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Evaluation of Free Air Portable Air Powered Respirator

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Free Air Portable Air Powered Respirator
N95 Respirator
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Live Attenuated Influenza Vaccine (FluMist), Free Air Portable Air Powered Respirator, N95 Respirator, Personal Protective Equipment, Viral Transmission

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-49 years of age
  • Employee or student at Wake Forest University School of Medicine and Wake Forest University

Exclusion Criteria:

  • Respiratory tract disorders and other chronic diseases, and medical conditions and treatments which are contraindications to mask usage
  • Severe claustrophobia or inability to tolerate masks
  • Contraindications to FluMist:
  • Children younger than 18 years; proposed age range is 18-49
  • Adults 50 years and older; proposed age range is 18-49
  • People who have received the live attenuated influenza vaccine within 3 weeks of the exposure sessions
  • People with a history of severe allergic reaction to any component of the vaccine or to a previous dose of any influenza vaccine
  • People who are allergic to eggs
  • Pregnant women
  • People with weakened immune systems (immunosuppression)
  • People who have taken influenza antiviral drugs within the previous 48 hours
  • People who care for severely immunocompromised persons who require a protective environment (or otherwise avoid contact with those persons for 7 days after getting the nasal spray vaccine)
  • People of any age with asthma might be at increased risk for wheezing after getting the nasal spray vaccine
  • The safety of the nasal spray vaccine has not been established in people with underlying medical conditions that place them at high risk of serious flu complications. This includes children and adults who have lung disease, heart disease (except isolated hypertension), kidney disease (like diabetes), kidney or liver disorders, neurologic/neuromuscular, or metabolic disorders. Moderate or severe acute illness with or without fever is a general precaution for vaccination
  • Guillain-Barre Syndrome (GBS) within 6 weeks following a previous dose of influenza vaccine is considered a precaution for use of all influenza vaccines
  • Treatment with nasal decongestants, nasal antibiotic and/or steroid preparations will not be allowed

Sites / Locations

  • Wake Forest School Of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

N95 Respirator

Free Air Portable Air Powered Respirator

Arm Description

Participants in this arm will wear an N95 respirator and safety goggles during Live Attenuated Influenza Vaccine exposure.

Participants in this arm will wear a Free Air PAPR and safety goggles during Live Attenuated Influenza Vaccine exposure.

Outcomes

Primary Outcome Measures

Nasal Swabs
A nasal swab will be performed immediately following the exposure.
Nasopharyngeal swabs
A nasopharyngeal swab will be performed immediately following the exposure.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2015
Last Updated
March 3, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
Free Air
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1. Study Identification

Unique Protocol Identification Number
NCT02487147
Brief Title
Evaluation of Free Air Portable Air Powered Respirator
Official Title
Evaluation of Free Air Portable Air Powered Respirator System for Prevention of Influenza Transmission
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 14, 2016 (Actual)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
December 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Free Air

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the efficacy of the Free Air Portable Air Powered Respirator (PAPR) system versus a N95 mask in preventing nasal detection of influenza following an exposure. The investigators hypothesize the use of the Free Air PAPR system will be superior to a N95 respirator at interrupting the exposure of the study participants to aerosolized influenza virus particles.
Detailed Description
Airborne transmission represents one of the most rapidly spreading and least understood dissemination mechanisms for pathogens. Public health strategies to prevent and control the often explosive outbreaks associated with such pathogens are: 1) vaccination and treatment, if available, 2) decontamination of the exposed areas and surfaces, and 3) isolation and barrier precautions such as face masks. Unfortunately, evidence of the efficacy of currently recommended barrier precautions is currently lacking. Attempts to validate the effectiveness of personal protective equipment are limited to in vitro experiments with mannequin heads. This human exposure study will provide a much more accurate life-like exposure scenario. The use of live attenuated influenza virus vaccine has been proven to be safe. Objectives: Evaluate the Free Air Portable Air Powered Respirator (PAPR) versus an N95 face mask for preventing the airborne cross-transmission of aerosolized influenza in human participants. Methods: Participants will be randomized to one of two arms: a) N95 respirator, or b) Free Air PAPR System. The primary outcome will be the rate of the transmission for the 2 study groups, so a nasal and nasopharyngeal swab will be performed immediately following the exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Live Attenuated Influenza Vaccine (FluMist), Free Air Portable Air Powered Respirator, N95 Respirator, Personal Protective Equipment, Viral Transmission

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N95 Respirator
Arm Type
Active Comparator
Arm Description
Participants in this arm will wear an N95 respirator and safety goggles during Live Attenuated Influenza Vaccine exposure.
Arm Title
Free Air Portable Air Powered Respirator
Arm Type
Experimental
Arm Description
Participants in this arm will wear a Free Air PAPR and safety goggles during Live Attenuated Influenza Vaccine exposure.
Intervention Type
Other
Intervention Name(s)
Free Air Portable Air Powered Respirator
Other Intervention Name(s)
Free Air PAPR
Intervention Description
The Free Air PAPR is a portable air powered respirator that you will wear like a backpack with a mask and tubing attached.
Intervention Type
Other
Intervention Name(s)
N95 Respirator
Intervention Description
The N95 respirator is a mask that is standardly used clinically at Wake Forest Baptist Health.
Primary Outcome Measure Information:
Title
Nasal Swabs
Description
A nasal swab will be performed immediately following the exposure.
Time Frame
Immediately following Live Attenuated Influenza Vaccine exposure
Title
Nasopharyngeal swabs
Description
A nasopharyngeal swab will be performed immediately following the exposure.
Time Frame
Immediately following Live Attenuated Influenza Vaccine exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-49 years of age Employee or student at Wake Forest University School of Medicine and Wake Forest University Exclusion Criteria: Respiratory tract disorders and other chronic diseases, and medical conditions and treatments which are contraindications to mask usage Severe claustrophobia or inability to tolerate masks Contraindications to FluMist: Children younger than 18 years; proposed age range is 18-49 Adults 50 years and older; proposed age range is 18-49 People who have received the live attenuated influenza vaccine within 3 weeks of the exposure sessions People with a history of severe allergic reaction to any component of the vaccine or to a previous dose of any influenza vaccine People who are allergic to eggs Pregnant women People with weakened immune systems (immunosuppression) People who have taken influenza antiviral drugs within the previous 48 hours People who care for severely immunocompromised persons who require a protective environment (or otherwise avoid contact with those persons for 7 days after getting the nasal spray vaccine) People of any age with asthma might be at increased risk for wheezing after getting the nasal spray vaccine The safety of the nasal spray vaccine has not been established in people with underlying medical conditions that place them at high risk of serious flu complications. This includes children and adults who have lung disease, heart disease (except isolated hypertension), kidney disease (like diabetes), kidney or liver disorders, neurologic/neuromuscular, or metabolic disorders. Moderate or severe acute illness with or without fever is a general precaution for vaccination Guillain-Barre Syndrome (GBS) within 6 weeks following a previous dose of influenza vaccine is considered a precaution for use of all influenza vaccines Treatment with nasal decongestants, nasal antibiotic and/or steroid preparations will not be allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Bischoff, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest School Of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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Evaluation of Free Air Portable Air Powered Respirator

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