Influenza A 2009 H1N1 Challenge Study in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background:

      - A challenge study exposes a person to a disease and allows researchers to study the disease
      through the body's healing process. An influenza challenge study that looks at different
      amounts of the flu virus can provide more information on the smallest amount needed to cause
      an infection. Researchers want to give one dose of the Influenza A H1N1 virus to healthy
      volunteers to see how the body responds to the virus.

      Objectives:

        -  To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate
           flu infection in a healthy adult.

        -  To study how the body s immune system responds to the virus.

      Eligibility:

        -  Healthy volunteers at least 18 years of age.

        -  Participants must be willing to remain in isolation for a minimum of 9 days.

      Design:

        -  Participants will be admitted to a hospital inpatient isolation unit. They will be
           screened with a physical exam and medical history. They will also have heart and lung
           function tests. Blood, urine, and nasal swab/wash samples will be collected.

        -  Participants will receive a single nasal spray of the flu virus. They will stay on the
           inpatient unit for at least 9 days.

        -  Participants will be monitored for the length of their stay. They will have frequent
           blood tests and other procedures as needed.

        -  Participants will be allowed to go home once they have had two negative tests for the
           virus. The tests will be given on two consecutive days....
    

Detailed description: 
      The high morbidity and mortality associated with both pandemic and seasonal influenza, and
      the anticipation of future influenza pandemics, puts influenza front and center in infectious
      disease research. Because the natural history and pathogenesis of human influenza has not
      been well characterized and cannot be adequately studied in animal models or with current in
      vitro techniques, important questions about influenza pathogenesis can only be approached
      through human challenge studies.

      Previous human challenge studies have addressed some aspects of the natural history of
      influenza by evaluating the timing of viral replication, shedding, clinical symptoms, and
      innate and adaptive immune responses. Although these studies have provided important
      information, in the United States, all but 1 were performed prior to 1990. Without exception,
      these studies had limitations due to the scope of the study and/or the scientific techniques
      available at that time.

      The primary objective of this study is to determine the dose of influenza A 2009 H1N1 human
      challenge virus that will induce a mild to moderate uncomplicated influenza infection in
      healthy volunteers. This protocol will examine some of the basic questions that remain
      unanswered regarding the pathogenesis of influenza in humans, namely, a detailed clinical and
      immunological characterization of uncomplicated influenza viral pathogenesis in healthy adult
      volunteers.

      Secondary objectives will evaluate clinical disease, length of viral shedding, and
      pathogenesis in those with influenza infection including identification of clinical markers
      of the disease. Notably, the exploratory objectives will seek to discover viral factors
      necessary for human infection/adaptation and to evaluate host immune response, viral
      replication, viral fitness, and the intrahost evolution.

      Collaboration between National Institute of Allergy and Infectious Diseases (NIAID)
      investigators and outside scientists will generate opportunities to further develop and
      expand areas of clinical influenza research based on the proposed challenge model.
    

Intervention name(s): Ca/04/2009/H1N1 Vero Grown Challenge Virus
Intervention type(s): Biological
Intervention description(s): The human challenge virus will be administered intranasally to each participant using a nasal sprayer. A total volume of up to 1 mL of virus will be administered.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: H1N1; Influenza; Human; Challenge Study; Healthy Volunteer