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

Completed · Phase 2

Conditions studied: H1N1 Influenza Virus

In brief

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.

Key facts

Study ID: NCT00978120
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 390
Starts: 2009-10-01
Expected to finish: 2010-09-01
Last updated by the study team: 2012-08-10

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Emory University — Atlanta, Georgia, United States
Washington University School of Medicine — St Louis, Missouri, United States
Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
University of Pittsburgh Asthma Institute — Pittsburgh, Pennsylvania, United States
University of Virginia — Charlottesville, Virginia, United States
University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.