A Pilot Study for Collection of Anti-Influenza A Immune Plasma
Condition: Influenza A Virus Infection; Swine Flu
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      Background:

        -  The influenza A virus can cause infections that lead to fever, cough, muscle aches,
           diarrhea, and headaches, and can even be fatal in some people. Seasonal influenza kills
           an estimated 36,000 people in the United States each year. In addition, more than
           200,000 people are hospitalized for flu-related complications. Influenza A has a
           substantial health effect on every age group.

        -  Currently, treatments are available for influenza A, but there is concern that the rate
           of complications or even death from this infection is still high despite treatment, and
           that over time this virus may become resistant to these treatments. Researchers are
           interested in developing a possible new treatment that uses antibodies against influenza
           A virus.

      Objectives:

      - To collect plasma (the liquid component of blood containing antibodies) from people who
      have high levels of antibodies against the influenza A virus because they either have been
      previously infected with the virus or have been vaccinated against the infection.

      Eligibility:

        -  Healthy male volunteers between 18 and 60 years of age who are eligible to donate blood.

        -  Individuals must have previously either recovered from influenza infection or have been
           vaccinated against the infection, and may be subject to other restrictions on
           participating in National Institutes of Health research studies.

      Design:

        -  Volunteers will undergo apheresis, an outpatient procedure in which researchers will
           collect plasma containing antibodies against the influenza virus by drawing blood into a
           special machine that separates blood cells from the liquid portion under sterile
           conditions and then returns the blood cells to the donor.

        -  Volunteers will be screened with blood tests to ensure that they are eligible to
           participate and donate blood.

        -  Volunteers are asked to undergo at least 3 sessions of apheresis; if willing, they can
           volunteer to participate in up to 20 sessions.

        -  After plasma is collected, it will be tested to ensure that it can be used to safely
           develop treatments for patients who have influenza A infection.
    

Detailed description: 
      Two types of influenza A widely circulate in humans and cause seasonal outbreaks and
      epidemics - H1N1 (swine flu) and H3N2 (a subtype abundant in seasonal influenza). During the
      2009-2010 influenza season, the most commonly reported virus was influenza A (H1N1). However,
      during the 2010-2011 influenza season, the most commonly reported virus was influenza A
      (H3N2), but influenza A (H1N1) viruses and influenza B viruses circulated as well.

      A certain age group may be hit harder by one type of influenza virus than another (for
      example, the 2009 H1N1 virus disproportionately affected people younger than 65 years of age
      rather than those older than 65, whereas H3N2 virus often affects those older than 65 years).
      However, influenza A has a substantial health effect on every age group.

      Due to the limited therapeutic options for influenza and significant morbidity and mortality
      despite treatment, additional therapeutics are warranted. One potential therapeutic that is
      fairly rapidly available is the use of anti-influenza A immune plasma as immunotherapy.

      The objective of this protocol is collection of anti-influenza A immune plasma from male
      volunteers that meet criteria for use in human plasma therapy studies. The use of plasma from
      male donors will minimize the risk of transfusion related acute lung injury (TRALI), which
      has been associated with antibodies (likely generated during pregnancy) found in female
      plasma. For this reason, only male donors will be enrolled.

      This protocol does not administer any investigational product, but rather collects plasma
      from subjects with a high anti-influenza A antibody titer (convalescent survivors of
      influenza infection or recipients of a licensed influenza vaccine).

      Following screening of potential subjects to identify those who are not eligible to
      participate in plasma donations and to determine the likelihood of having antibodies to
      influenza A (H1N1 or H3N2) from a recent infection or immunization, enrolled subjects will
      receive a baseline physical and laboratory examination. Eligible subjects with high influenza
      A hemagglutination inhibition (HAI) titers will then be scheduled for at least 3 (and up to
      20) plasma collection sessions. Following testing of the collected plasma for potential
      pathogens, it may be used as therapeutic plasma, and/or it may be used for the manufacturing
      of high titer anti-influenza A intravenous immune globulin (IVIG). Both options would support
      clinical trials aimed at developing additional therapeutics for influenza infection.
    

Intervention name(s): Plasma collection following infection or vaccination with influenza A
Intervention type(s): Biological
Intervention description(s): High titer influenza A plasma collection for use as therapeutic plasma in influenza treatment studies.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male subjects with a history consistent with influenza infection and/or vaccination against
        influenza.
      
Keywords: Antibody Treatment; Immune Therapy; Infectious Diseases; IVIG; Plasma Apheresis; Influenza A; Swine Flu