Responses to Live Attenuated Influenza Virus (LAIV) in Chronic Obstructive Pulmonary Disease (COPD)

This is an interventional basic science trial for COPD Read More

Inclusion Criteria:

In order to be eligible to participate in this study, an individual in the COPD group must meet all of the following criteria:

• Age>40 years old
• Physician diagnosis of COPD confirmed by post-bronchodilator testing (defined as forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)< lower limit of normal and FEV1/FVC<0.70) and FEV1>30% predicted at screening
• Free of acute exacerbation of COPD for prior four weeks at time of recruitment
• Resting oxygen saturation >94 percent
• Blood pressure systolic values between 90-160 mm Hg and diastolic between 55-90 mm Hg
• No nasal symptoms based on questionnaire
• Willingness and ability to participate in study procedures
• Completion of informed consent

In order to be eligible to participate in this study, an individual in the healthy control group must meet all of the following criteria:

• Age>40 years old
• Spirometry testing showing normal lung function (defined as pre and post--bronchodilator FEV1/FVC>=lower limit of normal and FEV1>80 percent predicted) at screening
• Resting oxygen saturation >94 percent
• Blood pressure systolic values between 90-160 mm Hg and diastolic between 55-90 mm Hg
• No nasal symptoms based on questionnaire
• Willingness and ability to participate in study procedures
• Completion of informed consent

Exclusion Criteria:

• Inability or unwillingness to consent
• Active tobacco or e-cigarette use (within last six months)
• Active diagnosis of asthma
• Any regular suppressive antibiotics (i.e., azithromycin)
• Daily oral prednisone use
• Any supplemental oxygen use beyond nocturnal oxygen therapy
• Use of intranasal corticosteroids in the 30 days prior to screening visit
• Chronic illness associated with immunosuppression (i.e., HIV, malignancy)
• History of documented or self-reported positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection requiring hospitalization
• Receipt of SARS-CoV-2 vaccine within 14 days prior to study screening visit or plan to receive SARS-CoV-2 vaccine from screening visit to 14 days after completion of all study procedures
• History of epistaxis, prior nasal surgery or anatomical abnormalities
• Current use of blood thinner beyond full dose aspirin [e.g., warfarin (coumadin), clopidogrel (Plavix), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis)]
• Self-reported history of easy bruising or bleeding gums
• Serological evidence of HIV infection at screening (Positive HIV antibody test)
• Relative leukopenia (WBC<4000), neutropenia (Absolute neutrophil count<2000) or lymphopenia (absolute lymphocyte count<1500) on screening CBC
• Respiratory infection (cough, sore throat, sinusitis, fever) within prior 4 weeks
• Active wheezing at day 0 visit
• Pregnancy or nursing or women who are currently trying to become pregnant. (All female subjects, except those who have had a hysterectomy with oophorectomy, will undergo urine pregnancy testing on the morning of the screening visit and again on the on Day 0 at the time of arrival to the lab and prior to LAIV administration. A positive pregnancy test will exclude the subject)
• Use of chronic immunosuppression in the 30 days prior to screening visit
• History of hypersensitivity, especially anaphylactic reactions, to egg proteins, gentamicin, gelatin, or arginine, or with a reaction to previous influenza vaccination at a severity level precluding the subject's participation as judged by the study physician
• History of Guillain-Barre syndrome
• Subjects who will be unable to avoid contact with immunocompromised individuals for 3 weeks after receiving LAIV vaccine
• Receipt of the LAIV during the current or prior flu vaccine season
• Physician diagnosed influenza, a positive test for influenza or suspicion of influenza illness in the 18 months prior to enrollment. Suspicion of influenza will be based on the CDC's influenza-like illness case definition ("fever>100 °F AND cough/sore throat in the absence of a known cause other than influenza. Temperature can be measured in the office or at the home")
• Any condition that, in the opinion of the study investigator, would compromise the subject's ability to participate in the study