Evaluation of Free Air Portable Air Powered Respirator

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.

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