Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma

Inclusion Criteria:

• Diagnosis of mild/moderate or severe asthma according to Severe Asthma Research Project (SARP) definitions and either a SARP participant or having prior participation in the studies or clinics of the investigators
• Males and females age 12 (inclusive) and older
• Females of child-bearing potential must not be pregnant and must agree to practice adequate contraception that may include, but is not limited to: abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
• Able to understand and comply with planned study procedures
• Will provide written informed consent and assent (if age appropriate) prior to initiation of any study procedures

Exclusion Criteria:

• Allergy to eggs or other components of the vaccine, including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein
• Positive urine pregnancy test within 24 hours prior to vaccination, if a female of childbearing potential
• Currently breastfeeding
• History of smoking 20 pack-years or greater (current or former smokers with a history of less than 20 pack-years can be included in the study)
• Has been previously diagnosed by a physician with chronic obstructive pulmonary disease, chronic bronchitis, emphysema, or cystic fibrosis
• Has received anticancer chemotherapy or radiation therapy (cytotoxic) within the past 36 months
• Has an active neoplastic disease or a history of any hematologic malignancy
• Has a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis
• Has been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within the past 10 years
• Receiving psychiatric drugs (subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to study entry, without de-compensating symptoms, will be allowed to enroll)
• History of receiving immunoglobulin, including anti-cytokine antibodies, or other blood product within the 3 months prior to vaccination in this study
• Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 141 follow-up call - 100 days after the second vaccination)
• Has received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study, or plan receipt of such vaccines within 21 days following the second vaccination
• Has a history of severe reactions following previous immunization with influenza virus vaccines
• Has an acute illness, including an oral temperature greater than 100.4°F, within 1 week of either vaccination
• Has a chronic neurologic or autoimmune disorder
• Has a history of Guillain-Barré Syndrome
• Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of vaccine response
• Has an ongoing asthma exacerbation or had an asthma exacerbation that was resolved less than 7 days prior to vaccination
• Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury, render the participant unable to meet the requirements of the protocol, or interfere with the successful completion of the study.
• Participated in a novel influenza H1N1 2009 vaccine study in the past two years or has a history of novel influenza H1N1 2009 infection or treatment
• Has known active HIV, Hepatitis B or Hepatitis C infection
• Has a history of alcohol or drug abuse in the last 5 years
• Plans to travel outside of North America in the time between the first vaccination and 42 days following the first vaccination
• Does not speak English primarily