Evaluation of Free Air Portable Air Powered Respirator

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Free Air Portable Air Powered Respirator System for Prevention of Influenza Transmission

Conditions
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Influenza

Intervention / Treatment
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* Other: Free Air Portable Air Powered Respirator
* Other: N95 Respirator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N95 Respirator<br>Participants in this arm will wear an N95 respirator and safety goggles during Live Attenuated Influenza Vaccine exposure. | Other: N95 Respirator<br>* The N95 respirator is a mask that is standardly used clinically at Wake Forest Baptist Health.<br>|
| Experimental: Free Air Portable Air Powered Respirator<br>Participants in this arm will wear a Free Air PAPR and safety goggles during Live Attenuated Influenza Vaccine exposure. | Other: Free Air Portable Air Powered Respirator<br>* The Free Air PAPR is a portable air powered respirator that you will wear like a backpack with a mask and tubing attached.<br>* Other names: Free Air PAPR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Swabs | A nasal swab will be performed immediately following the exposure. | Immediately following Live Attenuated Influenza Vaccine exposure | 
| Nasopharyngeal swabs | A nasopharyngeal swab will be performed immediately following the exposure. | Immediately following Live Attenuated Influenza Vaccine exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Live Attenuated Influenza Vaccine (FluMist), Free Air Portable Air Powered Respirator, N95 Respirator, Personal Protective Equipment, Viral Transmission