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A Pilot Study for Collection of Anti-Influenza A H1N1 (Swine Flu) Hyper-Immune Plasma


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  • Purpose

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    Background:

    • The influenza virus can cause infections that lead to fever, cough, muscle aches, diarrhea, and headaches, and can even be fatal in some people. A new type of influenza, called novel H1N1 influenza (or swine flu), affects people of all ages and in some situations has been reported to have a higher rate of death than seasonal influenza.
    • Currently, treatments are available for this influenza, 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 this virus.
    Objectives:
    • To collect plasma (the liquid component of blood containing antibodies) from people who have high levels of antibodies against the novel H1N1 influenza virus because they either have been previously infected with the virus or have been vaccinated against the infection.
    Eligibility:
    • Healthy individuals between 18 and 60 years of age who are eligible to donate blood.
    • Individuals must have previously either recovered from novel H1N1 influenza or have been vaccinated against the infection, and may be subject to other restrictions on participating in National Institutes of Health research studies.
    Design:
    • Participants 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 3 sessions of apheresis; if willing, they can volunteer to participate in up to 10 sessions.
    • After plasma is collected, it will be tested to ensure that it can be used to safely develop treatments for patients who have novel H1N1 flu.


      status: recruiting
      conditions: H1N1 Influenza ; Swine Flu
      phase: N/A
      study type: Observational
      study design: Other
      official title: A Pilot Study for Collection of Anti-Influenza A H1N1 (Swine Flu) Hyper-Immune Plasma

    • Further study details (as provided by National Institutes of Health Clinical Center (CC))

      enrollment: 200

      study start date: September 2009


      Detailed description

      Influenza A/H1N1 (commonly referred to as "swine flu") is a novel influenza virus. Most people will not have immunity to it. Currently there is no vaccine for this novel H1N1 virus. The Centers for Disease Control (CDC) anticipates that there will be more cases, more hospitalizations and more deaths associated with this new virus in the ensuing weeks.
      As of May 25, 2009, 46 countries have reported 12,515 cases of influenza A (H1N1) infection.
      Initial reports suggested a high mortality rate (6-7%), however most recent statistics suggest a mortality rate of 0.7% (91 deaths in 12,515 cases).
      Circulating H1N1 isolates are highly resistant to amantadine and rimantadine, and so there is concern this virus may also acquire oseltamivir resistance that is seen in circulating seasonal H1N1 virus. The future course of this epidemic is not clear. Due to the uncertainty of how the outbreak will progress and the limited therapeutic options for influenza, additional therapeutics for H1N1 are warranted. The objective of this protocol is collection of high titer anti-influenza H1N1 (swine flu) plasma from human volunteers.
      This protocol does not administer any investigational product, but rather collects plasma from subjects with a high anti-influenza novel H1N1 (swine flu) antibody titer (convalescent survivors of natural novel H1N1 infection or recipients of the novel H1N1 vaccine).
      Following screening of potential subjects to screen out those who are not eligible to participate in an apheresis protocol and to determine their likelihood of having previous exposure to novel H1N1 by recent infection or immunization, enrolled subjects will receive a baseline physical and laboratory examination. Eligible subjects with high novel H1N1 HAI titers will then be scheduled for three (and up to ten) apheresis sessions. Following testing of the collected plasma for potential pathogens, it may be used as a therapeutic plasma, and/or it may be used for the manufacturing of high titer anti-H1N1 IVIG. Both options would support clinical trials aimed at developing additional therapeutics for novel H1N1 infection.

    • Eligibility

      ages eligible for study: 18 Years to 59 Years
      genders eligible for study: Both

      Criteria

      • INCLUSION CRITERIA:
        1. Age greater than or equal to 18 years old, and < 60 years old
        2. History suggestive of having anti-influenza H1N1 antibodies (either of the
        following):
        • An influenza like illness (e.g. fever, chills, malaise, cough, myalgias and 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. Subjects must not be symptomatic and be at least seven days since the resolution of fever, and enroll within 6 months of illness.
        • Vaccinated with a licensed or investigational H1N1 vaccine at least 14 days since the last vaccination in the series.
          3. Adequate clinical parameters (all of the following):
        • Afebrile (temperature < 38 Degrees C)
        • Systolic blood pressure > 100 and < 180 mmHg
        • Diastolic blood pressure > 50 and < 100 mmHg
        • Heart rate between 40-100 beats/minute 4. Weight greater than or equal to 110 pounds (50 kg)
          5. Adequate peripheral venous access for plasmapheresis (as judged by the examiner)
          6. Willingness to have samples stored
          7. Females of child-bearing potential must (one of the following):
        • Be surgically sterile
        • Be abstinent (or willing to be) 4 weeks prior to date of screening evaluation through the last apheresis session (up to 120 days following enrollment in the protocol))
        • Use oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches, and have been using these for 3 months prior to date of screening evaluation through the last apheresis session (up to 120 days)
        • Use an intra-uterine device (IUD) as birth control 4 weeks prior to date of screening evaluation through the last apheresis session (up to 120 days)
        • Use (by ensuring her male partner(s) uses) barrier contraception (condom) as birth control 4 weeks prior to date of screening evaluation through the last apheresis session (up to 120 days)

        EXCLUSION CRITERIA:
        1. Any sign of active influenza, including but not limited to:
        • Subjective or documented fever (> 38 Degrees C)
        • Cough
        • Shortness of breath
        • Diarrhea
        2. Has a medical history of
        3. History of cancer that meets any one of the following criteria:
        4. Medication history that includes any of the following:
        5. Has ever had any of the following:
        • Sexual contact with someone known to have HIV
        • Had a relative with Creutzfeldt-Jakob Disease, or been told that this disease is inherited within the family
        • Received blood transfusion in the United Kingdom
        • History of receiving money, drugs or other payment for sex
        • History of receiving clotting factor concentrates
        • History of a dura mater graft
        • History of babesiosis
        • For male donors, history of sexual contact with another male
        • Used needles to take drugs, steroids, or other medications not prescribed by a physician
        • Was born, lived in, had blood donation in or ever had sexual contact with anyone who lived in Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, or Nigeria after 1977
        • History of living 3 or more months total (need not be consecutive) in the UK from 1980-1996
        • History of living 5 or more years total (need not be consecutive) in Europe since 1980
        • History of living 6 or more months total (need not be consecutive) on a U.S.
          military base in Europe from 1980-1996 (specifically from 1980 through 1990 in Belgium, the Netherlands, or Germany, and from 1980 through 1996 in Spain, Portugal, Italy, or Greece)
        6. Within the 8 weeks prior to enrollment:
        • Was vaccinated with the small pox vaccine, or was in close contact with someone who was vaccinated (i.e., close family member)
        7. Within the 3 months prior to enrollment has:
        • Current or previous participation in any other apheresis procedures/protocols (not related to this protocol)
        8. Within the last 4 weeks donated WBC or Platelets at any donor center
        9. Within the 4 months prior to enrollment has had:
        • A blood donation of a double unit of red cells
        10. Within the 12 months prior to enrollment has:
        • Received any blood or blood component
        • Donated blood at a paid donation center (donations at a hospital blood bank do not apply)
        • History of tattoo application
        • History of unsafe (multiple-use equipment) acupuncture, or piercing practices
        • Received an organ transplant
        • Received a bone or skin graft
        • Lived with someone who has any type of hepatitis
        • Been incarcerated for more than 72 hours
        • Oral or inhalation use of illegal drugs (i.e., those not prescribed by a physician)
        • Had or has been treated (with or without confirmatory diagnosis) for syphilis or gonorrhea
        11. Within the last 12 months has had sexual contact with (any of the following):
        • An individual having viral hepatitis
        • A prostitute or anyone else who takes money or drugs or other payment for sex
        • Anyone who has ever used needles to take drugs, steroids, or anything else not prescribed by their doctor
        • Anyone who has hemophilia or has used clotting factor concentrates
        • For females, a male who has ever had sexual contact with another male
        12. Participation in medical research that includes:
        • Protocols that are currently ongoing or will start during the duration of this study that require more than 100cc of blood to be given in any 8-week period of time
        • Administration of any unlicensed drug within the last 3 months or during the duration of this study
        • Administration of any unlicensed vaccine within the last 12 months or during the duration of this study, with the exception of unlicensed H1N1 vaccine
        13. Currently pregnant
        APHERESIS CRITERIA (all of the following):
        1. Novel H1N1 HAI titer of 1:80 or greater
        2. Adequate laboratory parameters (must meet all of the criteria below)
        • Hemoglobin level of greater than or equal to 12.5 grams/dL
        • HCT greater than or equal to 38%
        • Platelets greater than or equal to 150 times 10 (3)/micorL
        • Total serum protein greater than or equal to 6.0 grams /100 milliliters of blood
        • Quantitative immune globulin levels (all of the following)
          • Ig A greater than or equal to 90 mg/dL
          • Ig G greater than or equal 650 mg/dL
          • Ig M greater than or equal 35 mg/dL
        3. Negative serologic and molecular tests for blood borne pathogens, to include:
        • Anti-HIV-1/2
        • Anti-HTLV-I/II
        • Anti-HCV
        • Anti-T. cruzi (EIA for Chagas disease)
        • HBsAg (hepatitis B surface antigen)
        • Serologic test for syphilis (PK-TP)
        • HIV NAT
        • HCV NAT
        • WNV NAT
        4. Testing for Anti-HBc (hepatitis B core antibody) is a special case. A negative test
        is required for all components that will be issued as FFP or thawed plasma. A positive test result is acceptable for plasma that will undergo further manufacture into IVIG. Therefore, all subjects will be screened for anti-HBc, and those subjects found reactive (if other tests are negative) may have their components quarantined and labeled to indicate that they are only for use in further manufacture into IVIG.

    • Contacts and locations

      Please refer to this study by its ClinicalTrials.gov identifier: NCT00984451

      Contacts

      Patient Recruitment and Public Liaison Office   (800) 411-1222   prpl@mail.cc.nih.gov

      Locations

      United States , Maryland  - National Institutes of Health Clinical Center, 9000 Rockville Pike

      status: recruiting
      facility: Bethesda, Maryland, United States, 20892

    • Sponsors and collaborators

      National Institute of Allergy and Infectious Diseases (NIAID)

    • More information

      NIH Clinical Center Detailed Web Page

      Other publications

      Morse SS. Factors in the emergence of infectious diseases. Emerg Infect Dis. 1995 Jan-Mar;1(1):7-15. Review.

      Bean WJ, Schell M, Katz J, Kawaoka Y, Naeve C, Gorman O, Webster RG. Evolution of the H3 influenza virus hemagglutinin from human and nonhuman hosts. J Virol. 1992 Feb;66(2):1129-38.

      de Jong MD, Tran TT, Truong HK, Vo MH, Smith GJ, Nguyen VC, Bach VC, Phan TQ, Do QH, Guan Y, Peiris JS, Tran TH, Farrar J. Oseltamivir resistance during treatment of influenza A (H5N1) infection. N Engl J Med. 2005 Dec 22;353(25):2667-72.

      first received: September 24, 2009
      last updated: September 24, 2009
      ClinicalTrials.gov Identifier: NCT00984451
      health authority: United States: Federal Government

    Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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