Blood and Plasma Collection For Use in Future H1N1 (Swine Flu) Clinical Trials

Treatment options are limited for the new strain of the H1N1 influenza virus, which differs from the seasonal H1N1 influenza virus. This study will collect blood from people who have been exposed to the H1N1 virus or who have received the H1N1 or seasonal influenza vaccine. The blood plasma will be used in a future clinical trial to treat people hospitalized with H1N1 influenza.

Swine origin influenza virus (A/H1N1), commonly referred to as "swine flu," is a new influenza virus, which differs from the seasonal H1N1 influenza virus. Most people will not have immunity to this new H1N1 virus strain. There is a concern that this virus will become resistant to oseltamivir (commonly known as Tamiflu), as resistance to this medication has been observed in people with the seasonal H1N1 influenza virus. Because of the possibility of drug resistance, additional treatment options for the H1N1 virus are needed. The purpose of this study is to collect blood from people who have been exposed to the H1N1 virus or who have received the H1N1 vaccine or a seasonal influenza vaccine. The blood will then be processed into Food and Drug Administration (FDA)-licensed fresh frozen plasma (FFP). In a future clinical trial, this plasma will be used as a treatment for people hospitalized with H1N1 influenza.

This study will enroll people who have recovered from H1N1 influenza, received the H1N1 vaccine or seasonal influenza vaccine after July 2010, or have both recovered from H1N1 influenza and received the H1N1 vaccine. Participants will donate blood at FDA-licensed blood donor centers up to three times during the 240-day study period.

Participants will include people who have recovered from H1N1 influenza, received the H1N1 vaccine or seasonal influenza vaccine after July 2010, or have both recovered from H1N1 influenza and received the H1N1 vaccine.

• Kash JC, Qi L, Dugan VG, Jagger BW, Hrabal RJ, Memoli MJ, Morens DM, Taubenberger JK. Prior infection with classical swine H1N1 influenza viruses is associated with protective immunity to the 2009 pandemic H1N1 virus. Influenza Other Respi Viruses. 2010 May 1;4(3):121-7.
• Tang JW, Shetty N, Lam TT. Features of the new pandemic influenza A/H1N1/2009 virus: virology, epidemiology, clinical and public health aspects. Curr Opin Pulm Med. 2010 May;16(3):235-41.

Inclusion Criteria:

• Currently healthy individuals with a history suggestive of having anti-influenza H1N1 antibodies (either or both of the following):

  1. An influenza-like illness (e.g., fever, chills, malaise, cough, myalgias, nausea) consistent with novel H1N1 influenza or otherwise having met the Centers of Disease Control definitions for a suspected, probable, or confirmed case of H1N1. Participants must be at least 7 days past the resolution of fever and enroll within 12 months of illness.
  2. Vaccinated with a licensed or investigational novel H1N1 vaccine or seasonal influenza vaccine after July 2010; must be at least 14 days since the last vaccination and within 12 months of the last vaccination.
• Must be Department of Defense (DoD)/beneficiary
• Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) document
• A demonstrated H1N1 HAI titer of 1:160 or greater
• Must also meet all Standard-of-Care inclusion criteria for donation of blood or plasma at the FDA-licensed donor center prior to every donation session. More information on this criterion can be found in the protocol.

Exclusion Criteria:

• Donors that do not meet all Standard-of-Care FDA approved requirements for the donation of blood and production of FFP as determined by the FDA-licensed donor center prior to every donation session may be excluded from further participation in this study. Study exclusion will be determined by the principal investigator (PI) or lead investigator at the study site.

• Donors that fail the Standard-of-Care screening and Blood Borne Pathogen screening for the following blood borne pathogens at the donor center will be excluded:

  1. Anti-HIV-I/II
  2. Anti-human T-lymphotropic virus (HTLV)-I/II
  3. Anti-hepatitis C (HCV)
  4. Anti-hepatitis B core antigen (HBc)
  5. Anti-T. cruzi (enzyme immunoassay [EIA] for Chagas disease) (if required by the FDA-licensed donor center or becomes a nationwide FDA requirement)
  6. Hepatitis B surface antigen (HBsAg)
  7. Serologic test for syphilis
  8. HIV nucleic acid test (NAT)
  9. HCV NAT
  10. West Nile virus (WNV) NAT

• Participation in other medical research that includes:

  1. Studies that are currently ongoing or will start during the duration of this study that require more than 60 mL of blood to be donated in any 56-day period of time
  2. Administration of any unlicensed drug in the 3 months before study entry or during the duration of this study
  3. Administration of any unlicensed vaccine in the 12 months before study entry or during the duration of this study, with the exception of unlicensed influenza vaccine