Safety and Efficacy of an H1N1 Influenza Vaccine in People With Asthma
Condition: H1N1 Influenza Virus
MeSH terms: Influenza, Human
Intervention: H1N1 vaccine high dose; H1N1 vaccine low dose
Intervention description: 30 mcg of unadjuvanted Novartis H1N1 vaccine delivered as two, 15 micrograms (mcg), intramuscular injections. Each 30 mcg dose is administered 21 days apart.; 15 mcg of unadjuvanted Novartis H1N1 vaccine delivered in two intramuscular injections 21 days apart
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 390.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Influenza A Virus, H1N1 Subtype; Vaccine

Summary:

      The purpose of this study is to assess the safety and the body's immune response (body's
      defense against disease) to an experimental H1N1 influenza vaccine in people with asthma. The
      study will enroll 350, and possibly up to 400 healthy adults ages 12 and older with mild,
      moderate, or severe asthma. Participants will be randomly assigned to 1 of 2 possible vaccine
      groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1
      vaccine given as two 15 mcg injections. Both groups will receive vaccine injections on days 0
      and 21.

      Study procedures include: medical history, physical exam, spirometry, maintaining a memory
      aid and, and blood sample collection. Participants will be involved in study related
      procedures for approximately 7 months.
    

Eligibility criteria:

        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