited to: history of significant renal impairment (dialysis and treatment for kidney disease, including diabetic and hypertensive kidney disease); poorly controlled diabetes mellitus or patients with diabetes mellitus on insulin (subjects with well-controlled diabetes mellitus on oral agents may enroll as long there has been no dosage increase within the past 6 months); cardiac insufficiency, if heart failure is present; an arteriosclerotic event during the 6 months prior to enrollment (e.g., history of myocardial infarction, stroke, recanalization of femoral arteries, or transient ischemic attack).
• If the individual received a live virus vaccine (e.g., Varicella, Measles-Mumps-Rubella, Yellow Fever, Smallpox) in the past 4 weeks, they should wait 28 days before receiving LAIV. There is no reason to defer vaccination if the individual was vaccinated with an inactivated vaccine or if they have recently received blood or other antibody-containing blood products.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead

Study Sites (2)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

San Antonio Military Health System

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

• Burgess TH, Murray CK, Bavaro MF, Landrum ML, O'Bryan TA, Rosas JG, Cammarata SM, Martin NJ, Ewing D, Raviprakash K, Mor D, Zell ER, Wilkins KJ, Millar EV. Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance. Vaccine. 2015 Jul 31;33(32):3894-9. doi: 10.1016/j.vaccine.2015.06.061. Epub 2015 Jun 25.

  PMID: 26117150 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

Subjects were not followed for clinical outcomes during the influenza season.

Results Point of Contact

• Title: Eugene V. Millar, PhD
• Organization: Uniformed Services University of the Health Sciences

emillar@idcrp.org

301-816-8451

Study Officials

• Timothy Burgess, MD, MPH

  Uniformed Services University of the Health Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 30, 2013
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 15, 2023
• Results First Posted: September 12, 2017

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)