Self-Administered Nasal Influenza Feasibility Study (SNIF)

• ClinicalTrials.gov Identifier: NCT01933048
• Recruitment Status: Completed
• First Posted: August 30, 2013
• Results First Posted: September 12, 2017
• Last Update Posted: September 12, 2017
• Sponsor: Uniformed Services University of the Health Sciences
• Information provided by (Responsible Party): Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza	Drug: FluMist	Phase 4

Detailed Description:

This Phase IV, open-label, prospective clinical trial assesses SA-LAIV, testing whether the immunogenicity of SA-LAIV is non-inferior to that of HCWA-LAIV, as well as evaluating the feasibility of utilizing group administration for SA-LAIV. Subjects will be enrolled into one of two major treatment arms: HCWA-LAIV (Estimated N = 550) and SA-LAIV (Estimated N = 550). Enrollment into each major treatment arm will be stratified by study site. Enrollment in the HCWA-LAIV and SA-LAIV treatment arms may occur concurrently at each site. Subjects enrolling in the study will be randomized to HCWA or SA, and within the SA arm to either individual self-administration, or group administration. Specifically, following self-administration of LAIV to 190 individual subjects, 180 subjects will be vaccinated in 36 groups of 5 and 180 subjects will be vaccinated in 18 groups of 10. All vaccinations in the SA-LAIV arm will be given under the direction and supervision of a research staff member who is trained to administer LAIV vaccines. Following immunization all subjects will return for one visit at approximately 28 (± 7) days for follow-up.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1077 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Self-Administered Nasal Influenza Vaccine: Immunogenicity and Feasibility of Group Administration
• Study Start Date: September 2012
• Actual Primary Completion Date: October 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

Arm	Intervention/treatment
Healthcare Worker Administration; FluMist administered by a Healthcare Worker	Drug: FluMist; FluMist Intranasal Vaccine; Other Name: influenza virus vaccine LAIV4
Experimental: Self-Administration; FluMist self-administered by subject	Drug: FluMist; FluMist Intranasal Vaccine; Other Name: influenza virus vaccine LAIV4

Outcome Measures

Primary Outcome Measures :

1. Post-vaccination Geometric Mean Titer (GMT) Ratios Between HCWA and SA Subjects [ Time Frame: 28+/- 7 days post-vaccination ]

Secondary Outcome Measures :

1. Difference and Proportion in Seroresponse of Subjects [ Time Frame: 28+/- 7 days post-vaccination ]
2. Difference and Proportion in Seroconversion of Subjects [ Time Frame: 28+/- 7 days post-vaccination ]

Other Outcome Measures:

1. Feasibility of Self-administration Prior to Vaccine Administration [ Time Frame: 28+/- 7 days post-vaccination ]
2. Feasibility of Self-administration Following Vaccine Administration [ Time Frame: 28+/- 7 days post-vaccination ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 49 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Healthy males or healthy, non-pregnant females
• 18-49 years of age
• Department of Defense beneficiary including active duty members
• Able to speak and understand English, and provide written informed consent

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, California

Naval Medical Center San Diego

San Diego, California, United States, 92134

United States, Texas

San Antonio Military Health System

Fort Sam Houston, Texas, United States, 78234

Sponsors and Collaborators

Uniformed Services University of the Health Sciences

Investigators

• Study Director: Timothy Burgess, MD, MPH; Uniformed Services University of the Health Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Timothy Burgess, MD, MPH, Captain, Medical Corps, US Navy, Uniformed Services University of the Health Sciences
• ClinicalTrials.gov Identifier: NCT01933048
• Other Study ID Numbers: IDCRP-070
• First Posted: August 30, 2013
• Results First Posted: September 12, 2017
• Last Update Posted: September 12, 2017
• Last Verified: August 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Sharing of individual participant data (IPD) would require revisions and additional regulatory approval, that will not be pursued.

Keywords provided by Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences:

influenza

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs